Avastin Breast Cancer Dispute Centers On “Magnitude Of Benefit” Questions
The decision on whether Avastin’s metastatic breast cancer indication should be retained may come down to three words – “magnitude of benefit.”
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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.
Submitting an NDA based on progression-free survival when other drugs for the indication have been approved on the basis of overall survival benefits is a risky proposition, but GlaxoSmithKline was confident the magnitude of Mekinist and Tafinlar’s PFS effect in metastatic melanoma would make the findings clinically relevant.