AstraZeneca says Imfinzi granted breakthrough therapy designation by FDA
AstraZeneca and MedImmune, its global biologics research and development arm, announced that the FDA has granted Breakthrough Therapy Designation for IMFINZI, an anti-PD-L1 monoclonal antibody, being investigated for the treatment of patients with locally advanced, unresectable non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy. The Breakthrough Therapy Designation for durvalumab was granted on the basis of interim results from the Phase III PACIFIC trial, a randomized, double-blinded, placebo-controlled multi-center trial of durvalumab as sequential treatment in patients with locally-advanced, unresectable NSCLC who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy. This achievement is the fourth Breakthrough Therapy Designation AstraZeneca has received from the FDA for medicines in Oncology over the past three years and the second for durvalumab. In May 2017, AstraZeneca received accelerated approval from the FDA for IMFINZI for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before or after surgery. IMFINZI is approved under the FDA's accelerated approval pathway, based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Data from the PACIFIC trial have been submitted for presentation at a forthcoming medical meeting. Durvalumab is also being tested in for the treatment of NSCLC in the adjuvant setting in the ADJUVANT Phase III trial. In the Stage IV 1st-line setting for patients with advanced NSCLC, durvalumab as monotherapy and in combination with tremelimumab, an anti-CTLA-4 monoclonal antibody, is being tested in the MYSTIC, NEPTUNE and PEARL Phase III trials. The POSEIDON trial is evaluating durvalumab with and without tremelimumab in combination with chemotherapy.