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.
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ESMO In Brief: PD-1 Updates, Perjeta’s Striking Survival, Boehringer’s Gilotrif Head-to-Head EGFR Data & More
Data for Merck’s Keytruda in bladder cancer and AstraZeneca’s CTLA-4/PD-L1 combo were among the immunotherapy updates at the 2014 ESMO meeting. Other notable releases include Perjeta’s striking survival data, a possible reprieve in lung for Endocyte’s vintafolide and head-to-head lung cancer data for Boehringer’s afatinib.
Roche’s Perjeta suffered a knock-back in Europe when NICE said the clinical trial population was not wholly relevant to the patient population in the UK.
Genentech appears to be having significant manufacturing problems for some of its new cancer therapies. FDA hasn’t taken enforcement action yet, but the agency has delayed two approvals and tied them to post-market requirements to address QC issues.