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

Safety

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.

Clearbridge BioMedics’ ClearCell(R) FX1 system achieves U.S. FDA listing

Food, Governance

Clearbridge BioMedics today announced that it has successfully registered its target cell enrichment device, the ClearCell® FX1 system, with the U.S. Food and Drug Administration (FDA) as a Class I Medical Device, for in vitro diagnostic use. This registration marks a significant milestone in providing a reliable liquid biopsy solution for clinical research in the United States. The ClearCell® FX1 system has also previously attained CE marking to be used as an in-vitro diagnostic medical device in Europe and China Food and Drug Administration-approved Class I Medical Device status via the company’s MGI partnership.

The ClearCell® FX1 System is a leading, automated, label-free liquid biopsy device for the enrichment of target cells from blood. The system incorporates the innovative microfluidics CTChip® to isolate and retrieve intact, viable target cells from a patient’s blood sample.

Commercially launched in 2015, the ClearCell® FX1 System has since been installed in laboratories worldwide and empowered numerous liquid biopsy studies. In 2017, it was chosen to be part of the prestigious CANCER-ID consortium, where leading cancer institutes and researchers use the technology to better understand the underlying biology of circulating tumor cells (CTCs). The objective of such efforts is to generate new insights into the disease, to develop innovative cancer therapies and improve patient management protocols. The technology enables seamless processing of both CTCs and circulating tumor DNA (ctDNA) from the same patient sample for subsequent analysis, allowing comprehensive cancer profiling.

“We believe, the ClearCell® FX1 System will play a critical role in the development of new therapies by providing label-free, intact and viable cells for analysis. Successfully listing the unit with the U.S. FDA for in vitro diagnostic purposes will accelerate research and the adoption of diagnostics from the tumor cells obtained. We will continue to work with our partners and the authorities to further validate the system, for use in cancer diagnostics, personalized therapy management and patient monitoring,” said Michael Paumen, CEO of Clearbridge BioMedics.

In the U.S. the ClearCell® FX1 system is sold directly through Clearbridge BioMedics Inc. In EMEA and Asia, the platform is currently available in more than 22 countries through distribution partnerships. In China, it is available through a strategic partnership with MGI, an associate of BGI.

About Clearbridge BioMedics

Clearbridge BioMedics Pte Ltd specializes in developing innovative systems with applications in oncology research and diagnostics. Clearbridge BioMedics has won numerous awards and garnered global recognition for its novel Circulating Tumor Cell (CTC) detection platform technology, the ClearCell® FX1 System. The ClearCell® FX1 system, when used in conjunction with its biochip and associated accessories, utilize state-of-the-art, non-invasive liquid biopsy to process blood samples for enrichment of CTCs. This enables the real-time analysis of disease before, during, and after treatment, which has become increasingly critical in the new era of targeted cancer therapies. www.ClearbridgeBioMedics.com