Genentech’s Perjeta Passes Neoadjuvant Pathway Test, FDA Panel Says
Oncologic Drugs Advisory Committee members backing a claim for neoadjuvant treatment of early breast cancer cite pertuzumab’s special circumstances in cautioning that they are not opening the door wide to accelerated approval of other agents under an FDA draft guidance.
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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.
Genentech pledges to make new HER2-positive drug Perjeta (pertuzumab) available in the U.S. in two weeks, addresses FDA concerns about production issues and a potential shortage. Firm is already moving forward with plans for integrating Perjeta into its breast cancer portfolio, including combination with antibody-drug conjugate T-DM1.
FDA draft guidance lays out use of pathologic complete response to support accelerated approval of drugs for women with high-risk, early-stage breast cancer. Pathway allows for initial approval based on one pivotal study, which could be extended to assess survival and confirm clearance.