US-based biopharmaceutical company CASI Pharmaceuticals has administered the first dose of FOLOTYN (pralatrexate) to a patient with PTCL in China.
Pralatrexate is a dihydrofolate reductase inhibitor indicated to treat relapsed or refractory PTCL.
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When compared with methotrexate, the drug is claimed to internalise effectively into tumour cells, which may translate to an increased anti-cancer effect.
Clinical studies have highlighted pralatrexate’s activity against PTCL, with a registrational study in China reporting an overall response rate (ORR) of 52% and a median progression-free survival (PFS) of 4.8 months.
This compares favourably to the PROPEL study in the US, which showed an ORR of 29% and a median PFS of 3.5 months.
Pralatrexate is currently approved to treat PTCL in the US, Japan and China.
Last month, CASI announced a strategic partnership with the China National Medicines Corporation (CNMC), which marked a key step in marketing FOLOTYN in China.
CNMC has secured sole distribution rights for the product, enhancing CASI’s commercialisation efforts in China.
CASI CEO Dr Wei-Wu He said: “The dosing of the first patient with FOLOTYN in China marks a significant achievement for CASI.
“It reflects our unwavering commitment to bringing advanced therapeutic options to patients, particularly in therapeutic areas with substantial unmet medical needs.
“This is a proud moment for our team and a step forward in our mission to transform patient care through innovation.”
Based in Rockville, Maryland, CASI focuses on developing and marketing new therapeutics and pharmaceutical products for various markets worldwide.
Last November, the company announced that its partner Juventas had received NMPA market approval for CNCT 19, a drug indicated to treat relapsed and refractory B-cell acute lymphoblastic leukaemia, in China.
CNCT 19 is a CD19 CAR-T cell therapy being jointly commercialised and marketed by CASI and Juventas.
