Senhwa's Silmitasertib Receives US FDA Fast Track Designation

19 August 2021 | Thursday | News

For the Treatment of Recurrent Sonic Hedgehog Driven Medulloblastoma
Image Source : Public Domain

Image Source : Public Domain

Senhwa Biosciences, Inc., a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, today announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for Silmitasertib, a highly selective inhibitor of casein kinase 2 (CK2) to treat patients with recurrent sonic hedgehog (SHH) driven Medulloblastoma.

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 US 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, Chief Executive Officer of Senhwa Biosciences.

Senhwa's clinical partner, the Pediatric Brain Tumor Consortium (PBTC,, is currently conducting a Phase I/II 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 US National Institute of Health - Cancer Therapy Evaluation Program (CTEP).

Medulloblastoma is the most common cancerous brain tumor in children, but no targeted therapy is currently available. On July 6, 2020, Silmitasertib was also granted Rare Pediatric Disease (RPD) Designation from the US FDA. If certain criteria are met with the RPD Designation, Senhwa is eligible for a transferrable Priority Review Voucher (PRV). The PRV allows its recipient an expedited review process of any one of its new drug products from a ten-month to a six-month timeframe.


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