FDA Approves Less Frequent Treatment Regimen for Imfinzi in NSCLC, Bladder Cancer

FDA Approves Less Frequent Treatment Regimen for Imfinzi in NSCLC, Bladder Cancer

The U.S. Food and Drug Administration (FDA) has approved a new dosing regimen for Imfinzi (durvalumab) for the treatment of certain non-small cell lung cancer (NSCLC) and bladder cancer patients.

Granted under priority review, the approval allows Imfinzi to be administered at a fixed dose of 1,500 mg every four weeks for patients weighing more than 30 kg (about 66 pounds). It is an alternative to the weight-based dosing of 10 mg/kg every two weeks previously set for these two indications.

A similar fixed-dose regimen administered once a month was already approved for advanced (extensive stage) small cell lung cancer (ES-SCLC). This regimen requires fewer hospital or clinic visits, and reduces exposure to hospital infections, which is particularly important during the COVID-19 pandemic.

“This new four-week dosing option gives doctors the choice to cut the number of visits for critical cancer treatment in half and offers a regimen that is more convenient for patients,” Victoria M. Villaflor, MD, professor at the City of Hope Cancer Center in California, said in a press release.

“Additionally, it limits potential exposure to infection in the healthcare environment for a population that is especially vulnerable to complications from COVID-19,” Villaflor added.

Imfinzi, marketed by AstraZeneca, is an immune checkpoint inhibitor that works by blocking PD-L1, a protein used by cancer cells to evade immune responses. Blocking PD-L1 allows the immune system to target and kill cancer cells more effectively.

In the U.S., Imfinzi is approved for certain NSCLC, ES-SCLC, and bladder cancers. But while ES-SCLC patients receive the medication via a monthly infusion, the approved administration for those with NSCLC and bladder cancer was every two weeks.

The new approval now makes Imfinzi available as a once-a-month infusion for all of its indications.

The decision was based on data from several clinical trials, including the Phase 3 CASPIAN trial (NCT03043872), in which Imfinzi was administered as a four-week, fixed-dosed regimen to ES-SCLC patients, and the PACIFIC Phase 3 trial (NCT02125461), in which NSCLC patients received the two-week dosing regimen.

“The approval of this new dosing option across indications reflects our ongoing commitment to improve the patient experience and ensure continuity of care — a priority at all times, but especially during the pandemic,” said Dave Fredrickson, AstraZeneca’s executive vice president.

“Cancer won’t wait, and it is our job to provide patients with treatment options that acknowledge the challenges the pandemic poses to cancer care, enabling them to visit their physician when truly needed and avoid preventable exposure to healthcare-associated infections,” he added.

The new dosing regimen is also under review in several countries, including in the European Union, where AstraZeneca’s application was granted accelerated assessment.