The U.S. Food and Drug Administration (FDA) has accepted and given priority review to AstraZeneca‘s application requesting a new dosing regimen for Imfinzi (durvalumab) to treat certain non-small cell lung cancer (NSCLC) and bladder cancer patients.
If approved, Imfinzi could be administered at a fixed dose of 1,500 mg every four weeks, an alternative to the weight-based dosing of 10 mg/kg every two weeks now set for these two indications. A similar once monthly, fixed dose regimen is approved for advanced (extensive stage) small cell lung cancer.
A decision is expected before year’s end.
“The new less-frequent dosing option for non-small cell lung cancer and bladder cancer will simplify and improve treatment by enabling continuity of care while minimizing the risk of exposure to infection in the healthcare setting,” Dave Fredrickson, AstraZeneca’s executive vice president, said in a press release.
“This takes on particular urgency during the current pandemic, as doctors care for patients at high risk of COVID-19 complications. We are working with health authorities in the US and other countries to bring the option of four-week, fixed dosing for Imfinzi to patients around the world as soon as we can,” Fredrickson added.
Imfinzi is an immune checkpoint inhibitor designed to harness the immune response by blocking PD-L1, a protein involved in mechanisms used by cancer cells to evade immune system attack.
The treatment is approved in the U.S. for people with inoperable, locally advanced NSCLC after chemotherapy and radiation, for those with previously treated advanced bladder cancer, and as a first-line treatment for extensive-stage small cell lung cancer.
Unlike patients with this form of lung cancer, however, the approved regimen for NSCLC and bladder cancer patients is a 10 mg/kg dose every two weeks. This requires more frequent hospital or clinic visits, as Imfinzi is given by intravenous infusion over 60 minutes.
AstraZeneca’s supplemental biologics license application (sBLA) asks that the fixed dose regimen be approved for this treatment’s other two cancer indications. It is based on data from several clinical trials, including the CASPIAN Phase 3 trial (NCT03043872) that used the four-week, fixed-dosed regimen. CASPIAN also provided the basis for Imfinzi’s approval, with standard chemotherapy, as an initial treatment of patients whose small cell lung cancer has spread in the lungs or elsewhere.
Under priority review, the FDA review will take place within a six-month period, as opposed to the more standard 10 months. The FDA has set their Prescription Drug User Fee Act date for the fourth quarter of 2020.
The FDA grants priority review to investigational medicines that might offer significant advances over available therapies by improving safety or efficacy, preventing serious conditions, or enhancing patient compliance.
