Sumitomo Pharma’s Ewing Sarcoma Candidate Gains Orphan Drug Status

Sumitomo Pharma Oncology has received FDA’s Orphan Drug designation for its TP-1287 candidate to treat Ewing sarcoma, a rare cancer that typically occurs in children or teenagers.

TP-1287 is an oral CDK9 protein inhibitor, which has been shown to inhibit tumor growth in preclinical models of blood cancers and several tumor types.

The drug candidate is being evaluated in a phase 1 study in patients with advanced metastatic or progressive solid tumors who are either resistant to or can’t tolerate the standard therapy.

TP-1287 has previously received the FDA’s Rare Pediatric Disease designation.

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