Blood Cancer Drug Pacritinib Withdrawn by FDA
The US Food and Drug Administration (FDA) have put a hold on CIT BioPharma Corp's blood cancer drug Pacritinib.
Reuters reports that CTI has announced its withdrawal for the drug's application as the FDA has put a full clinical hold on it. Pacritinib is designed for patients with myelofibrosis (MF).
Myelofibrosis is a chronic blood cancer where the bone marrow's ability to produce normal blood cells are impaired by the growth of too much scar tissues. According to Mayo Clinic, MF is an uncommon type of chronic leukemia and it can get worse with time. Symptoms include bone pain, fever, easy bruising and bleeding and weakness or tiredness because of anemia.
Last week, the company received a notice from the FDA for a partial clinical hold on the clinical studies because of excess mortality and various adverse reactions among patients. According to Street Insider, the partial clinical hold may still enlist new patients or start taking the drug Pacritinib as initial or crossover treatment. Patients who have not seen significant positive changes from the drug after 30 weeks are advised to stop using it. CTI has also been recommended to modify protocols in randomized trials to not allow crossover medications, provide notifications and edit statements regarding the investigation.
The numerous deaths were observed during the non-randomized crossover period of the trials after the first 24 weeks of randomized treatment. During this period, patients had the freedom to take the Pacritinib treatment.
However, with the full clinical hold from the FDA the patients are advised to stop taking Pacritinib. No patient will also be enrolled or have it as an initial or crossover treatment.
Various adverse reactions to the drug include cardiac arrest, brain hemorrhage, and heart failure.
"The deaths in PERSIST-2 in Pacritinib-treated patients include intracranial hemorrhage, cardiac failure, and cardiac arrest," CTI said in a statement, as reported by Fierce Biotech. "The FDA made recommendations that supersede the recommendations made by the FDA in connection with the partial clinical hold imposed by the FDA on Feb. 4.
"The current recommendations include conducting dose exploration studies for Pacritinib in patients with myelofibrosis, submitting final study reports and datasets for PERSIST-1 and PERSIST-2, providing certain notifications, revising relevant statements in the related Investigator's Brochure and informed consent documents and making certain modifications to protocols. In addition, the FDA recommended that the company request a meeting prior to submitting a response to full clinical hold."