FDA Grants Breakthrough Therapy Designation to Incyte's INCA033989 for CALR-Mutant Essential Thrombocythemia
The FDA has granted Breakthrough Therapy designation to Incyte's INCA033989 for treating essential thrombocythemia with a Type 1 CALR mutation. Incyte plans to develop the drug further for both Type 1 and non-Type 1 CALR mutations, with a registrational program set to begin next year. This designation highlights a significant advancement for Incyte in addressing treatment-resistant or intolerant patients.
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Incyte Corporation’s INCA033989 for the treatment of patients with essential thrombocythemia (ET) harboring a Type 1 CALR mutation who are resistant or intolerant to at least one cytoreductive therapy. Incyte plans to further develop INCA033989 for patients with both Type 1 and non-Type 1 CALR mutations and is preparing to initiate a registrational program for these patients in the first half of next year. No grant or regulatory approval was noted for organizations other than Incyte Corporation. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Incyte Corporation published the original content used to generate this news brief on December 08, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT) Original Document: here
