FDA grants priority review to acalabrutinib for mantle cell lymphoma

The FDA granted priority review to acalabrutinib for the treatment of patients with previously treated mantle cell lymphoma, according to the drug’s manufacturer.

The announcement comes a day after the FDA granted breakthrough therapy designation to acalabrutinib (ACP-196, AstraZeneca), a highly selective, potent Bruton’s tyrosine kinase inhibitor.

“The FDA’s acceptance of the acalabrutinib application and priority review illustrates the impact it could have on patients with relapsed or refractory mantle cell lymphoma as we work to bring this potential medicine to those in need as quickly as possible,” Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in a company-issued press release.

AstraZeneca’s new drug application included results from the phase 2 ACE-LY-004 clinical trial, designed to evaluate the efficacy and safety of acalabrutinib for patients with relapsed or refractory mantle cell lymphoma.

The FDA set a Prescription Drug User Fee Act date for the first quarter of next year.

“We believe acalabrutinib has the potential to be a very important treatment option for patients with this life-threatening blood cancer,” Flavia Borellini, PhD, CEO of Acerta Pharma — AstraZeneca’s hematology research and development center of excellence — said in the release. “The FDA’s new drug application acceptance exemplifies our progress in the acalabrutinib development program and continues our momentum as we seek to transform care for people with hematologic malignancies.”