Neoadjuvant Surrogate Endpoint Is Tough Sell, But FDA Panel Says Perjeta Worth A Chance
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.
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Modeling Is Not a Drug Approval Pathway: Why Merck Flunked Keytruda’s TNBC Advisory Panel
Advisory panel agrees with US FDA that Merck’s pathological complete response data is not strong enough for accelerated approval in high-risk, early-stage triple-negative breast cancer patients and says modeling of expected outcomes data cannot make up for this weakness.
FDA’s Early Breast Cancer pCR Final Guidance Stresses One Trial
Final guidance from FDA on accelerated approval pathway based on pathological complete response in neoadjuvant breast cancer clarifies that one large trial is the “default” for most applications.
Revised pCR Guidance Likely To Include Failed ALTTO Trial, FDA Says
Oncology office director Pazdur says whole data package supporting accelerated approval in neoadjuvant breast cancer of Roche’s Perjeta was far stronger than the data for GSK’s Tykerb, which just failed in ALTTO. FDA is standing by use of pCR as a surrogate endpoint but says only a select group of drugs will qualify.