FDA grants breakthrough therapy designation to orelabrutinib for mantle cell lymphoma
The FDA granted breakthrough therapy designation to orelabrutinib for the treatment of patients with relapsed or refractory mantle cell lymphoma, according to a manufacturer-issued press release.
Orelabrutinib (InnoCare Pharma) is a highly selective Bruton tyrosine kinase inhibitor under investigation for B-cell malignancies and autoimmune diseases. It has been approved by the China National Medical Products Administration for patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma and patients with relapsed or refractory mantle cell lymphoma.
“We are very proud that orelabrutinib was granted breakthrough therapy designation after obtaining orphan drug designation,” Jasmine Cui, PhD, co-founder, chairwoman and CEO of InnoCare Pharma, said in the release. “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."
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