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.
- Merck Receives Priority Review from FDA for Second Application for KEYTRUDA® (pembrolizumab) Based on Biomarker, Regardless of Tumor Type. Published April 7, 2020. https://www.mrknewsroom.com/news-release/oncology-newsroom/merck-receives-priority-review-fda-second-application-keytruda-pembro. Accessed April 7, 2020.
- 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
- FDA grants accelerated approval to pembrolizumab for first tissue/site agnostic indication. Published May 23, 2017.https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pembrolizumab-first-tissuesite-agnostic-indication. Accessed April 7, 2020.
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