Is acotinib/acalabrutinib on the market?

As of October 2017, the U.S. Food and Drug Administration (FDA) approved AstraZeneca’s oral acotinib capsules. This Bruton tyrosine kinase (BTK) inhibitor is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL) who have received at least one prior therapy. In August 2022, the FDA approved a new acotinib tablet, allowing the drug to be used in combination with proton pump inhibitors (PPIs). Unlike capsules, coadministration of tablets with PPIs does not affect the pharmacokinetics of acotinib.

In November 2020, acotinib was also designated as an orphan drug by the Committee for Orphan Medicines (COMP) of the European Medicines Agency (EMA). In patients with CLL, acotinib has shown significant benefits, both when used alone and in patients who have not previously received obinutuzumab. The results are considered clinically relevant, and although the studies involved older patients and those with other medical conditions, the results may also apply to younger and healthier patients. The side effects of this drug are considered acceptable and consistent with those of other drugs that work in the same way.

Acotinib is also known asACP-196, and is also considered a second-generation BTK inhibitor. In the Chinese market, the original drug acotinib was approved by the National Medical Products Administration in August 2023 in the form of oral capsules. It also passed the relevant policies of the National Medical Insurance Administration and entered the scope of Class B medical insurance reimbursement. It is used to treat adult patients with mantle cell lymphoma (MCL) who have received at least one treatment in the past.