“Not Another Avastin,” FDA Panel Warns Genentech At Perjeta Review
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.
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Confirmatory trial misses overall survival primary endpoint, raising question of whether US FDA will seek to revoke accelerated approval of PD-L1 inhibitor’s second-line bladder cancer indication, as it did with Avastin’s breast cancer claim.
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.
Genentech’s bevacizumab was associated with improved maintenance of baseline quality of life and performance status in a confirmatory trial conducted under accelerated approval, but an NCI-funded study found higher rates of neurocognitive decline, increased symptom severity and decline in health-related quality of life.