AstraZeneca’s Calquence Combo Approved for First-Line CLL in EU

AstraZeneca's Calquence (acalabrutinib), in combination with venetoclax and with or without obinutuzumab, has received EU approval for first-line treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)5.

Calquence plus venetoclax is the first and only all-oral combination treatment with a second-generation BTK inhibitor approved for this indication in the EU35.

Approval was based on results from the Amplify phase 3 trial, which demonstrated that 77% of patients treated with Calquence plus venetoclax and 83% with Calquence plus venetoclax and obinutuzumab were progression-free at three years, outperforming the 67% progression-free rate with standard chemoimmunotherapy5.

The new approval offers a fixed-duration treatment option, providing more flexibility for patients and clinicians in managing CLL, which is the most common type of leukaemia in adults5.

Regulatory applications for these regimens are under review in several other countries as well, based on the same Amplify trial data5.

Sources:

3. https://firstwordpharma.com/story/5970237

5. https://www.morningstar.co.uk/uk/news/AN_1749196947332567100/astrazenecas-calquence-gets-eu-nod-to-treat-adults-with-leukaemia.aspx