FDA Issues Complete Response Letter for Trastuzumab Biosimilar

April 23, 2018 – Citing the need for additional technical information, the FDA has issued a complete response letter to Pfizer regarding a biologics license application (BLA) for the trastuzumab biosimilar PF-05280014. Pfizer had previously reported data from the REFLECTIONS B327-02 study (N = 707) at the 2017 ESMO Congress demonstrating that PF-05280014 had achieved equivalence in objective response rate (ORR) compared with trastuzumab when the agents were … (leggi tutto)