Perjeta, Avastin Breast Cancer Approvals Are A Study In Contrasts
Pertuzumab’s approval came almost a year after FDA and Genentech battled over the future of bevacizumab’s breast cancer claim at an unprecedented public hearing. While both oncologic agents were approved on the basis of a median progression-free survival benefit exceeding five months, the regulatory similarities end there.
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Neoadjuvant Surrogate Endpoint Is Tough Sell, But FDA Panel Says Perjeta Worth A Chance
Despite concerns about accelerated approval on the basis of pathological complete response, which has not yet been correlated with improvements in longer-term outcomes, FDA panelists say the large body of efficacy and safety data supporting Genentech’s pertuzumab makes it worth the regulatory risk.
Roche Oncology Turns In A Third Quarter To Rival The Good Old Days
Roche put up improved sales figures reflecting a 9% increase in oncology sales so far in 2012 and elaborated on its plan for continued growth in the face of eventual generic competition.
Genentech’s Perjeta Clears FDA Despite Unresolved Manufacturing Issues
In approving for marketing a finite supply of pertuzumab, FDA determined that the benefit of making a new breast cancer treatment available outweighs the risk that the drug could go into shortage due to production problems. The manufacturing concerns led to a split within the agency on the question of approval, with CDER Director Woodcock making the final call.