CTI BioPharma Receives Accelerated FDA Approval

Mar 1, 2022 By MarketDepth

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FDA Approval

CTI BioPharma Corp. (Nasdaq: CTIC) announced that the U.S. Food and Drug Administration has approved VONJO (pacritinib) for the treatment of adults with myelofibrosis and thrombocytopenia after the market closed on Monday, February 28th.

Up Almost 50%

Shares of CTI BioPharma Corp. (Nasdaq: CTIC) gained over 48% during the premarket hours.

VONJO becomes the first approved therapy that specifically addresses the needs of patients with cytopenic myelofibrosis.

“Today’s approval of VONJO establishes a new standard of care for myelofibrosis patients suffering from cytopenic myelofibrosis.”

John Mascarenhas, M.D., Associate Professor, Medicine, Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York

The accelerated approval is based on efficacy results from the pivotal Phase 3 PERSIST-2 study of VONJO and as part of the approval, the company is now required to describe a clinical benefit in a confirmatory trial. To fulfill this post-approval requirement, CTI plans to complete the PACIFICA trial, with expected results in mid-2025.

“We are fully funded for commercial launch, following our debt and royalty transactions with DRI, and we look forward to providing VONJO, the potential best-in-class therapy for cytopenic myelofibrosis patients, to patients within 10 days.”

Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma