Rhizen Pharma receives FDA Fast Track Designation for RP6530

Rhizen Pharma receives FDA Fast Track Designation for RP6530

 

Alembic Pharma announced that Rhizen Pharmaceuticals S.A.,said the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for RP6530 (tenalisib), the Company’s highly selective and orally active dual PI3K delta/gamma inhibitor, for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL).

“We are pleased that RP6530 (tenalisib) has been granted Fast Track Designation, demonstrating the FDA’s commitment to facilitate the development and expedite the review of our highly selective and orally active dual PI3K delta/gamma inhibitor as an important therapy for patients with relapsed/refractory peripheral T-cell lymphoma (R/R PTCL),” said Swaroop Vakkalanka, Ph.D., Founder & President of Rhizen Pharmaceuticals S.A.