Onyx’s Myeloma Drug Kyprolis Fits ODAC’s View On Accelerated Approval
FDA’s Oncologic Drugs Advisory Committee overwhelmingly endorsed the second-generation proteasome inhibitor for accelerated approval in the relapsed/refractory population. Onyx’s reliance on a single-arm study was appropriate given the lack of treatment options in a heavily pre-treated population, said ODAC members, who also looked favorably upon the company’s advanced plans for confirmatory trials.
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Novartis’ Panobinostat Review Panel Could Scrutinize Survival Data
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Navigating A Patient Centered World: What Works, What Doesn’t
Patients and patient foundations have become sophisticated players in the funding and translation of early stage medicines. Panelists at FasterCures’ Partnering for Cures conference shared some of the challenges that still remain in how patient groups and other stakeholders can best maximize partnership opportunities.