China-based InnoCare Pharma (HKG: 9969, SHA: 688428) announced that it has obtained regulatory approval from the National Medical Products Administration (NMPA) for a new indication of its Bruton’s tyrosine kinase (BTK) inhibitor Orelabrutinib. The therapy is now authorized as a first-line treatment for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
Orelabrutinib’s Approved Indications
Orelabrutinib has been approved for three indications in China. In addition to the newly approved first-line treatment for CLL/SLL, it has also been approved for the treatment of relapsed and refractory (R/R) CLL/SLL, R/R mantle cell lymphoma (R/R MCL), and R/R marginal zone lymphoma (R/R MZL). These indications are all covered in the National Reimbursement Drug List (NRDL).-Fineline Info & Tech
