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FDA Grants Pembrolizumab Priority Review for TMB-High Tumors

Jason M. Broderick
Published: Tuesday, Apr 07, 2020

The FDA has granted a priority review designation to pembrolizumab (Keytruda) for the treatment of patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) status (≥10 mutations/megabase), as determined by an FDA-approved test, who have progressed following prior treatment and who have no satisfactory alternative treatment options.1

The ORR with pembrolizumab was 39.6% (95% CI, 31.7-47.9), including 11 (7.4%) complete responses and 48 (32.2%) partial responses. The ORR was 36% in patients with CRC and 46% in patients with other tumor types. The median duration of response was not yet reached (range, 1.6+ months to 22.7+ months). Among patients who responded to pembrolizumab, 78% had responses that lasted for at least 6 months.


  1. Merck Receives Priority Review from FDA for Second Application for KEYTRUDA® (pembrolizumab) Based on Biomarker, Regardless of Tumor Type. Published April 7, 2020. Accessed April 7, 2020.           
  2. Marabelle A, Fakih MG, Lopez J, et al. Association of tumor mutational burden with outcomes in patients with select advanced solid tumors treated with pembrolizumab in KEYNOTE-158. Ann Oncol (2019) 30 (suppl_5): v475-v532. 10.1093/annonc/mdz253
  3. FDA grants accelerated approval to pembrolizumab for first tissue/site agnostic indication. Published May 23, 2017. Accessed April 7, 2020.

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