The FDA granted accelerated approval for Merck’s anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody Keytruda® (pembrolizumab) as a treatment for pediatric and adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair solid tumors that have progressed following prior treatment and for which there is no suitable alternative therapy and colorectal cancer (CRC) that has progressed following therapy with fluoropyrimidine, oxaliplatin, and irinotecan.
Merck says clearance was granted based on tumor response rates and durability of response, and that continued approval may depend upon data from confirmatory trials. “The FDA’s approval of this new indication for Keytruda further supports Merck’s commitment to helping people with difficult-to-treat cancers,” commented Roger M. Perlmutter, M.D., Ph.D., president, Merck Research Laboratories.
Earlier this month, Merck and Aduro agreed to carry out a clinical study combining the latter’s LADD® (Live, Attenuated Double-Deleted) Listeria-based immunotherapy with Keytruda in patients with malignant pleural mesothelioma. Also in May, Merck and Array BioPharma reported plans to carry out a clinical trial combining Array’s binimetinib with Keytruda in metastatic CRC with microsatellite stable tumors. Within the last 10 days, Noxxon Pharma and Germany’s National Center for Tumor Diseases signed a collaboration to carry out a Phase I/II study evaluating Noxxon’s lead Spiegelmer candidate with Keytruda in patients with metastatic pancreatic, and colorectal cancer.