AstraZeneca's blood cancer drug Calquence gets conditional approval in China
Roland Magnusson

China' National Medical Products Administration (NMPA) granted conditional approval to AstraZeneca's (NASDAQ:AZN) Calquence to treat adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
The British pharma giant said this the first approved indication for Calquence (acalabrutinib) â a next generation, selective Bruton's tyrosine kinase (BTK) inhibitor â in China.
The conditional approval was backed by data from two trials, a global Phase 2 trial, dubbed ACE-LY-004, in adults with relapsed or refractory MCL and a phase 1/ 2 study in Chinese patients with relapsed or refractory MCL and other B-cell malignancies.
AstraZeneca noted that continued approval of the drug for this use may depend on verification of ongoing randomized controlled confirmatory trials.
MCL is a rare form of non-Hodgkin lymphoma (NHL). NHL is a type of cancer which starts in the lymphatic system. In NHL white blood cells called lymphocytes grow abnormally.
"This approval for Calquence offers people living with mantle cell lymphoma in China an effective and tolerable new treatment option to help control their disease," said Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca.
Calquence is approved to treat certain patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in the U.S. and Japan and for certain patients with CLL in the EU. The drug is also approved in the U.S. and several other countries to treat certain adults with MCL. However, Calquence is not currently approved to treat MCL in Japan or the EU, according to the company.
In February, the tablet formulation of Calquence to treat certain adult patients with CLL was approved in the EU.
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