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FDA draft guidance lays out use of pathologic complete response to support accelerated approval of drugs for women with high-risk, early-stage breast cancer.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.
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.