FDA Fast Track Designation Granted to Soquelitinib for Treatment of Patients with R/R PTCL

“The granting of Fast Track Designation by the FDA highlights the significant unmet need for patients with relapsed or refractory PTCL,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “The current treatment options for these patients provide limited efficacy and are associated with significant toxicity, and there are no FDA fully approved agents. There continues to be strong interest in soquelitinib from investigators at sites with deep experience treating T cell lymphomas and we are on track to initiate patient enrollment in our registrational Phase 3 trial in PTCL in the third quarter 2024.”

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