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FDA Agrees to Review Pembrolizumab (Keytruda) for First-Line Treatment of Advanced Melanoma

Approval decision expected in December

The FDA has accepted for review a supplemental biologics license application (sBLA) for pembrolizumab (Keytruda, Merck), an anti-programmed death-1 (PD-1) therapy.

Merck is seeking approval for pembrolizumab, at the currently approved dosage of 2 mg/kg every 3 weeks, for the first-line treatment of patients with unresectable or metastatic melanoma. The FDA granted priority review with a target action date of December 19, 2015. In addition, the FDA has extended the action date for a separate sBLA for pembrolizumab for the treatment of patients with ipilimumab-refractory advanced melanoma. The new action date is now December 24, 2015.

Pembrolizumab is currently indicated in the U.S. at a dosage of 2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression after ipilimumab and, if BRAF V600 mutation-positive, a BRAF inhibitor. This indication was approved under accelerated approval based on the tumor response rate and the durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent on verification and description of clinical benefit in confirmatory trials.

The sBLA submission for first-line use of pembrolizumab in advanced melanoma was based in part on data from the phase III KEYNOTE-006 trial, which evaluated pembrolizumab in 834 patients with unresectable or metastatic melanoma with disease progression. Findings from this study were published in the New England Journal of Medicine.

Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, pembrolizumab releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The incidence of melanoma has been increasing over the past four decades –– approximately 232,000 new cases were diagnosed worldwide in 2012. In the U.S., melanoma is one of the most common types of cancer diagnosed and is responsible for most skin cancer deaths. In 2015, an estimated 73,870 people are expected to be diagnosed and an estimated 9,940 people are expected to die of the disease in the U.S. The 5-year survival rate for patients with advanced or metastatic melanoma (stage IV) is estimated to be 15% to 20%.

Source: Merck; August 18, 2015.

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