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FDA Approves Two New Indications for Pembrolizumab in Advanced Melanoma

Dr. Richard Pazdur

Roger M. Perlmutter, MD, PhD

The FDA has expanded the approval for single-agent pembrolizumab (Keytruda) to include the frontline treatment of patients with advanced melanoma regardless of BRAF status, based on a substantial improvement in progression-free and overall survival compared with ipilimumab (Yervoy) in the phase III KEYNOTE-006 trial.1

In the KEYNOTE-006 study, which compared 2 pembrolizumab regimens with ipilimumab, the PD-L1 inhibitor reduced the risk of disease progression by >40% and the risk of death by >30%.

"As recently as five years ago, there were few treatment options for patients suffering from advanced melanoma," Roger M. Perlmutter, MD, PhD, president, Merck Research Laboratories, the developer of the PD-1 inhibitor, said in a statement. “Today’s news is another exciting milestone for Keytruda and for patients with this disease." Click here to read the full article at

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