FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old


The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.

“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing.”

According to the CDC, every year about 14 million Americans become infected with HPV; about 12,000 women are diagnosed with and about 4,000 women die from cervical cancer caused by certain HPV viruses. Additionally, HPV viruses are associated with several other forms of cancer affecting men and women.

Gardasil, a vaccine approved by the FDA in 2006 to prevent certain cancers and diseases caused by four HPV types, is no longer distributed in the U.S. In 2014, the FDA approved Gardasil 9, which covers the same four HPV types as Gardasil, as well as an additional five HPV types. Gardasil 9 was approved for use in males and females aged 9 through 26 years.

The effectiveness of Gardasil is relevant to Gardasil 9 since the vaccines are manufactured similarly and cover four of the same HPV types. In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine. The FDA’s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long term follow-up from this study.

Effectiveness of Gardasil 9 in men 27 through 45 years of age is inferred from the data described above in women 27 through 45 years of age, as well as efficacy data from Gardasil in younger men (16 through 26 years of age) and immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months.

The safety of Gardasil 9 was evaluated in about a total of 13,000 males and females. The most commonly reported adverse reactions were injection site pain, swelling, redness and headaches.

The FDA granted the Gardasil 9 application priority review status. This program facilitates and expedites the review of medical products that address a serious or life-threatening condition.

The FDA granted approval of this supplement to the Gardasil 9 Biologics License Application to Merck, Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc.

Cancer Is Tough, But The Leukemia & Lymphoma Society (LLS) Is Tougher


-LLS is leading the way to cancer cures, during Blood Cancer Awareness Month and beyond


Contributing to nearly every advance in blood cancer research and treatment in decades, The Leukemia & Lymphoma Society (LLS) has invested more than $1.2 billion in cancer research, with groundbreaking results in immunotherapy, genomics and personalized medicine that are improving and saving lives of patients. These revolutionary new treatments are powering LLS’s efforts to attack cancer from every angle.

Blood Cancer Awareness Month – every September – provides the opportunity for LLS, the world’s largest nonprofit dedicated to fighting blood cancer, to educate and engage the public about the blood cancers – leukemia, lymphoma and myeloma – which are the third leading cause of cancer deaths among Americans. LLS is at the forefront of the fight to cure cancer, dedicated to finding cures for the nearly 1.3 million people in the U.S. who are living with, or are in remission from, leukemia, lymphoma or myeloma and other blood cancers.

“Cancer is not a one-size-fits-all disease. We prioritize research based on unmet medical needs, and are ushering in a new era of cancer therapy that centers on giving the right treatment to the right patient at the right time,” said Louis J. DeGennaro, Ph.D., LLS president and CEO. “Further, we are seeing our vision for and approaches to treating the blood cancers now helping patients with other cancers, which is why we are proud to say that beating cancer is in our blood.”

Leukemia, Lymphoma and Myeloma – Latest Treatment Advancements

2017 was one of the most historic years on record for therapy approvals for blood cancers. In all, the U.S. Food and Drug Administration (FDA) approved 18 therapies to treat patients with blood cancers, and LLS supported 15 of them. To date, we have seen 10 FDA approvals for blood cancer therapies in 2018, and LLS has supported eight of these at some point in their development.

Leukemia. In 2017, the FDA approved a revolutionary treatment called CAR (chimeric antigen receptor) T-cell immunotherapy, a game-changing approach that involves genetically reprogramming a patient’s own immune cells to find and attack cancer cells. LLS supported the research leading to this discovery for more than two decades. The therapy, tisagenlecleucel (Kymriah®), was approved for children and young adults with acute lymphoblastic leukemia (ALL) who have relapsed more than once, marking significant progress for patients up to age 25 who have otherwise run out of treatment options.

After 40 years of little change in standard of care for patients with another deadly blood cancer, acute myeloid leukemia (AML), novel targeted therapies have been emerging at a rapid pace over the past year. Four therapies for AML, all supported with LLS investment, achieved FDA approval in 2017. Researchers are now able to home in on specific genetic drivers of the disease – opening to the door to a more personalized approach to treatment. In 2018 alone, the FDA approved two more new treatments for AML and several more are currently under FDA review.

Lymphoma. In 2017, the FDA approved a second CAR T-cell immunotherapy, axicabtagene ciloleucel (Yescarta®), bringing a new treatment option to adults with several types of relapsed and refractory large B-cell lymphomas. In May 2018, the FDA granted tisagenlecleucel its second approval, also for patients with several types of large B-cell lymphomas.

