AstraZeneca's BTK Inhibitor Acalabrutinib (Calquence) Granted New Indication in China for Relapsed or Refractory CLL/SLL

On September 1, the information on the delivery of drug approval certificates released by the National Medical Products Administration of China showed that AstraZeneca's BTK inhibitor Calquence (Acalabrutinib) has been approved for a new indication as a monotherapy for adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have previously received at least one treatment. Previously, this drug was approved in China in March this year for adult patients with mantle cell lymphoma (MCL) who have previously received at least one treatment.

Acalabrutinib is a second-generation BTK inhibitor that can covalently bind to BTK and inhibit its activity.

In October 2017, acalabrutinib capsules received accelerated approval from the U.S. FDA for patients with mantle cell lymphoma (MCL) who had received at least one prior treatment, under the brand name Calquence. In November 2019, acalabrutinib capsules were approved by the FDA for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). In August 2022, AstraZeneca launched acalabrutinib tablets in the United States for all approved indications, including MCL, CLL, and SLL.

Currently, there are six BTK products available on the global market: Ibrutinib (Imbruvica) by Johnson & Johnson/AbbVie, Acalabrutinib (Calquence) by AstraZeneca, Zanubrutinib (Brukinsa) by BeiGene, Tirabrutinib (Velexbru) by Ono Pharmaceutical, Orelabrutinib (Kemvlix) by InnoCare Pharma, and Pirtobrutinib (Jaypirca) by Eli Lilly.

Editor: Liuli

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