FDA expands melanoma indication for Merck & Co.'s Keytruda

Merck & Co. announced Friday that the FDA expanded the indication for Keytruda (pembrolizumab) to include first-line treatment of patients with unresectable or metastatic melanoma, making it the first anti-PD-1 therapy cleared for previously untreated advanced melanoma patients regardless of BRAF status. Keytruda was initially approved last year to treat advanced or unresectable melanoma in patients who had already received Bristol-Myers Squibb's Yervoy (ipilimumab), or who had received Yervoy and a BRAF inhibitor if they were also carriers of the BRAF V600 mutation.

The expanded approval was based on data from the Phase III KEYNOTE-006 trial, which randomised 834 patients with unresectable stage III or IV advanced melanoma to receive Keytruda or Yervoy. Merck noted that patients had no prior therapy with Yervoy, and prior therapy with at most one other systemic treatment.

Results showed that patients treated with Keytruda every two weeks experienced a 37-percent reduction in the risk of death compared to Yervoy, while those assigned to receive Keytruda every three weeks had a 31-percent reduced risk of death. Median progression-free survival was 5.5 months and 4.1 months with the two-week and three-week Keytruda dosing schedules, respectively, versus 2.8 months with Yervoy.

"As recently as five years ago, there were few treatment options for patients suffering from advanced melanoma," remarked Roger Perlmutter, president of Merck Research Laboratories, adding that the latest approval "is another exciting milestone for Keytruda and for patients with this disease…including patients with very advanced disease and patients whose tumours carried BRAF mutations."

In July, the European Commission approved Keytruda to treat both first-line and previously-treated patients with advanced melanoma. The drug also recently gained accelerated approval in the US for patients with PD-L1-positive non-small-cell lung cancer whose disease progressed after prior treatment.

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