FDA grants accelerated approval toCalquence (ACP 196) to treat mantle cell lymphoma.- AstraZeneca

AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, announced that the FDA has granted accelerated approval to Calquence (acalabrutinib). Calquence is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Calquence is approved under the FDA’s accelerated approval pathway, based on overall response rate, which allows for earlier approval of medicines that treat serious conditions and that fill an unmet medical need based on a surrogate endpoint. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Approval of Calquence was based on data from a single-arm trial that included 124 patients with mantle cell lymphoma who had received at least one prior treatment. The trial measured how many patients experienced complete or partial shrinkage of their tumors after treatment (overall response rate). In the trial, 81 percent of patients had a complete or partial response (40 percent complete response, 41 percent partial response).

Comment:The Prescription Drug User Fee Act (PDUFA) date was during the first quarter of 2018..