FDA grants orphan drug designation to silmitasertib for biliary tract cancer
The FDA granted orphan drug designation to silmitasertib for treatment of biliary tract cancer.
Silmitasertib (Senhwa Biosciences) is a highly selective inhibitor of casein kinase 2 (CK2).
“We are pleased to receive [orphan drug designation] for silmitasertib for the treatment of biliary tract cancer, a rare, malignant disease for which there are no effective therapies,” Mei-Hui Kuo, acting CEO of Senhwa Biosciences, said in a company-issued press release. “[Orphan drug designation] represents an important regulatory milestone that has the potential to expedite the clinical development of silmitasertib.”
Standard first-line treatment for biliary tract cancer consists of chemotherapy with gemcitabine with cisplatin. There are no standard regimens for patients with locally advanced or metastatic disease after first-line chemotherapy fails.
Preclinical studies showed CK2 inhibition with silmitasertib prevents DNA repair, induces apoptosis, and enhances the antitumor activity of gemcitabine and cisplatin, according to the release.