In early October, the FDA granted accelerated approval for pembrolizumab (Keytruda) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease continued to progress after other treatments, and with tumors that have a protein called PD-L1.
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Lung cancer has a far larger patient population than melanoma, with NSCLC accounting for up to 90 percent of all cases, and is seen as a more lucrative use for the new medicines like Opdivo that help the immune system fight the disease. He continues, “For people battling this deadly disease, this approach provides real hope of long-lasting responses while avoiding the toxicities of typical chemotherapy”.
Patients with advanced non-small cell lung cancer who have progressed on platinum-based chemotherapy now have the option of treatment with nivolumab (Opdivo).
The FDA based its decision in part on results of a randomized study that included 582 patients with advanced NSCLC. Participants were given either nivolumab or docetaxel. According to the FDA statement, patients treated with nivolumab lived longer and experienced more tumor shrinkage than those who were treated with docetaxel.
The median overall survival was 12.2 months in the Opdivo arm and 9.4 months in the Docetaxel arm. Nineteen percent of patients treated with nivolumab experienced complete or partial shrinkage of tumors – which lasted an average of 17 months – compared with 12% of patients treated with docetaxel.
The most common side effects of Opdivo are fatigue, musculoskeletal pain, decreased appetite, cough and constipation. It also received priority review status, which is granted to drugs that, at the time the application was submitted, have the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition.
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While the expanded approval was widely expected based on clinical trial data, the FDA announcement came about three months ahead of the agency’s mid-January action data.
