FDA Approves Additional Dosing Option of Durvalumab for Stage III NSCLC, Advanced Bladder Cancer

The FDA has approved an additional dosing option of durvalumab (Imfinzi): a 1500 mg fixed dose administered every 4 weeks for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy (CRT) and previously treated advanced bladder cancer, according to AstraZeneca, the developer of the agent.

This new option is consistent with the approved durvalumab dosing in extensive-stage small cell lung cancer (ES-SCLC) and will be available for patients weighing more than 30 kg as an alternative to the already approved weight-based dosing of 10 mg/kg every 2 weeks.

“This new 4-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, clinical professor in the department of Medical Oncology and Therapeutics Research at City of Hope Cancer Center, 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.”

Prior to approval of durvalumab in this setting, no new treatments outside of CRT had been available to patients for decades.

The approval of the new dosing regimen was based on data from several clinical trials of durvalumab, including the phase 3 PACIFIC trial which supported the 2-week, weight-based dosing in unresectable stage III NSCLC, and the phase 3 CASPIAN trial which used 4-week, fixed-dosing during maintenance treatment in ES-SCLC. This decision follows the priority review granted by the FDA in August 2020.

Of note, the 4-week 1500 mg fixed-dosing option for durvalumab is also under regulatory review in several other countries, including in the EU where the new dosing option was granted accelerated assessment.

Currently, durvalumab is approved in the curative-intent setting of unresectable, stage III NSCLC after CRT in the US, EU, Japan, China, and many other countries. Durvalumab is also approved for previously treated patients with advanced bladder cancer in the US and several other countries. In addition, it is approved in the US, the EU, Japan, and several other countries around the world for the treatment of ES-SCLC.

Reference:

Imfinzi approved in the US for less-frequent, fixed-dose use [news release]. Published November 20, 2020. Accessed November 20, 2020. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/imfinzi-new-dosing-approved-in-the-us.html