NEW YORK CITY (dpa-AFX) - Bristol-Myers Squibb Co. (BMY) said Monday that the U.S. Food and Drug Administration has approved Opdivo, a new treatment for patients with unresectable or metastatic melanoma who no longer respond to other drugs.
Opvido was approved under the FDA's accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. The program provides earlier patient access to promising new drugs while the company conducts additional clinical trials to confirm the drug's benefit.
The FDA granted Opvido breakthrough therapy designation, priority review and orphan product designation because the sponsor showed through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies; the drug had the potential, at the time of the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition; and the drug is intended to treat a rare disease, respectively.
Opdivo's efficacy was demonstrated in 120 clinical trial participants with unresectable or metastatic melanoma. Results showed that 32% of participants receiving Opdivo had their tumors shrink. This effect lasted for more than six months in about one-third of the participants who experienced tumor shrinkage.
The drug's safety was evaluated in the overall trial population of 268 participants treated with Opdivo and 102 participants treated with chemotherapy.
Melanoma is the fifth most common type of cancer in the United States. It forms in the body's melanocyte cells, which develop the skin's pigment. The National Cancer Institute estimates that 76,100 Americans will be diagnosed with melanoma and 9,710 will die from the disease this year.
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