Perjeta’s Data, Not Regimen, Get FDA Reviewer Support Ahead Of ODAC
This article was originally published in The Pink Sheet Daily
Roche/Genentech’s HER2-targeted therapy pertuzumab has sufficient evidence for accelerated approval in neoadjuvant breast cancer, agency briefing documents conclude, but reviewers question use of an anthracycline-containing chemotherapy regimen.
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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FDA draft guidance lays out use of pathologic complete response to support accelerated approval of drugs for women with high-risk, early-stage breast cancer.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.
Despite lack of enthusiasm with immunobridging study data, the panel endorsed emergency use in certain at-risk populations, in part because it would be hard to turn down the Moderna booster when an identical EUA had been issued for Pfizer/BioNTech's mRNA vaccine.