The FDA also approved another type of immunotherapy for a very rare subset of lymphoma called primary mediastinal large B-cell lymphoma (PMBCL) in June 2018. This immunotherapy, called pembrolizumab (Keytruda®), is known as a checkpoint inhibitor that works by releasing the brakes on the immune system so it can attack cancer cells. Pembrolizumab and another checkpoint inhibitor, nivolumab (Opdivo®), were also both recently approved for Hodgkin lymphoma patients who have relapsed from standard therapy.

Myeloma. Remarkable advances have been achieved over the past decade in treating myeloma. While a cure has not yet been achieved, survival rates have been dramatically extended with the median five-year survival rate improved from 34.6 percent in 2000 to 52.4 percent in 2015, thanks to a multitude of new therapies over the past decade. With so many new agents to work with, the next phase for physicians who treat patients with multiple myeloma is to optimize dosing and combinations.

CAR-T is now being tested in myeloma, targeting a protein on the surface of the cancer cells called BCMA. The data to date are encouraging, showing that the average median survival was extended for about a year with no significant safety risks. More than 95% of the 22 patients in the small early study responded; 50% had a complete response, meaning no cancer cells could be detected. While it’s not yet clear if cures are being achieved, the results are promising.

“Our long-term investment in research has resulted in significant breakthroughs leading to higher survival rates and lives saved, but at LLS, we do so much more,” DeGennaro shared. “To advance our mission we focus on cures and ensuring that patients have access to lifesaving therapies. We provide free information, education and support services for those who have been impacted by blood cancer. We fight for lifesaving policy changes at the state and federal level to ensure access to quality, affordable, coordinated care. We are committed to working tirelessly toward our mission every single day, until we find a cure.”

Cancer is a tough opponent, but at LLS, we are tougher.

While significant progress has been made, there is more work to be done. More than one-third of blood cancer patients still do not survive five years after their diagnosis. By funding the most innovative research, breakthroughs for patients who urgently need them can be achieved faster.

“Help raise awareness of blood cancer this month. Everyone can make an impact,” said DeGennaro. “Learn more about the LLS mission, volunteer and get involved in a fundraising campaign or donate to LLS directly. Join the fight this September, visit www.LLS.org to learn more. Beating cancer is in our blood.”

Singapore’s first clinical trial approval for T cell engineered (TCR) immunotherapy for treatment of Liver cancer


Lion TCR Pte. Ltd., a Singapore-based Biotech company receives approval from Health Sciences Authority (HSA), Singapore, for its Phase I/II multicentre clinical study of its product candidate (LioCyx™) for treatment of relapsed liver cancer post-liver transplantation. The first such trial in Singapore and for the region that uses precision T cell receptor (TCR) immune cell therapy to target Hepatitis B virus (HBV)-related liver cancer, which forms at least 80% of liver cancers in Asia. 80% of the 800,000 new liver cancer cases in the world yearly are diagnosed in Asia Pacific, including ChinaVietnamThailandIndonesiaSouth Korea and Singapore. Liver cancer is the world’s third most deadly cancer with very limited treatment options and poor treatment outcome. There is currently no effective treatment available for liver cancer relapsed patients post-liver transplantation.

LioCyx™ is developed by Lion TCR’s scientific founder, Prof. Antonio Bertoletti, a world-renowned HBV-liver cancer clinician scientist. Several Investigator-sponsored trials of LioCyx™ in Singapore and China have showed results of good safety profile and encouraging signs of efficacy. “We are very delighted with the approval of Phase I/II clinical trial of our LioCyx™, the first engineered TCR-T cell therapy for treatment of liver cancer in Singapore. It is an utmost encouragement on the recognition of innovative therapy for patients in need. Singapore HSA has been very efficient, transparent and professional in reviewing our application for the clinical trial of this innovative immunotherapy”, said Dr. Victor Li Lietao, founder and CEO of Lion TCR.

Patients recruitment for the Phase I/II clinical trial will begin with National UniversityHospital (NUH), Singapore. Lion TCR is in the midst of including more medical centres in Singapore and China into the trial.

