InnoCare Pharma announced that BTK inhibitor orelabrutinib has been granted priority review for the treatment of relapsed or refractory Marginal Zone Lymphoma (R/R MZL) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), which accepted the supplemental New Drug Application (sNDA) of orelabrutinib for the treatment of R/R MZL recently.
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said: “We are so inspired by this excited news. This is the third indication of orelabrutinib granted priority review. There are unmet medical needs for patients with R/R MZL. We hope orelabrutinib can bring better treatment options to benefit patients with R/R MZL.”
The sNDA of Orelabrutinib for the treatment of R/R MZL was accepted by the CDE on August 12. This NDA was submitted based on data from an open multi-center Phase II clinical study to investigate the safety and efficacy of orelabrutinib for the treatment of R/R MZL.
Current treatment options for R/R MZL are quite limited. So far, no BTK inhibitor has ever been approved for treating patients with R/R MZL in China, and hope that orelabrutinib can fill the gap in this therapeutic area.