Orelabrutinib Receives Breakthrough Therapy Designation for Mantle Cell Lymphoma

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to the selective Bruton tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL).

 

This decision is based on results from a phase II trial (NCT04014205) evaluating the safety and efficacy of oral orelabrutinib in 80 patients with B-cell malignancies, including relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). At a median follow-up of 6.3 months (range = 0.4-13.7), 78 patients were evaluable for response, with an overall response rate of 88.5% (n=69). One patient achieved a complete response, while 39 had a partial response (PR) and 29 achieved PR with lymphocytosis. The six-month duration of response (DOR) rate was 89.8%. Median DOR was not yet reached. Disease control rate was 96.2%, with 7.7% of patients experiencing disease stability.

 

Common grade ≥3 adverse events were neutropenia, thrombocytopenia, and lung infections. At least one serious toxicity was reported in 31% of patients, including decreased platelet count (n=3), pneumonitis (n=2), pyrexia (n=2), and herpes zoster (n=1).

 

In December, orelabrutinib was approved by the China National Medical Products Administration for the treatment of patients with relapsed/refractory MCL and CLL/SLL.

Source: Pharmacy Times, June 29, 2021.