AstraZeneca has secured US FDA approval for Calquence in combination with venetoclax as the first all-oral, fixed-duration regimen for treating adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma. The approval is based on the AMPLIFY Phase III trial, which demonstrated a 35% reduction in disease progression or death compared to standard chemoimmunotherapy.

Chronic lymphocytic leukemia affects an estimated 18,500 patients in the US first-line setting annually. The AMPLIFY trial showed that 77% of patients treated with Calquence plus venetoclax were progression-free at three years, compared to 67% for standard treatment. The combination also achieved a median progression-free survival that was not reached, versus 47.6 months for chemoimmunotherapy.

The treatment will be administered for a fixed duration of 14 cycles, with each cycle lasting 28 days. Calquence plus venetoclax is already approved in the European Union, Canada, UK and several other countries. Regulatory applications based on the AMPLIFY results are under review in additional markets, positioning AstraZeneca to expand its presence in the blood cancer treatment landscape.