AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, said the FDA has granted accelerated approval to Calquence (acalabrutinib, previously known as ACP-196), a kinase inhibitor, for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
Last week, Richard Pazdur was named to the position of director of FDA’s Center for Drug Evaluation and Research. Much has been written about how Pazdur, with nearly a three-decade long career at the agency, represents a stabilizing choice for FDA as it faces inner and outer turmoil.
