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FDA Accepts Application for Adjuvant Pembrolizumab for Stage III Melanoma

Jason M. Broderick @jasoncology
Published: Monday, Jun 25, 2018

The FDA has accepted a supplemental biologics license application (sBLA) for the use of pembrolizumab (Keytruda) as an adjuvant treatment for patients with resected, high-risk stage III melanoma, according to Merck (MSD), the manufacturer of the PD-1 inhibitor.

= .0009). The 18-month RFS rates were 69.2% versus 52.4%, respectively.

Among BRAF wild-type patients, the 1-year RFS rate was 73.0% with pembrolizumab versus 59.7% with placebo (HR, 0.64; 99% CI, 0.42-0.96; = .0039). The 18-month RFS rates were 66.7% versus 48.8%, respectively. 

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