Last week, Amgen (Onyx) announced negative news from its FOCUS clinical trial of multiple myeloma drug Kyprolis. Let’s put this into perspective. Continue reading
Tag Archives: Accelerated Approval
PARP inhibitor rejected by FDA Advisory Committee, then Approved for refractory patients
In June 2014, the FDA Oncology Drug Advisory Committee voted 11-2 to delay approval of AstraZeneca’s olaparib, a PARP (poly-ADP ribose polymerase) inhibitor for maintenance therapy in patients with ovarian cancer. The product received Accelerate Approval designation from the FDA, which provides for conditional approval pending follow-up studies, based on surrogate endpoints from Phase 2 trials, in this case, progression-free survival (PFS). Continue reading