AstraZeneca Plc. AZN announced that the FDA has granted a priority review to a supplemental biologics license application (sBLA) seeking approval for a less-frequent, fixed-dose regimen of Imfinzi for its approved indications. Imfinzi is presently approved to treat stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy and previously treated advanced bladder cancer.
The FDA has set an action date inthe fourth quarter of 2020.
The FDA generally grants a priority review to drugs with the potential to treat a serious condition and if approved, would substantially improve safety or effectiveness.
If approved Imfinzi could be administered intravenously every four weeks at a fixed dose of 1500 mg. The new dosing would be available as an alternative to the approved weight-based dosing of 10mg/kg every two weeks. The new less-frequent dosing option, if approved, will be a simplified option and also reduce risk of exposure to infection as the number of visits by patients will be reduced by half. Hence, their chances of getting infected will also be reduced.
This year so far, AstraZeneca’s shares have risen 13% compared with the industry’s growth of 1.9%.
Other than the approved indications in NSCLC and bladder cancer, the FDA also granted approval to Imfinzi in March for the first-line treatment of extensive-stage small cell lung cancer —the most aggressive type of lung cancer.
Imfinzi contributed $954 million of revenues in the first half of 2020, representing growth of about 51% year over year and contributing about 8% of total product sales of the company.
Imfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.
However, other companies having PD-L1 inhibitors, which makes the market for Imfinzi competitive, areMerck’s MRK Keytruda, Bristol-Myers’ BMY Opdivo and Roche’s RHHBY Tecentriq. Several other pharma companies are also developing immunotherapies in different stages in clinical studies.
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