FDA expands use for lung cancer drug

Soon after FDA granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC), it approved Opdivo (nivolumab) for an expanded use – to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease progressed during or after platinum-based chemotherapy.

Earlier this year, FDA approved Opdivo, manufactured by Bristol-Myers Squibb in Princeton, N.J., to treat patients with advanced squamous NSCLC. The October 9 approval expands the use of Opdivo to also treat patients with non-squamous NSCLC.

Keytruda, marketed by Merck & Co., in Whitehouse Station, N.J., is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors. The PD-L1 IHC 22C3 pharmDx diagnostic test is marketed by Dako North America Inc. in Carpinteria, Calif.

Related:Keytruda for lung cancer gets accelerated approval

Opdivo also works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, Opdivo may help the body’s immune system fight the cancer cells, according to the FDA.

“There is still a lot to learn about the PD-1/PD-L1 pathway and its effects in lung cancer, as well as other tumor types,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “While Opdivo showed an overall survival benefit in certain non-small cell lung cancer patients, it appears that higher expression of PD-L1 in a patient’s tumor predicts those most likely to benefit.”

 

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