Companion Diagnostics In Oncologic Development: Idhifa And Lynparza Show Benefit Of Early Focus
Pink Sheet's Drug Review Profile looks at how Celgene's Idhifa sped from IND to approval, helped by prospective integration of a companion IDH2 mutation diagnostic into the clinical trial, while AstraZeneca's Lynparza was delayed by FDA concerns over retrospective analysis using germline BRCA mutation diagnostic.
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US FDA’s Information First Policy: PD-1 Bladder Cancer Alert Aligns With Complementary Diagnostics Perspective
Tecentriq and Keytruda's apparently lower efficacy in low PD-1/L1 patients in ongoing first-line trials prompts communication instead of restriction, underscoring FDA's emerging approach to precision medicine labeling.
Pipeline is concentrated around Phase II, but sponsors have a few chances to see how FDA handles its ‘foundational constructs’ for psychedelic drugs, led by Lykos’ pending NDA for PTSD and Compass Pathways’ Phase III synthetic psilocybin COMP360 for treatment-resistant depression.
Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.