Biotech | April 03, 2022
USFDA approves Yescarta as first CAR T-cell therapy for Lymphoma
Yescarta is First CAR T-cell therapy to receive NCCN treatment guideline category 1 recommendation --
Yescarta is First CAR T-cell therapy to receive NCCN treatment guideline category 1 recommendation --
Recommendation is based on pivotal data from the phase III POLARIX study
This is the first CAR T cell therapy application filed for the second-line treatment of R/R LBCL in Japan
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials
A next-generation, cell-based immunotherapy, CAR-T therapy engineers a patient’s own immune cells to detect and destroy cancer
The decision follows compelling data from the AMPLIFY Phase III trial, demonstrating that 77% of patients receiving the Calquence-venetoclax combination were progression-free at three years
Under the deal, Uniphar will serve as LYMPHIR’s exclusive distribution partner across designated Western and Eastern European territories
Improvements were also seen in complete response rates, duration of response, and time to next treatment
The trial aims to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the combination therapy
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