More than 6,300 Pan-Mass Challenge Cyclists Hit the Road to Raise Record Breaking $52 Million During 2018 Ride


PMC Aims to Exceed $650 Million Raised for Cancer Care Advancements at Dana-Farber Cancer Institute with Most Ambitious Fundraising Goal to Date


Today, the Pan-Mass Challenge (PMC) commenced its 2018 ride, drawing in more than 6,300 cyclists from 43 states and ten countries to pedal varying routes across Massachusetts. On the heels of last year’s record-breaking fundraising campaign, in which the organization exceeded its goal by more than $3 million, this year’s participants will be riding with the hopes of collectively raising $52 million for cancer research and treatment at Dana-Farber Cancer Institute (Dana-Farber). The PMC, which raises more money for charity than any other single athletic event, is Dana-Farber’s largest single contributor, raising more than 53 percent of the Jimmy Fund’s annual revenue. If this year’s goal is reached, the PMC’s 39-year contribution to cancer research and care will exceed $650 million.

During Ride Weekend, the PMC unites cyclists ranging in age from 13 to 85 under the common mission of raising funds for cancer research and treatment. Designed to cater to all levels of cycling and fundraising abilities, the PMC offers riders the choice of 12 routes of varying distance, starting from 25 miles all the way up to the hallmark, two-day 192-mile ride passing through 46 towns from Sturbridge, Mass. through Provincetown that the organization is known for. Many ride in honor of a family member or friend lost to, or being treated for, cancer, as 100 percent of every rider raised dollar goes directly to Dana-Farber. At the cornerstone of the PMC community are more than 900 PMC riders and volunteers that are cancer survivors or current patients, considered “Living Proof” of the PMC spirit and mission to find a cure.

“Each year, I am in complete awe of the commitment and drive that our riders, volunteers, sponsors, staff and donors demonstrate as we work together towards our common goal of contributing critical funds to support the incredible advancements in cancer treatment and care being made at Dana-Farber,” said Billy Starr, founder and executive director of the PMC. “It’s been almost four decades yet is still humbling to say that once again, we are on track to increase our impact by raising even more money for Dana-Farber than last year. I’d like to wish my fellow riders a safe and successful PMC, and thank our community for their unwavering support.”

“I’m honored to pedal alongside this incredibly dedicated group of riders in the PMC this weekend. All of us at Dana-Farber have enormous gratitude for the commitment of the PMC community – the impact their contributions make on the cancer community worldwide is truly immeasurable,” said Laurie H. Glimcher, M.D., president and chief executive officer, Dana-Farber, who will be riding the 85-mile route to Bourne, Massachusetts. “The unrestricted funding provided by the PMC is crucial to the life-saving work being done at Dana-Farber and beyond by world-class physicians in pursuit of one day eradicating cancer.”

One-day routes include rides from Wellesley or Sturbridge to Bourne, Wellesley to Patriot Place and Bourne to Provincetown. Two-day routes include Wellesley or Sturbridge to Provincetown, and Wellesley or Sturbridge to Bourne and back. The average cyclist trains for three months, solicits 40 sponsors, and raises more than $7,000.

Started in 1980 when Billy Starr and 35 of his friends rode across Massachusetts and raised $10,200 for cancer research, the PMC is now recognized as the pioneering event that connected athleticism to charitable fundraising. Today, athletic fundraising events annually raise more than $4 billion, funding crucial programs at health and human service organizations nationwide.

The PMC is presented by New Balance and the Red Sox Foundation. Each year, an additional 200 companies support the event by providing more than $7 million in goods and services, and more than 4,000 volunteers donate their time to support the organization during Ride Weekend and beyond. To make a financial contribution to a rider, visit www.pmc.org, or call (800) WE-CYCLE. Connect with #PanMass2018 on Facebook, Twitter, Instagram and LinkedIn.

About the Pan-Mass Challenge

The Pan-Mass Challenge (PMC) is a bike-a-thon that today raises more money for charity than any other single athletic fundraising event in the world. The 39th PMC will take place on August 4 and 5, 2018. The PMC was founded in 1980 by Billy Starr, who remains the event’s executive director, an annual cyclist, and a fundraiser. The PMC has since raised $598 million for adult and pediatric patient care and cancer research at Dana-Farber Cancer Institute through the Jimmy Fund. The event donates 100 percent of every rider-raised dollar directly to the cause. The PMC generates more than 53 percent of the Jimmy Fund’s annual revenue and is Dana-Farber’s single largest contributor. The PMC has successfully melded support from committed cyclists, volunteers, corporate sponsors and individual contributors. All are essential to the PMC’s goal and model: to attain maximum fundraising efficiency while increasing its annual gift. The PMC’s hope and aspiration is to provide Dana-Farber’s doctors and researchers with the necessary resources to discover cures for all cancers. For more information on the Pan-Mass Challenge, log onto www.pmc.org.

