Folotyn (Pralatrexate) Receives FDA Approval Global Update

Folotyn (generic name: Pralatrexate), the first drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL), has made a number of important advances worldwide since its launch in 2009.

Folotyn Launch Of Generic Drugs

In December 2022, Fresenius Kabi launched a generic version of Platuxa Injection in the US market, providing additional treatment options for patients with relapsed or refractory PTCL.

Application And Rollout In China

In January 2022, CASI Pharmaceuticals (CASI Pharmaceuticals) successfully completed the first case of Folotyn administration to a patient with PTCL in China, marking an important step in the clinical application of the drug in China.

In August 2023, Kaixin Yuanda Pharmaceuticals secured commercialisation rights for Folotyn in China by entering into an agreement with Mundipharma International Corporation Limited, Mundipharma Medical Company and Acrotech Biopharma Inc. which further boosted the drug’s market accessibility in China.

FDA Accelerated Approval Programme Review

However, Folotyn’s accelerated approval has also raised industry concerns about delays in its confirmatory trials.

During its review, the FDA’s Oncology Drug Advisory Committee (ODAC) questioned the development process for Folotyn and another drug, belinostat, highlighting the importance of confirmatory trials.

Clinical And Safety Profile Of Pralatrexate

Folotyn Pralatrexate remains a dihydrofolate reductase inhibitor with a well-documented efficacy and safety profile:

• Dosing: 30 mg/m² weekly for 6 weeks (7-week cycles).
• Common side effects: Mucositis, thrombocytopenia, nausea, and fatigue (>35% incidence).
• Serious risks: Myelosuppression, severe skin reactions, and tumor lysis syndrome.

The drug’s accelerated approval was based on a single-arm study (ORR: 27%), but full approval hinges on confirmatory data.

Future Outlook: Will Folotyn Maintain Its Role In PTCL Treatment?

As generic competition grows and regulatory pressures mount, Folotyn’s future will depend on:

• Timely completion of confirmatory trials to solidify its clinical benefits613.
• Market competition from biosimilars and newer PTCL therapies.
• Expansion in emerging markets, such as China, where CASI is driving adoption1.

For now, Folotyn remains a vital option for relapsed/refractory PTCL patients, but its long-term standing will hinge on resolving ongoing regulatory and clinical challenges.

However, HK DengYue’s efforts to increase the affordability of the medicine are critical to ensuring that more patients benefit from it.

We welcome you to reach out to us to buy Pralatrexate. DengYueMedicine is here to provide detailed medicine information, pricing, and support to ensure a smooth and reliable buying experience.

Feel free to contact us anytime to discuss your needs or ask any questions about the medicine.

Information from DengYueMed, China Drug Import and Export Wholesaler offers this information as a guide, not a substitute for professional medical advice. Consult your doctor before any treatment.