publication date: Nov. 22, 2019

Drugs & Targets

FDA takes second action under international collaboration, approving treatment option for CLL or SLL

As part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, FDA granted supplemental approval to Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. This new approved indication for Calquence provides a new treatment option for patients with CLL or SLL as an initial or subsequent therapy.

The approval was announced Nov. 21. Calquence is sponsored by AstraZeneca.

“Today, as part of a U.S., Australian and Canadian collaboration known as Project Orbis, the U.S. approved a new treatment option for those living with chronic lymphocytic leukemia or small lymphocytic lymphoma. The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international partners,” Richard Pazdur, 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, said in a statement. “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.”

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. The first clinical trial involved 535 patients with previously untreated CLL. Patients receiving Calquence had a longer progression-free survival compared to patients receiving other standard treatments. The second clinical trial included 310 patients with previously treated CLL. Patients receiving Calquence also had a longer progression-free survival than patients receiving other standard treatments.

In addition … Continue reading FDA takes second action under international collaboration, approving treatment option for CLL or SLL

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