Hyundai Hope On Wheels Presents Yale Cancer Center at Smilow Cancer Hospital With $100,000 Hyundai Impact Award To Support Pediatric Cancer Research


Hyundai Hope On Wheels® 501(c)(3) nonprofit organization celebrates its 20th year in the fight funding pediatric cancer research and will present Dr. Shilpa Hattangadi of Yale Cancer Center at Smilow Cancer Hospital with a $100,000 Hyundai Impact Award. This institution is one of 21 recipients of this year’s award, which is given to pediatric oncology departments at select children’s hospitals nationwide. The $100,000 Hyundai Impact Award will be officially presented to Dr. Hattangadi and Yale Cancer Center at Smilow Cancer Hospital on Wednesday, July 25th at 10:00 a.m.

In 2018, Hope On Wheels will award over $15 million toward pediatric cancer research and programs. This brings the organization’s donation total to $145 million since Hyundai joined the fight against pediatric cancer 20 years ago in 1998. With this latest grant, Yale School of Medicine has received more than $1,000,000 from Hope On Wheels.

“Throughout the country, talented doctors are working tirelessly to help kids fight cancer by conducting research or providing bedside care,” said Scott Fink, chairman, Hyundai Hope On Wheels Board of Directors. “Our goal at Hope On Wheels is to provide these doctors with the grant funds they need to perform their lifesaving work.”

During the event, children being treated at Yale Cancer Center’s who are battling cancer will participate in the program’s signature Handprint Ceremony, in which they’ll dip their hands in paint and place their handprints on a white canvas. Their colorful handprints on the canvas will represent their individual and collective journeys, hopes and dreams.

For more information about Hyundai Hope On Wheels and to view a complete list of this year’s grant winners, please visit HyundaiHopeOnWheels.org/research. Follow us on Facebook, Twitter or Instagram at facebook.com/HyundaiHopeOnWheels, twitter.com/HopeOnWheels or instagram.com/HyundaiHopeOnWheels.

Adlai Nortye Raises $53M in Series B

Business, Health

Adlai Nortye Biopharma Co., Ltd. (“Adlai Nortye” or “the Company”), a biopharmaceutical company, announced that it has raised $53 million in a Series B financing round. Leading investors in biotech including YuanMing Capital, Matrix Partners China, DT Capital Partners, and Yahui Precision Medicine Fund participated in this funding round.

Adlai Nortye is a clinical-stage biopharmaceutical company focusing on the discovery, development and commercialization of novel treatments for cancer, with primary concentration on immuno-oncology. Adlai Nortye is advancing a robust pipeline of more than 10 diverse product candidates. Over 20 members of its executive and core research and development team have worked for years as executives at top-tier biopharmaceutical companies in the world. This new round of investment will strengthen Adlai Nortye’s position to become a leading biopharmaceutical company for innovative drugs.

Adlai Nortye has two clinical stage immune-oncology product candidates. Reolysin®, an intravenously delivered immuno-oncolytic virus (IOV) for the treatment of solid tumors is ready to enter Phase III study. FDA has granted Fast Track designation for Reolysin®. This will facilitate the development, and expedite the review of the drug. The first-in-class EP4 antagonist AN0025 to treat solid tumors is currently in Global Phase Ib trial.

“We are extremely delighted to have the trust and support from China’s premier investors in this financing round. Adlai Nortye is totally committed to the development of innovative drugs in immune-oncology. We will work tirelessly to enhance the lives of cancer patients with a goal to turn cancer into a chronic disease”, said Carsten Lu, CEO of Adlai Nortye.

“YuanMing Capital focuses our investment on outstanding companies in the medical space, especially in advanced companies in life sciences”, said Lawrence Y. Tian, Ph.D., founding partner of YuanMing Capital. “We are confident in Adlai Nortye’s potential to evolve into a leader in the field of immune-oncology. We hope to support the innovative research and development, and fuel the growth of the company through close collaboration with Adlai Nortye.”

