The FDA approval of pembrolizumab for adult and pediatric patients with tumor mutational burden (TMB) ≥10: a decision centered on empowering patients and their physicians
- PMID: 32771306
- DOI: 10.1016/j.annonc.2020.07.002
The FDA approval of pembrolizumab for adult and pediatric patients with tumor mutational burden (TMB) ≥10: a decision centered on empowering patients and their physicians
Conflict of interest statement
Disclosures VS: Research funding/grant support for clinical trials: Roche/Genentech, Novartis, Bayer, GlaxoSmithKline, Nanocarrier, Vegenics, Celgene, Northwest Biotherapeutics, Berghealth, Incyte, Fujifilm, Pharmamar, D3, Pfizer, Multivir, Amgen, Abbvie, Alfasigma, Agensys, Boston Biomedical, Idera Pharma, Inhibrx, Exelixis, Blueprint medicines, Loxo Oncology, Medimmune, Altum, Dragonfly Therapeutics, Takeda, and National Comprehensive Cancer Network, NCI-CTEP and UT MD Anderson Cancer Center, Turning Point Therapeutics, Boston Pharmaceuticals; Travel: Novartis, Pharmamar, ASCO, ESMO, Helsinn, Incyte; Consultancy/Advisory board: Helsinn, LOXO Oncology/Eli Lilly, R-Pharma US, INCYTE, QED Pharma, Medimmune, Novartis. Other: Medscape. DBS has consulted for/received honoraria from Loxo Oncology, Lilly Oncology, Pfizer, Vivideon Therapeutics, QED Therapeutics and Illumina. TAC is a co-founder of Gritstone Oncology and holds stock; receives research funding from Bristol-Myers Squibb (BMS), Pfizer, Illumina, Eisai, AstraZeneca, NysnoBio. He is a paid consultant of BMS, Illumina, AstraZeneca, An2H and holds patents for the use of TMB for prediction of clinical benefit from immune checkpoint inhibitors and receives royalties. RK receives research funding from Genentech, Merck Serono, Pfizer, Boehringer Ingelheim, TopAlliance, Takeda, Incyte, Debiopharm, Medimmune, Sequenom, Foundation Medicine, Konica Minolta, Grifols, Omniseq and Guardant, as well as consultant and/or speaker fees and/or advisory board for X-Biotech, Loxo, Neomed, Pfizer, Actuate Therapeutics and Roche, has an equity interest in IDbyDNA and CureMatch Inc, is a cofounder of CureMatch and serves on the Board of CureMatch and CureMetrix.
Comment in
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The FDA approval of pembrolizumab for patients with TMB >10 mut/Mb: was it a wise decision? No.Ann Oncol. 2020 Sep;31(9):1112-1114. doi: 10.1016/j.annonc.2020.07.001. Epub 2020 Aug 5. Ann Oncol. 2020. PMID: 32771305 No abstract available.
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