AstraZeneca and MedImmune announced that Imfinzi (durvalumab) has been designated Breakthrough Therapy by the Food and Drug Administration (FDA) for locally-advanced, unresectable non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after platinum-based chemoradiation therapy.

Interim data from the Phase 3 randomized, double-blinded, placebo-controlled, multicenter PACIFIC trial supported the Breakthrough Therapy designation. The study’s primary endpoints were progression-free survival (PFS) and overall survival (OS); secondary endpoints included landmark PFS and OS, objective response rate (ORR) and duration of response. Findings from PACIFIC have been submitted for an upcoming medical meeting. Imfinzi is also being investigated as adjuvant treatment of NSCLC in the Phase 3 ADJUVANT trial. 

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Imfinzi, an anti-PD-L1 monoclonal antibody, was previously granted accelerated approval from the FDA for locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions releases the inhibition of immune responses, without inducing antibody dependent cell-mediated cytotoxicity (ADCC). 

“Imfinzi is the first immuno-oncology medicine to show a clinically significant benefit in this earlier, non-metastatic setting, so following Breakthrough Designation we hope to bring it to patients as soon as possible,” commented Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca.

Imfinzi is available as 500mg/10mL or 120mg/2.4mL strengths in single-dose vials.

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