Opdivo for advanced melanoma approved by FDA
US Food and Drug Administration
(HealthDay News) -- Opdivo (nivolumab) has received accelerated approval from the U.S. Food and Drug Administration to treat unresectable or metastatic melanoma that no longer responds to other drugs, the agency said Monday.
Opdivo inhibits the PD-1 protein on cells, which blocks the immune system from attacking melanoma tumors, the FDA said in a news release. The medication is intended for patients who have previously been treated with ipilimumab. For melanoma patients whose tumors express the BRAF V600 mutation, Opdivo is intended for use after treatment with ipilimumab and a BRAF inhibitor.
The drug's effectiveness was evaluated in clinical studies involving 120 people with unresectable or metastatic melanoma. Some 32 percent of people who took the drug had their tumors shrink, and this effect lasted for more than six months in about one-third of these people, the FDA said.
Common side effects included rash, itching, cough, respiratory infection, and edema. More serious adverse reactions included immune system reactions affecting healthy organs, including the lung, colon, liver, kidneys, or hormone-producing glands, the FDA said.
Opdivo is marketed by Bristol-Myers Squibb, based in Princeton, N.J.