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.
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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.
The agency is stressing that its new neoadjuvant pathway is intended for areas of high unmet need and won’t become the path of least resistance for pharma. But it is also signaling openness for testing drugs aimed at women with HER2-positive disease, who have a better prognosis and treatment options.
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.