FDA Extends Review Period For CTI BioPharma's Bone Marrow Cancer Candidate

The FDA has extended the review period for CTI BioPharma Corp's CTIC pacritinib marketing application for myelofibrosis.
The application for pacritinib covers adult patients with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a baseline platelet count of over 50 × 109/L.
See here Benzinga's Full FDA Calendar.
The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to February 28, 2022.
In Q2 of 2021, the FDA granted priority review for CTI's application for patients with myelofibrosis with a PDUFA date of November 30.
In the course of product labeling discussions, the FDA requested additional clinical data, which was submitted to the agency on November 24.
The FDA informed the Company that it considers the data submission to constitute a "major amendment" to the application, thus extending the PDUFA date to provide additional time for a full submission review.
Also See: CTI BioPharma's COVID-19 Candidate Misses Primary Endpoint Mark In Phase 2 Trial.
Price Action: CTIC shares are down 17.8% at $1.85 during the premarket session on the last check Wednesday.