FDA approves new indication for leukemia drug


Approval made via international collaborative effort.

FDA approved

FDA granted a supplemental approval to acalabrutinib (Calquence, AstraZeneca) to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

FDA made the approval as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada. Project Orbis “provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international partners,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a statement from FDA.

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“We are pleased to continue working alongside our Australian and Canadian colleagues to facilitate new treatment options for patients and the FDA looks forward to working with other countries in future application reviews,” Pazdur added.

The new indication for Calquence provides a new treatment option for patients with CLL or SLL as an initial or subsequent therapy.

“With over 20,000 new cases anticipated this year in the U.S. alone, today’s approval of Calquence provides new hope for patients with one of the most common types of adult leukaemia, offering outstanding efficacy and a favorable tolerability profile. The chronic lymphocytic leukaemia patient population is known to face multiple comorbidities, and tolerability is a critical factor in their treatment,” said Dave Fredrickson, executive vice president of AstraZeneca’s Oncology Business Unit, in a statement from AstraZeneca.

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The supplemental approval of Calquence for patients with CLL or SLL was based on two randomized clinical trials that compared Calquence to other standard treatments. In the first trial involving 535 patients with previously untreated CLL, patients receiving Calquence had a longer progression-free survival (the amount of time a patient stays alive without the cancer growing) compared to patients receiving other standard treatments.

The second clinical trial involving 310 patients with previously treated CLL also showed that Calquence had a longer progression-free survival than patients receiving other standard treatments.

In addition to the international collaboration with Australia and Canada, FDA’s review used its Real-Time Oncology Review (RTOR) pilot program, which can streamline the submission of data prior to the completion and submission of the entire clinical application, the agency said.


FDA also granted the application priority review and breakthrough therapy designation.

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