The Food and Drug Administration (FDA) has granted Orphan Drug designation to SY-5609 for the treatment of pancreatic cancer.

SY-5609 is a highly selective and potent oral inhibitor of the cyclin-dependent kinase 7 (CDK7). The safety and tolerability of SY-5609 is currently being evaluated in combination with chemotherapy (eg, gemcitabine, nab-paclitaxel) in patients with pancreatic cancer who have progressed following treatment with FOLFIRINOX in an ongoing phase 1 trial ( Identifier: NCT04247126).

“This Orphan Drug designation underscores the urgency of our efforts to develop SY-5609 for patients with pancreatic cancer, one of the most devastating and difficult to treat malignancies,” said David A. Roth, MD, Chief Medical Officer of Syros. “Based on the early data we reported last year, which demonstrated single-agent activity in heavily pretreated patients, as well as compelling preclinical data and a strong mechanistic rationale, we believe SY-5609 could deliver meaningful benefit to people with pancreatic cancer, whose tumors have otherwise eluded therapeutic intervention.”

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SY-5609 is also being evaluated in combination with atezolizumab in patients with BRAF-mutant colorectal cancer in the phase 1/1b INTRINSIC trial ( Identifier: NCT04929223).


Syros receives FDA Orphan Drug designation for SY-5609 for the treatment of pancreatic cancer. News release. Syros Pharmaceuticals, Inc. Accessed September 13, 2022.

This article originally appeared on MPR