Micromet, Inc (f/k/a MITI)

[surf1944]

7:34AM Micromet obtains FDA feedback on registration strategy for Blinatumomab in relapsed/refractory acute lymphoblastic leukemia (MITI) 5.69 : The plan incorporates advice received from the FDA within the context of a Type C meeting. "Recent feedback received from the FDA provides a roadmap to blinatumomab registration in a patient population with limited therapeutic options... We look forward to initiating later this quarter the first of two planned clinical trials collectively intended to support a biologics license application for full approval." Later this quarter, the Company plans to initiate a single-arm Phase 2 clinical study that will enroll approximately 65 adult patients with B-precursor r/r ALL. Co also reviewed with the FDA the preliminary design of a planned randomized, controlled, Phase 3 clinical study intended to evaluate the efficacy and safety of blinatumomab in comparison to chemotherapy in adult patients with r/r B-precursor ALL. Data from this trial, if positive, are intended to support full approval of blinatumomab in this patient population.