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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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.
Under questioning from FDA’s Richard Pazdur, VP Sandra Horning says company would be willing to withdraw pertuzumab’s neoadjuvant indication if results from ongoing adjuvant study are “clearly negative”; advisory committee members say they expect sponsor to bow out more gracefully than it did in the fight over bevacizumab’s breast cancer claim.