Emerging Medication for mCRPC Gets FDA Fast Track Designation for Adjunctive Use with Radiation Therapy
Currently in a phase I trial for solid prostate cancer tumors, the deoxycytidine kinase inhibitor TRE-515 garnered the fast track designation for possible combination use with Pluvicto in treating mCRPC.
The Food and Drug Administration (FDA) has issued a fast track designation for adjunctive use of TRE-515, an oral deoxycytidine kinase inhibitor, with lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) in the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
Trethera, the developer of TRE-515, said the medication is currently being evaluated as an oral monotherapy in a phase I study for the treatment of advanced prostate cancer (PCa) tumors.
TRE-515, an emerging oral deoxycytidine kinase inhibitor, has been granted a FDA fast track designation for adjunctive use in combination with lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) for the treatment of metastatic castration-resistant prostate cancer (mCRPC). (Image courtesy of Adobe Stock.)
Preliminary findings from the multicenter dose-escalation study suggest that TRE-515 may offer anti-tumor activity and researchers have also noted an 18-fold escalation of dosing with the agent without any limiting toxicity, according to Trethera.
“I believe that TRE-515 has the potential to make a meaningful difference in the lives of prostate cancer patients and I am pleased that Trethera has received this Fast Track designation to expedite development,” said Michael Jung, Ph.D., a distinguished UCLA professor of chemistry and biochemistry, and inventor of TRE-515. “The chemical structure of TRE-515 was designed for a specific, on-target, binding to create an optimal drug profile.”
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