Oncologists Willing To Embrace pCR, Despite Potential Risks, ASCO Survey Finds
Ahead of Perjeta vote, impromptu survey of clinicians at ASCO Breast Cancer Symposium debate signals readiness to prescribe neoadjuvant drugs, based on pathological complete response data. ASCO President Clifford Hudis cautions of “serious risks to societal well-being with this approach.”
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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.
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FDA draft guidance lays out use of pathologic complete response to support accelerated approval of drugs for women with high-risk, early-stage breast cancer.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.