Merck announced that the FDA has approved KEYTRUDA, their anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for treating patients with Stage III-IVA cervical cancer as classified by FIGO in 2014. This approval is based on the Phase 3 KEYNOTE-A18 trial, which demonstrated that KEYTRUDA plus CRT significantly improved progression-free survival (PFS), reducing the risk of disease progression or death by 41% compared to a placebo with CRT.

Notably, this marks the 39th indication for KEYTRUDA in the U.S. and the third approved indication for treating cervical cancer. Dr. Bradley Monk emphasized the significance of this approval, as it offers a new treatment option for patients with newly diagnosed cervical cancer, potentially changing the treatment landscape.

The safety profile of KEYTRUDA includes immune-mediated adverse reactions that can be severe or fatal, affecting any organ system, sometimes simultaneously. These can occur during or after treatment and require early identification and management to ensure the safe use of KEYTRUDA. Depending on the severity of the adverse reaction, the drug should be withheld or discontinued, and appropriate corticosteroid therapy administered.

Dr. Gursel Aktan from Merck Research Laboratories highlighted the importance of KEYTRUDA plus CRT as the first anti-PD-1-based regimen approved in the U.S. for treating FIGO 2014 Stage III-IVA cervical cancer. It offers a new therapeutic option with the potential to improve outcomes for patients with this condition.

KEYTRUDA has previously been approved for use in combination with chemotherapy and as a single agent after chemotherapy fails. This latest approval expands the reach of KEYTRUDA as a cornerstone in the treatment of cervical cancer.

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.