Cti Biopharm Corp. (NASDAQ: CTIC) stock gains by 6.69% in the current market trading session. CTIC is a biopharmaceutical business focusing on the acquisition, development, and commercialization of innovative targeted medicines for blood-related malignancies that provide patients and healthcare providers with a distinct advantage. CTIC focus its efforts on medicines for malignancies of the blood, where there is an unmet clinical need.
CTI BioPharma Corp. announced today that it has received approval from the U.S. Food and Drug Administration. The Food and Drug Administration (FDA) has granted Priority Review to pacritinib’s New Drug Application (NDA) as a therapy for myelofibrosis patients with chronic thrombocytopenia (platelet counts fewer than 50 x 109/L). The anticipated action date for the Prescription Drug User Fee Act (PDUFA) is November 30, 2021. The FDA does not intend to schedule a meeting of the advisory committee to consider the NDA at this time.
The NDA was approved based on results from the PERSIST-2 and PERSIST-1 Phase 3 clinical trials, as well as the Phase 2 PAC203 clinical trial, with an emphasis on severely thrombocytopenic (platelet counts less than 50 x 109/L) patients enrolled in these research who obtained pacritinib 200 mg twice a day, including both frontline treatment-naive patients and patients who had previously been treated with JAK2 inhibitors.
In the PERSIST-2 study, 29 percent of patients with chronic thrombocytopenia who were handled with pacritinib 200 mg twice a day had a decrease in spleen volume of at least 35 percent, compared to 3 percent of patients receiving the best available therapy, which included ruxolitinib.; 23% of patients had a reduction in total symptom scores of at least 50 percent compared to 3 percent of patients obtaining the best possible therapy, which included ruxolitinib Adverse effects were mainly low-grade, controllable with supportive care, and seldom resulted in discontinuation in the same group of patients treated with pacritinib. The platelet count and hemoglobin levels were also brought back to normal.
Adam R. Craig, President, and CEO of CTI BioPharma stated:
CTIC is thrilled that the FDA has approved their NDA, bringing them one step closer to their aim of delivering a new therapy option for myelofibrosis patients with chronic thrombocytopenia. They anticipate that, with commercial preparations beginning, they will be well-positioned for a possible launch in the United States later this year. CTIC is excited to collaborate with the FDA while it reviews their application.