FDA Accepts sBLA for Pembrolizumab as Adjuvant Therapy for Melanoma

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If approved, the new indication could mean pembrolizumab could be used for patients with melanoma.
If approved, the new indication could mean pembrolizumab could be used for patients with melanoma.

The U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) as an adjuvant therapy following resection for high-risk stage 3 melanoma.1

The FDA is expected to take action on February 16, 2019.

The sBLA is based on data from a double-blinded, phase 3 EORTC1325/KEYNOTE-054 study (ClinicalTrials.gov Identifier: NCT02362594), which were presented at the American Association for Cancer Research (AACR) Annual Meeting 2018 and published in the New England Journal of Medicine.2

The study showed that 200 mg of pembrolizumab administered every 3 weeks for up to 1 year was associated with significantly longer recurrence-free survival compared with placebo (P< .001).

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Pembrolizumab is already indicated for the treatment of patients with unresectable or metastatic melanoma, and received FDA approval for this use in 2014.

The news follows an FDA announcement on May 18, 2018, that patients being treated with pembrolizumab for urothelial carcinoma with low levels of PD-L1 had decreased survival compared with patients who received cisplatin- or carboplatin-based chemotherapy.3


  1. FDA Accepts supplemental biologics license application for Merck's Keytruda (pembrolizumab) as adjuvant therapy in advanced melanoma. Merck website. http://www.mrknewsroom.com/news-release/oncology/fda-accepts-supplemental-biologics-license-application-mercks-keytruda-pembrol. Published June 25, 2018. Accessed June 25, 2018.
  2. Eggermont AMM, Blank CU, Mandala M, et al. Adjuvant pembrolizumab versus placebo in resected stage III melanoma. N Engl J Med.2018;378:1789-1801.
  3. Keytruda (pembrolizumab) or tecentriq (atezolizumab): FDA alerts health care professionals and investigators: FDA statement - decreased survival in some patients in clinical trials associated with monotherapy. FDA website. https://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm608253.htm. Published May 18, 2018. Accessed June 25, 2018.

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