The drug received accelerated approval in October 2017 as monotherapy for adults with MCL who have received at least one ...

Approval follows results from the Phase III ECHO trial, which demonstrated that Calquence plus chemotherapy reduced the risk ...

The FDA approved two oncology regimens on Jan. 16.One is for a subset of patients with colorectal cancer and the other for ...

The new first-line MCL indication gives Calquence a slice of the market of its own and could spur further growth of the drug, ...

The Food and Drug Administration has granted traditional approval to Calquence with bendamustine and Rituxan for some ...

The approval of Calquence marks the first and only BTK inhibitor approved for the first-line treatment of MCL in the US.

AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma ...

MB-105, a first-in-class CD5-targeted CAR T-cell therapy, received FDA orphan drug designation for relapsed/refractory T-cell ...

for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. This decision, announced today ...

AstraZeneca’s (AZ) Calquence (acalabrutinib) has been approved by the US Food and Drug Administration (FDA) as part of a ...