Perjeta Approval Heralds Roche’s Next Wave Of Breast Cancer Drugs
This article was originally published in The Pink Sheet Daily
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.
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The bundled payment pilot program resulted in a 34% decrease in overall cancer treatment costs among participating medical centers despite a 179% increase in drug spending, according to results released July 8.
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.”
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in cautioning that they are not opening the door wide to accelerated approval of other agents under an FDA draft guidance.