Baizensel Applies for MFDS Fast-Track Designation of NK/T-Cell Lymphoma Treatment
T-cell Therapy Targeting EBV-Positive NK/T-Cell Lymphoma
Baizensel has initiated the expedited development and approval procedures for its NK/T-cell lymphoma treatment, VT-EBV-N.
On July 2, Baizensel announced that it has applied to the Ministry of Food and Drug Safety (MFDS) for designation of VT-EBV-N, a treatment for EBV (Epstein-Barr virus)-positive extra-nodal NK/T-cell lymphoma, as a fast-track advanced biopharmaceutical product.
VT-EBV-N is an EBV antigen-specific T-cell therapy currently under development for EBV-positive extra-nodal NK/T-cell lymphoma, a rare hematologic cancer with a high recurrence rate. In 2019, the MFDS designated it as an orphan drug for development purposes. Baizensel has now applied for this designation based on the results from its Phase 2 clinical trials.
If designated as a fast-track advanced biopharmaceutical product, the treatment will be eligible for tailored consultations and expedited review by the MFDS. If linked to the Global Innovative Product Fast-track (GIFT) review system, the review period can be reduced by up to 25% compared to standard reviews. Baizensel plans to prepare for the product approval application for VT-EBV-N according to the MFDS review results and related procedures after the fast-track designation is granted.
Baizensel CEO Pyeongseok Ki stated, “We are focusing on preparing for the commercialization of VT-EBV-N to provide new treatment options for NK/T-cell lymphoma patients with high unmet medical needs. We will strictly comply with regulatory guidelines to ensure a thorough new drug approval process and strive to make this a meaningful case for the domestic advanced biopharmaceutical industry.”
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Recently, VT-EBV-N was selected for oral presentation at both the American Society of Clinical Oncology (ASCO) and the European Hematology Association (EHA). In addition, it became the first product in Korea to receive approval from the Ministry of Health and Welfare as an appropriate therapy for advanced regenerative medicine.
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