FDA Approves Expanded Indication for Merck's Keytruda for Treatment of Advanced Melanoma

December 20, 2015

The FDA has approved an expanded indication for Merck’s Keytruda® (pembrolizumab), an anti-PD-1 (programmed death receptor-1) therapy, to include the first-line treatment of patients with unresectable or metastatic melanoma. This approval marks the second FDA-approved indication in advanced melanoma for Keytruda, which is now the first anti-PD-1 therapy approved for previously untreated advanced melanoma patients regardless of BRAF status. The FDA-approved dose of Keytruda is 2mg/kg every three weeks.

In a Phase 3 trial, KEYNOTE-006, patients with unresectable or metastatic melanoma who were treated with Keytruda experienced superior overall survival (OS) compared to those treated with ipilimumab. In this study supporting the first-line approval, patients given Keytruda 10mg/kg every two weeks demonstrated a 37 percent reduction in the risk of death and those given Keytruda 10mg/kg every three weeks demonstrated a 31 percent reduction in the risk of death, both compared to ipilimumab (hazard ratio: 0.63 [95% CI: 0.47, 0.83; p<0.001] and hazard ratio: 0.69 [95% CI: 0.52, 0.90; p=0.004], respectively).

Immune-mediated adverse reactions occurred with Keytruda including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Based on the severity of the adverse reaction, Keytruda should be withheld or discontinued and corticosteroids administered.

“As recently as five years ago, there were few treatment options for patients suffering from advanced melanoma,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “Today’s news is another exciting milestone for Keytruda and for patients with this disease. Data supporting the approval emerged from a large and diverse patient population, including patients with very advanced disease and patients whose tumors carried BRAF mutations, thus demonstrating both the breadth of our clinical development program for Keytruda, and the potential of Keytruda to extend the lives of those afflicted with this grievous malignancy.”

Keytruda (pembrolizumab) is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

“This growing body of evidence in patients with advanced melanoma supports the expanded indication for Keytruda,” said Dr. Omid Hamid, Director of the Melanoma Center at The Angeles Clinic and Research Institute, and a principal investigator for the Keytruda melanoma clinical program. “This approval highlights the importance of Keytruda for advanced melanoma, where we are in need of additional treatment options.”

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