AstraZeneca Takes “Anti-Avastin” Pledge On Accelerated Approval Withdrawal
Sponsor says it would offer to remove olaparib from the market if results from ongoing SOLO-2 trial in ovarian cancer maintenance setting are “not consistent” with Phase II efficacy data upon which accelerated approval is requested.
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Pink Sheet interactive timeline looks at key regulatory, policy and legislative developments impacting the accelerated approval pathway over the last 10 years.
AstraZeneca’s olaparib gains accelerated approval for fourth-line treatment of ovarian cancer – a different indication than the maintenance claim publicly vetted and rejected by FDA’s Oncologic Drugs Advisory Committee due to the drug’s toxicities and concerns about the reliability of progression-free survival data.
Oncologic Drugs Advisory Committee members divided on whether progression-free survival endpoint in AstaZeneca’s Phase III SOLO-2 trial could be used to support approval for maintenance therapy in relapsed ovarian cancer.