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FDA approves less-frequent dose of durvalumab


The new fixed-dose schedule is approved for all of durvalumab's FDA indications, including advanced bladder cancer.

The FDA has approved a less-frequent, fixed-dose regimen of durvalumab (Imfinzi) for all of its approved indications, including previously treated advanced bladder cancer, according to AstraZeneca, the developer of the PD-L1 inhibitor.1

Durvalumab is now approved for a dosing schedule of 1500 mg every 4 weeks. Previously approved regimens require patients to received treatment every 2 weeks. The approval was based on several clinical trials of durvalumab, including the phase 3 PACIFIC trial in non–small cell lung cancer (NSCLC) and the phase 3 CASPIAN trial in extensive-stage small cell lung cancer (ES-SCLC)

“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. Additionally, it limits potential exposure to infection in the healthcare environment for a population that is especially vulnerable to complications from COVID-19,” Victoria M. Villaflor, MD, clinical professor in the Department of Medical Oncology and Therapeutics Research at City of Hope Cancer Center, Los Angeles, California, stated in a press release.

In bladder cancer, durvalumab is approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

The FDA granted durvalumab an accelerated approval for this indication in May 2017 based on the single-arm phase I/II Study 1108, which included 182 patients with locally advanced or metastatic urothelial carcinoma who experienced disease progression following platinum-containing chemotherapy.2

In the study, the objective response rate (ORR) per blinded independent central review was 17.0%. At the data cutoff, the median duration of response was not reached (range, 0.9+ to 19.9+ months).

Among 95 patients with high PD-L1 expression, the ORR was 26.3%. In the cohort of 73 patients with low or no PD-L1 expression, the ORR was 4.1%.

As an accelerated approval, the continued approval for durvalumab in this indication is contingent on the results of a confirmatory phase 3 trial.

In NSCLC, durvalumab is approved for the treatment of patients with unresectable stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. In ES-SCLC, durvalumab is approved for use in combination with etoposide and either carboplatin or cisplatin as first-line treatment.

"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. 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.” Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca, stated in the press release.


1. Imfinzi approved in the US for less-frequent, fixed-dose use. Posted November 20, 2020. https://bit.ly/3lSMKMg. Accessed November 20, 2020.

2. Durvalumab (Imfinzi). FDA. Posted May 1, 2017. https://bit.ly/3nG6MKp. Accessed November 20, 2020.

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