The US Food and Drug Administration has waved through Bristol-Myers Squibb’s breakthrough skin cancer drug Opdivo (nivolumab) and BioCryst’s flu shot Rapivab.
B-MS’ breakthrough immunotherapy Opdivo (nivolumab) was approved as a new treatment for patients with unresectable or metastatic melanoma who no longer respond to other drugs.
Opdivo is intended for patients who have been previously treated with ipilimumab and, for melanoma patients whose tumors express a gene mutation called BRAF V600, for use after treatment with ipilimumab and a BRAF inhibitor.
The FDA has granted the drug breakthrough therapy designation and priority review, given that preliminary clinical evidence showed it may offer a substantial improvement over available therapies, as well as an orphan product designation.
The drug is also being 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.
Clinical data showed that 32% of participants receiving Opdivo had their tumors shrink, and in around one-third of these patients the effect lasted for more than six months.
Single flu shot
Elsewhere, BioCryst’s Rapivab (peramivir) was given the green light as a single-shot jab to treat influenza infection in adults.
The drug is the third neuraminidase inhibitor cleared by the FDA to treat flu infection, but it is the first approved as an IV formulation, noted Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
In trials, patients given Rapivab had their combined influenza symptoms alleviated 21 hours sooner than those receiving placebo, showing efficacy consistent with other drugs in the class, while patients recovered to normal temperature around 12 hours sooner compared to placebo.