On August 1, 2024 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to soquelitinib for the treatment of adult patients with relapsed or refractory peripheral T cell lymphoma (PTCL) after at least two lines of systemic therapy (Press release, Corvus Pharmaceuticals, AUG 1, 2024, View Source [SID1234645257]).
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"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."
The Fast Track program is designed to facilitate the development and expedite the review of new drugs or biologics that are intended to: 1) treat serious or life-threatening conditions and 2) demonstrate the potential to address unmet medical needs. Fast Track designation can accelerate development and review of new drug and biological products by increasing the level of communication between FDA and drug developers and by enabling the FDA to review portions of a drug application on a rolling basis. In addition to Fast Track Designation, soquelitinib has also been granted FDA Orphan Drug Designation for the treatment of T cell lymphoma, which provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.