“Adlai Nortye is dedicated to shaping itself into a global I/O company. It has demonstrated strong ability of innovation and act proactively in the I/O space. Adlai Nortye has a world-class team with rich global experiences and definitive focus on execution under the leadership of CEO Carsten Lu. It truly stands out among competitions worldwide with its deep understanding of the requirements for clinical trials. I look forward to an even brighter future for Adlai Nortye”, commented Eric Yu, Ph.D., Director of Matrix Partners China.

First “Cancer Screen Week” Calls On Americans To Act Now Against Cancer By Taking Pledge To Get Screened


Genentech, American Cancer Society, Stand Up To Cancer and Rally Health launch initiative to increase earlier detection of certain cancers to help reduce death rates

State proclamations declare the first week of December as “Cancer Screen Week”

PR Newswire

ATLANTA and LOS ANGELES and SAN FRANCISCODec. 4, 2017 /PRNewswire-USNewswire/ — Genentech, a member of the Roche Group, the American Cancer Society (ACS), Stand Up To Cancer and Rally Health, today announced a new public health initiative called “Cancer Screen Week” urging every American to join together to make a difference in the fight against cancer by pledging to get their recommended cancer screenings. According to ACS, screening significantly increases the chances of detecting certain cancers early, when they are most likely to be treated successfully. Every pledge increases the potential impact “Cancer Screen Week” can have on saving more lives from cancer. This year, “Cancer Screen Week” will take place December 4-8, 2017, and annually thereafter the first week of December.

Even though about half of all men and a third of all women will be diagnosed with cancer at some point in their lives, the overall cancer death rate has dropped by 25 percent over the past 20 years. Improvements in cancer screening and earlier detection of cancer have contributed to this progress. “Cancer Screen Week” is an annual call to action for everyone to talk to their doctor and get their recommended cancer screenings, many of which may be covered by insurance.

“The American Cancer Society estimates that approximately 600,000 Americans were expected to die from cancer in 2017. Screening can catch many cancers early, when they’re most likely to be treated successfully. In fact, screening can actually prevent some cancers by finding and treating abnormalities that turn into cancer if left alone,” said Richard C. Wender, M.D., chief cancer control officer, The American Cancer Society. “‘Cancer Screen Week’ is a powerful reminder that it is possible to continue reducing cancer’s deadly toll through recommended regular screenings.”

Individuals can visit www.GetScreenedNow.org to take the pledge to get screened and receive a personalized list of recommended screenings, plus a list of simple actions they can take to help lower their risk for certain types of cancers. People who take the pledge are urged to encourage their family and friends to take the pledge as well. Employers and providers can visit www.CancerScreenWeek.org to find turnkey, customizable campaign materials they can use to promote cancer screenings among their employee and patient populations.

“We want to encourage people to take the ‘Get Screened Now’ pledge to find out what screenings are recommended for them, and then to talk to their doctor about cancer screening,” said Adam Bernstein, M.D., Sc.D., chief medical officer, Rally Health. “These simple steps might just save their life.”

Governors of ColoradoFloridaGeorgiaIowaKentuckyMarylandMichiganMinnesotaNew YorkOregonPennsylvania and Texas signed proclamations declaring the first week of December as “Cancer Screen Week” in their states, reinforcing the importance of cancer screening and early detection for their citizens.

“If collectively we can improve the rates for recommended cancer screenings, we have the potential to change the trajectory of cancer,” said Edith Perez, M.D., vice president and head of BioOncology, U.S. Medical Affairs, Genentech. “Awareness and education are important to be the best advocate for yourself and your loved ones.”

“We are proud to help launch ‘Cancer Screen Week’ to educate everyone that screening is the first line of defense in the fight against cancer,” said Stand Up To Cancer president and CEO Sung Poblete, Ph.D., R.N. “Following the screening guidelines will help people identify many cancers as early as possible, which means patients and their doctors will have more time to get the treatments that are best for them. Taking the pledge to get screened is an empowering first step.”

About “Cancer Screen Week”
Founded by Genentech, a member of the Roche Group, the American Cancer Society, Stand Up To Cancer and Rally Health, “Cancer Screen Week” is a public health initiative to increase awareness around the potentially lifesaving benefits of cancer screening. More information is available at www.CancerScreenWeek.org, including downloadable and customizable resources, such as a fact sheet, poster, pledge card and appointment reminder card, for insurance providers, employers, healthcare providers, advocates, professional organizations and people in the community who are interested in participating.

