AstraZeneca's Imfinzi Receives FDA Priority Review for Less-Frequent, Fixed-Dose Regimen

Today, AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for durvalumab (brand name Imfinzi) and granted it Priority Review status. This sBLA submission seeks to change the dosing regimen of durvalumab from the previous weight-based dose of 10 mg/kg administered every two weeks to a fixed dose of 1,500 mg administered every four weeks. The updated regimen is intended for the treatment of patients with unresectable non-small cell lung cancer (NSCLC) following chemoradiotherapy and patients with previously treated advanced bladder cancer. This new regimen halves the number of treatments required, offering greater convenience for patients. Particularly during the COVID-19 pandemic, this new dosing schedule reduces the frequency of hospital visits for treatment, thereby lowering patients’ risk of viral infection.

This sBLA is based on data from multiple clinical trials of durvalumab, including the results from the Phase 3 CASPIAN trial in patients with extensive-stage small cell lung cancer (ES-SCLC), which evaluated a fixed-dose regimen administered once every 4 weeks during maintenance therapy.

Durvalumab is a humanized PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80, thereby inhibiting tumor immune escape and releasing suppressed immune responses. Based on the results of the phase 3 PACIFIC trial, durvalumab has been approved in the United States, Japan, China, the European Union, and many other countries and regions for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) following chemoradiotherapy. In the United States and several other countries, durvalumab is also approved for the treatment of patients with advanced bladder cancer who have previously received therapy. Additionally, it has been approved in the United States for the treatment of extensive-stage small cell lung cancer (ES-SCLC).

References:

[1] Imfinzi granted FDA Priority Review for less-frequent,

fixed-dose use. Retrieved August 18, 2020, from https://www.astrazeneca.com/media-centre/press-releases/2020/imfinzi-granted-fda-priority-review-for-less-frequent-fixed-dose-use.html

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