RARE Daily

FDA Grants Fast Track Designation to Senhwa’s Silmitasertib to Treat Recurrent SHH Medulloblastoma

August 19, 2021

The U.S. Food and Drug Administration granted Fast Track designation for Senhwa Biosciences’ silmitasertib, a highly selective inhibitor of casein kinase 2, for the treatment of patients with recurrent sonic hedgehog driven medulloblastoma, a rare cancer.

Medulloblastoma is the most common cancerous brain tumor in children, but no targeted therapy is currently available. Symptoms associated with a medulloblastoma include headaches in the morning that improve as the day goes on, recurrent vomiting, and difficulty walking and with balance. Medulloblastomas can spread to other areas of the central nervous system. The exact cause of a medulloblastoma is unknown.

Fast Track Designation expedites the review of new drugs for serious conditions currently without effective treatments. Through Fast Track, Senhwa is eligible to apply for Accelerated Approval and Priority Review upon reaching relevant criteria with the FDA.

“We are delighted to receive Fast Track Designation and look forward to working closely with the FDA to accelerate the development of silmitasertib, aiming to promptly bring a meaningful treatment to patients with recurrent SHH driven medulloblastoma,” said Tai-Sen Soong, CEO of Senhwa Biosciences.

Silmitasertib is a first-in-class small molecule drug that targets the CK2 (casein kinase 2) pathway and acts as a CK2-inhibitor. It is safe and well-tolerated in humans and is easily administered due to its oral formulation.

Senhwa’s clinical partner, the Pediatric Brain Tumor Consortium, is currently conducting a phase 1/2 and Surgical Study of silmitasertib in both children and adults with recurrent SHH medulloblastoma. This study is taking place at the PBTC’s participating member academic medical centers and children’s hospitals across the United States. The PBTC is sponsoring this clinical trial and is funded through the Consortium grant awarded by the U.S. National Institutes of Health Cancer Therapy Evaluation Program (CTEP).

Silmitasertib was granted Rare Pediatric Disease designation for the treatment of medulloblastoma in July 2020. If certain criteria are met with the RPD designation, Senhwa is eligible for a transferrable Priority Review Voucher, which allows its recipient an expedited review process of any one of its new drug products from a ten-month to a six-month timeframe.

Photo: Tai-Sen Soong, CEO of Senhwa Biosciences

Author: Rare Daily Staff

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