Global launch progress of acotinib/acalabrutinib

Acalabrutinib (Acalabrutinib), also widely known as acalabrutinib or ACP-196, is a highly effective Bruton tyrosine kinase (BTK) inhibitor developed by AstraZeneca. The drug has shown significant efficacy in adults with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL) who have undergone one or more lines of therapy.

In the United States, the Food and Drug Administration (FDA) officially approved the marketing of acotinib oral capsules in October 2017. In August 2022, the FDA further approved a new acotinib tablet. The combined use of this new dosage form with proton pump inhibitors (PPIs) will not have a negative impact on the pharmacokinetics of acotinib, thus providing a more flexible treatment option.

In Europe, acotinib was designated as an orphan drug by the Committee for Orphan Medicines (COMP) of the European Medicines Agency (EMA) in November 2020. This designation is based on the drug's obvious efficacy in the treatment of CLL. Acotinib has demonstrated its clinical advantages whether used alone or in combination with obinutuzumab in trials. In addition, its side effects are within the acceptable range and are not significantly different from other similar drugs.

It is worth mentioning that acotinib has also made important progress in the Chinese market. In August 2023, the State Food and Drug Administration approved the marketing of acotinib oral capsules, and the drug has passed the relevant policies of the National Medical Insurance Bureau and been included in the reimbursement scope of Class B medical insurance. This move will undoubtedly greatly reduce the financial burden on patients and enable more MCL patients to benefit from the treatment of this innovative drug.