R/R MCL Treatment Receives U.S. FDA Breakthrough Therapy Designation
InnoCare Pharma announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Therapy Designation (BTD) to its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of relapsed or refractory mantle cell lymphoma (R/R MCL).
Orelabrutinib is a highly selective BTK inhibitor targeting both B-cell malignancy and autoimmune diseases.
Dr. Jasmine Cui, the co-founder, chairwoman, and CEO of InnoCare, said in a press release issued on June 28, 2021, “We are very proud that orelabrutinib was granted BTD after obtaining FDA Orphan Drug Designation."
"We will continue to uphold the concept of ‘Science drives innovation for the benefit of patients’ and accelerate clinical trials for multiple indications of orelabrutinib in China and the rest of the world to benefit patients worldwide.”
On December 25, 2020, orelabrutinib was approved by the China National Medical Products Administration in two indications: the treatment of patients with R/R CLL / small lymphocytic lymphoma and the treatment of patients with R/R MCL.