RE:RE:Timeline to Accelerated ApprovalNow this one is interesting to me....incredible what is being approved these days, Am I reading this one right that CTI got AA approval despite the many adverse reactions listed in their NR? Unbelievable in comparison to what TLT offers. The FDA bar appears to be very low these days, at least for some things......go TLT!
The accelerated approval is based on efficacy results from the pivotal Phase 3 PERSIST-2 study of VONJO in patients with myelofibrosis (platelet counts less than or equal to 100 × 109/L). Patients were randomized 1:1:1 to receive VONJO 200 mg twice daily (BID), VONJO 400 mg once daily (QD) or best available therapy (BAT). Prior JAK2 inhibitor therapy was permitted. In this study, in the cohort of patients with baseline platelet counts below 50 × 109/L who were treated with pacritinib 200 mg BD, 29% of patients had a reduction in spleen volume of at least 35% compared to 3% of patients receiving best available therapy, which included ruxolitinib. As part of the accelerated approval, CTI is required to describe a clinical benefit in a confirmatory trial. To fulfil this post-approval requirement, CTI plans to complete the PACIFICA trial, with expected results in mid-2025.
The most common adverse reactions (≥20%) following VONJO 200 mg twice daily were diarrhea, thrombocytopenia, nausea, anemia and peripheral edema. The most frequent serious adverse reactions (≥3%) following VONJO 200 mg twice daily were anemia, thrombocytopenia, pneumonia, cardiac failure, disease progression, pyrexia and squamous cell carcinoma of skin
Pandora wrote:
CTI Biopharma (CTIC), the leader in this months Pinnacle Digest stock picking contest, got "Accelerated Approval" for their drug at the end of February and their share price has gone from $1.90 to $5.23