- The FDA approved CTI BioPharma Corp's (NASDAQ:CTIC) Vonjo (pacritinib) for treating adult patients with myelofibrosis, a type of bone marrow cancer with low blood platelets count.
- Pacritinib is a JAK inhibitor and will compete with Incyte Corporation's (NASDAQ:INCY) Jakafi and Bristol Myers Squibb's Co (NYSE:BMY) Inrebic, which were approved in 2011 and 2019, respectively for myelofibrosis.
- CTI BioPharma Chief Executive Officer Adam R. Craig said, "We are fully funded for commercial launch, following our debt and royalty transactions with DRI, and we look forward to providing VONJO to patients within 10 days."
- The Company said the drug was approved under priority, and the nod triggered a $60 million payment from DRI Healthcare Trust.
- The accelerated approval is based on efficacy results from the pivotal Phase 3 PERSIST-2 study.
- Pacritinib 200 mg twice daily showed 29% of patients had a reduction in spleen volume of at least 35% compared to 3% of patients receiving the best available therapy, including Jakafi (ruxolitinib).
- As part of the accelerated approval, CTI must describe a clinical benefit in a confirmatory trial. CTI plans to complete the PACIFICA trial to fulfill this post-approval requirement, with expected results in mid-2025.
- In November, the agency had delayed its decision for the drug by three months to review additional data previously submitted by the Company.
- Price Action: CTIC shares closed 10.5% higher at $2.10 during after-hours trading on Monday.
