Categorized | MRV Research, Regulatory

Genentech Files NDA For Two-Pill Combo In Melanoma In U.S.

Source: Clinical Leader, December 2014

Roche Group member Genentech announced that it has filed the New Drug Application (NDA) for its two-pill combo therapy cobimetinib and Zelboraf (vemurafenib) with the U.S. Food and Drug Administration (FDA) as treatment for BRAF V600 mutation-positive advanced melanoma.

Cobimetinib targets the protein MEK to keep it from allowing tumors to grow. Zelboraf is an authorized treatment for unresectable or metastatic melanoma with BRAF V600 mutation. While cobimetinib binds to MEK, Zelboraf binds to mutant BRAF in the protein series pathway. The combination of the two drugs is designed to disrupt the abnormal signaling in cell division which drives tumors to develop and survive. Genentech is developing cobimetinib in collaboration with Exelixis, which originally discovered the drug. The combo therapy of cobimetinib and Zelboraf is also under review by the European Medicines Agency (EMA).

The company’s submission is backed by positive results from the Phase 3 coBRIM study, where the combo therapy cut the risk of disease progression by half. Patients who were administered the combo therapy experienced significantly greater progression-free survival (PFS) of 9.9 months compared to Zelboraf monotherapy of 6.2 months. The results of the study were published in the New England Journal of Medicine earlier this year.

Though melanoma is a less common type of skin cancer, it is one of the more aggressive and life-threatening form of the disease. According to the American Cancer Society, an estimated 76,000 news cases of melanoma will be diagnosed in the U.S. this year, and the disease will claim 9,700 lives. The incidence of melanoma has been steadily rising over the last 30 years.

Sandra Horning, CMO and head of global product development at Genentech, said, “In the past several years, we have made significant progress in treating advanced melanoma, but it remains a serious and difficult to treat cancer that affects more people each year. We look forward to working with the FDA as they review the NDA and hope the combination of cobimetinib and Zelboraf will soon become a new option for people with BRAF mutation-positive advanced melanoma.”

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