CANCER DIGEST – Dec. 22, 2014 – The FDA today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with melanoma that cannot be treated with surgery or have advanced disease who no longer respond to other drugs.
The FDA granted Opvido breakthrough therapy designation, priority review and orphan product designation because the sponsor demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies.
Opdivo’s safety was evaluated in the overall trial involving 268 participants treated with Opdivo and 102 participants treated with chemotherapy. Opdivo’s effectiveness was demonstrated in 120 clinical trial participants with melanoma that could not be treated with surgery or had spread to other parts of the body. Results showed that 32 percent of participants receiving Opdivo had their tumors shrink. This effect lasted for more than six months in approximately one-third of the participants who experienced tumor shrinkage.
Opdivo works by inhibiting the PD-1 protein on cells, which blocks the body’s immune system from attacking melanoma tumors. Opdivo is intended for patients who have been previously treated with ipilimumab (YERVOY®) and, for melanoma patients whose tumors express a gene mutation called BRAF V600, for use after treatment with ipilimumab and a BRAF inhibitor (Tafinlar and Zelboraf).
The most common side effects of the drug were rash, itching, cough, upper respiratory tract infections, and fluid retention (edema).
The FDA granted Opvido breakthrough therapy designation, priority review and orphan product designation because the sponsor demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies.
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