FDA approves Bristol-Myers immunotherapy drug Opdivo
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Bristol-Myers Squibb Co’s immunotherapy drug Opdivo has received the green signal from USFDA to treat an advanced form of lung cancer.
The agency said Opdivo may now be used in patients with non-squamous non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy.
Opdivo, known chemically as nivolumab, was first approved to treat advanced melanoma, the deadliest form of skin cancer, and later for squamous non-small cell lung cancer.
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.
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.
The agency said Opdivo may now be used in patients with non-squamous non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy.
Opdivo, known chemically as nivolumab, was first approved to treat advanced melanoma, the deadliest form of skin cancer, and later for squamous non-small cell lung cancer.
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.
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.
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