ARTICLE | Clinical News

FDA approves AZ's Btk inhibitor Calquence for MCL

November 3, 2017 4:51 AM UTC

FDA granted accelerated approval to Calquence acalabrutinib (formerly ACP-196) from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Acerta Pharma B.V. (Oss, the Netherlands) to treat mantle cell lymphoma in adults who have received ≥1 prior therapy. The approval came ahead of the drug's PDUFA date in 1Q18. The second-generation Bruton's tyrosine kinase (Btk) inhibitor has breakthrough therapy and Orphan Drug status in the U.S. to treat MCL.

AZ spokesperson Stephanie Wiswall said Calquence is immediately available to U.S. patients at a wholesale acquisition cost (WAC) of $14,259 for a 1-month supply...