AstraZeneca's Calquence receives European Commission approval

(Sharecast News) - Drugmaker AstraZeneca said on Friday that it had received approval from the European Commission for fixed-duration regimens of its chronic lymphocytic leukaemia candidate Calquence in a first-line setting. AstraZeneca noted that the approval of Calquence, in combination with venetoclax, follows the positive opinion of the Committee for Medicinal Products for Human Use and was based on positive results from its pivotal AMPLIFY Phase III trial.

Results from the AMPLIFY trial showed that 77% of patients treated with Calquence plus venetoclax and 83% of patients treated with Calquence plus venetoclax and obinutuzumab were progression-free at three years, versus 67% of patients treated with standard-of-care chemoimmunotherapy.

However, AZN noted that median progression-free survival was not reached for either experimental arm, versus 47.6 months for chemoimmunotherapy.

Dave Fredrickson, executive vice president of AZN's oncology haematology business, said: "Today's approval brings a new fixed-duration treatment option to patients with previously untreated chronic lymphocytic leukaemia across Europe.

"Calquence plus venetoclax is the first and only all-oral combination treatment option with a second-generation BTK inhibitor approved in the EU and provides patients and their physicians more flexibility in managing this incurable blood cancer."

As of 0740 BST, AstraZeneca shares were untraded at 10,694.0p.

Reporting by Iain Gilbert at Sharecast.com