BRIEF—Calquence gains first regulatory approval in China

AstraZeneca’s next generation, selective Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) has been conditionally approved in China for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

This is the first approved indication for Calquence in China, the UK pharma major noted.

The conditional approval by the National Medical Products Administration (NMPA) was based on positive results from two clinical trials, including the ACE-LY-004 global Phase II trial in adults with relapsed or refractory MCL and a Phase I/ II trial in Chinese patients with relapsed or refractory MCL and other B-cell malignancies.#

Continued approval for this indication may be contingent upon verification of ongoing randomised controlled confirmatory trials.

MCL is typically an aggressive, rare form of non-Hodgkin lymphoma (NHL) that accounts for between 2% and 6% of all patients diagnosed with NHL in China.

Patients are generally diagnosed around 60 years of age, often at later stages of the disease.