US FDA grants RPD designation to Senhwa Biosciences' Silmitasertib for pediatric neuroblastoma
- Senhwa Biosciences' Silmitasertib (CX-4945) received rare pediatric disease designation (RPDD) from the US FDA for neuroblastoma.
- Silmitasertib is a first-in-class CK2 inhibitor that showed antitumor activity in pre-clinical studies.
- The RPD designation qualifies the drug for the priority review voucher (PRV) program, encouraging the development of novel therapies for rare pediatric diseases.
- Neuroblastoma is the third most common pediatric cancer, with an estimated 700 to 800 new cases annually in the US.
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