New immunotherapy drug for lung cancer gets early FDA approval

4 Mar 2015

U.S. health regulators approved Opdivo, a drug that helps the immune system fight the most common form of lung cancer. Opdivo, known chemically as nivolumab, was approved to treat non-small cell lung cancer after the disease has progressed following platinum-based chemotherapy, typically the first-line treatment against the disease.

Opdivo belongs to a highly promising new class of medicines called PD-1 inhibitors that work by blocking a mechanism tumors use to hide from the immune system, allowing it to recognize and attack cancer cells. This immunotherapy is marketed by Bristol-Myers Squibb.


Eagerly anticipated approval

Opdivo is being approved more than three months earlier than expected. The eagerly anticipated FDA approval of the drug came only after the publication of the trial results showing that the medicine extended survival in non-small cell lung cancer.

"This approval will provide patients and health care providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials," Richard Pazdur, the FDA's head of hematology and oncology product evaluation, said in a statement.

Common side effects

The most common side effects of Opdivo are fatigue, shortness of breath, musculoskeletal pain, decreased appetite, cough, nausea and constipation. The most serious side effects are severe immune-mediated side effects involving healthy organs, including the lung, colon, liver, kidneys and hormone-producing glands.

Opdivo was previously approved to treat patients with melanoma that is unresectable (cannot be removed by surgery) or metastatic, who no longer respond to other drugs.


Source: Reuters
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