CTI BioPharma (CTIC) to Submit a New Drug Application (NDA) for the Accelerated Approval of Pacritinib for the Treatment of Myelofibrosis Patients with Severe Thrombocytopenia.
The company has reached an agreement to submit an NDA for the potential accelerated approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet count less than 50 x 109/L).
The NDA will be based on the available data from the Company’s completed Phase 3 PERSIST-1 and PERSIST-2 trials and the Phase 2 PAC203 dose-ranging trial. The FDA has agreed to a rolling NDA submission which is expected to commence within a few weeks, with completion of the NDA submission anticipated in the first quarter of 2021. The ongoing Phase 3 PACIFICA trial is expected to be completed as a post-marketing commitment.
“Since the completion of the PAC203 Phase 2 dose-ranging trial, we have been working collaboratively with the FDA to identify an expeditious approval pathway for pacritinib in myelofibrosis patients with severe thrombocytopenia, a patient population with an important unmet medical need due to reduced survival and limited therapeutic options. During a recent Pre-NDA meeting, we identified a data package from the PERSIST-1, PERSIST-2 and PAC203 Phase 2 trials that will serve as the basis for an accelerated approval application. In particular, we discussed risk mitigation measures to address the FDA’s prior concerns regarding safety,” said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. “In myelofibrosis patients, severe thrombocytopenia occurs as a result of disease or drug-related toxicity from current therapies. There is no approved drug that specifically addresses the unmet need of the myelofibrosis patients who have severe thrombocytopenia. Pacritinib has demonstrated clinical benefit in treating these patients in multiple trials and now has the potential to become a new treatment option for treatment-naïve and second-line myelofibrosis patients in 2021.”
Analyst views on CTI BioPharma (CTIC)
JMP analyst Reni Benjamin and Needham analyst Chad Messer note that CTI Biopharma announced that the FDA agreed to an accelerated approval pathway for pacritinib in myelofibrosis patients with severe thrombocytopenia, and said it expects to complete a rolling NDA submission by Q1 2021.
With a rolling NDA for pacritinib in MF patients with severe thrombocytopenia expected to complete submission in Q1 2021; an ongoing study in hospitalized patients with COVID-19; an IST with results expected in Q4 for GvHD, and a cash position of $61M, Benjamin continues to recommend CTIC.
Is CTI BioPharma (CTIC) a good investment?
Shares of CTI BioPharma (CTIC) appear to be a very good investment option, the Money Midnight Indicator is expecting its price to increase considerably in the next several years. The majority of the metrics point to this investment being highly attractive.
