BeOne Medicines (SHA:688235, HKG:6160) said the U.S. Food and Drug Administration granted accelerated approval to Beqalzi to treat a type of rare blood cancer, according to a Thursday filing with the Hong Kong bourse.
The drug, also known as sonrotoclax, will be available for adult patients with relapsed or refractory mantle cell lymphoma who have failed at least two lines of system therapy.
Continued approval for this indication will remain contingent upon confirmation of clinical benefit in the ongoing trial of the medicine.
Beqalzi holds the breakthrough therapy, fast-track, and orphan drug designations in this indication, BeOne said.
Shares of the company were up over 2% in pre-market trade.