The U.S. Food and Drug Administration approved Bristol-Myers Squibb's skin cancer drug, more than three months before the scheduled review date.
Opdivo, or nivolumab, belongs to a promising new class of drugs designed to help the body's own immune system fight cancer by blocking a protein called Programmed Death receptor (PD-1).
The drug is the second PD-1 inhibitor to be approved by the FDA, the first being Merck's Keytruda in September.
Opdivo is intended for melanoma patients who have received prior treatment, including those who have been administered Bristol-Myers' cancer drug, Yervoy.
The National Cancer Institute estimates that 76,100 Americans will be diagnosed with melanoma, the deadliest form of skin cancer, this year and 9,710 will die from the disease.
The approval is based on trial data that showed 32 percent of patients receiving Opdivo saw their tumors shrink, compared with 11 percent of those given conventional chemotherapy.
The FDA was scheduled to review the drug on March 30.
Roche and AstraZeneca are also developing PD-1 inhibitors for different kinds of cancers.
Opdivo became the world's first approved PD-1 inhibitor in July when it received an approval in Japan. The drug is also being evaluated for use in other cancers, including lymphoma and lung cancer.
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