About American Cancer Society
The American Cancer Society is a global grassroots force of nearly 2 million volunteers dedicated to saving lives, celebrating lives, and leading the fight for a world without cancer. From breakthrough research, to free lodging near treatment, a 24/7/365 live helpline, free rides to treatment, and convening powerful activists to create awareness and impact, the Society is the only organization attacking cancer from every angle. For more information go to www.cancer.org.

About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit www.gene.com.

About Rally Health
Rally Health, Inc. is a consumer-centric digital health company that makes it easy for individuals to take charge of their health and collaborates with health plans, providers, and employers to engage consumers. The company’s flagship offering is Rally®, a digital health platform that offers a suite of online and mobile solutions that help consumers manage their health and health care needs: Rally EngageSM focuses on personalized health and well-being support; Rally ChoiceSM is a health benefits marketplace; and Rally ConnectSM offers care provider search and cost transparency. More than 30 million consumers have access to the Rally platform through more than 200,000 employers, and payers such as UnitedHealthcare, BlueCross BlueShield of South Carolina, Health Alliance, and thousands of employer groups. With offices in Washington, D.C.San FranciscoChicagoMinneapolis and Denver, the team behind Rally HealthSM has been working together since 2010 to transform the consumer health industry. For more information, please visit www.RallyHealth.com.

About Stand Up To Cancer
Stand Up To Cancer (SU2C) raises funds to accelerate the pace of research to get new therapies to patients quickly and save lives now. SU2C, a division of the Entertainment Industry Foundation (EIF), a 501(c)(3) charitable organization, was established in 2008 by film and media leaders who utilize the industry’s resources to engage the public in supporting a new, collaborative model of cancer research, and to increase awareness about cancer prevention as well as progress being made in the fight against the disease.

Current members of the SU2C Council of Founders and Advisors (CFA) include Katie CouricSherry LansingLisa PaulsenRusty RobertsonSue SchwartzPamela Oas WilliamsEllen Ziffren, and Kathleen Lobb. The late Laura Ziskin and the late Noreen Fraser are also co-founders. Sung Poblete, Ph.D., R.N., has served as SU2C’s president and CEO since 2011.

For more information on Stand Up To Cancer, visit www.StandUpToCancer.org.

FDA approves first biosimilar for the treatment of certain breast and stomach cancers

Health, Medicine

FDA approves first biosimilar for the treatment of certain breast and stomach cancers

Ogivri, a biosimilar to the cancer drug Herceptin, is approved for HER2+ breast cancer and metastatic stomach cancers

PR Newswire

SILVER SPRING, Md.Dec. 1, 2017 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer.

As with any treatment, health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients,” said FDA Commissioner Scott Gottlieb, M.D. “We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”

Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.

The FDA’s approval of Ogivri is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Ogivri is biosimilar to Herceptin. Ogivri has been approved as a biosimilar, not as an interchangeable product.

Common expected side effects of Ogivri for the treatment of HER2+ breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, difficulty sleeping (insomnia), cough and rash. Common expected side effects of Ogivri for the treatment of HER2+ metastatic stomach cancer include low levels of certain white blood cells (neutropenia), diarrhea, fatigue, low levels of red blood cells (anemia), inflammation of the mouth (stomatitis), weight loss, upper respiratory tract infections, fever, low levels of blood platelets (thrombocytopenia), swelling of the mucous membranes (mucosal inflammation), common cold (nasopharyngitis) and unusual taste sensation (dysgeusia). Serious expected side effects of Ogivri include worsening of chemotherapy-induced neutropenia.

Like Herceptin, the labeling for Ogivri contains a Boxed Warning to alert health care professionals and patients about increased risks of heart disease (cardiomyopathy), infusions reactions, lung damage (pulmonary toxicity) and harm to a developing fetus (embryo-fetal toxicity). Patients should stop taking Ogivri if cardiomyopathy, life-threatening allergic reactions (anaphylaxis), swelling below the skin (angioedema), inflammation of the lungs (interstitial pneumonitis) or fluid in the lungs (acute respiratory distress syndrome) occur. Patients should be advised of the potential risk to a developing fetus and to use effective contraception.

The FDA granted approval of Ogivri to Mylan GmbH. Herceptin was approved in September 1998 and is manufactured by Genentech, Inc.

For more information:
FDA: Information on Biosimilars
FDA: Biologics Price Competition and Innovation Act of 2009
FDA: Office of Hematology and Oncology Products

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.