Risks identified with using Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for multiple myeloma patients have emerged as bad news not just for the rights holder to that drug, Merck & Co (NYSE: MRK). A similar problem has best Bristol-Myers' (NYSE: BMY) Opdivo (nivolumab).
In July, the US Food and Drug Administration (FDA) placed a clinical hold on the KEYNOTE-183 and KEYNOTE-185 studies investigating Keytruda plus pomalidomide or lenalidomide, which are both drugs from US biotech Celgene (Nasdaq: CELG). Patients in the Keytruda/lenalidomide/dexamethasone cohort in the KEYNOTE-023 trial will also discontinue treatment.
On Thursday, it was announced that the FDA had also put a clinical hold on three multiple myeloma trials of combinations involving Opdivo (nivolumab), Bristol-Myers Squibb’s drug seen as Keytruda’s main immuno-oncology rival, as well as studies featuring Anglo-Swedish pharma major AstraZeneca’s (LSE: AZN) Imfinzi (durvalumab).
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