PACRITINIB TAKEN OFF FDA CLINICAL HOLD
CTI BioPharma will start a new trial, PAC203 for MyelofibrosisBig news today on MPN drug development, as CTI BioPharma announces that the FDA has removed the full clinical hold they had placed on Pacritinib, a drug aimed at Myelofibrosis, in 2016. After the FDA placed Pacritinib on hold due to toxicity concerns, many MPN patients and even some clinicians and researchers contacted the FDA about the need for additional therapies. The company will start a new trial in the second quarter of 2017: “The new trial, PAC203 plans to enroll up to approximately 105 patients with primary myelofibrosis who have failed prior ruxolitinib therapy to evaluate the safety and the dose response relationship for efficacy (spleen volume reduction at 24 weeks) of three dose regimens: 100 mg once-daily, 100 mg twice-daily (BID) and 200 mg BID. The 200 mg BID dose regimen was used in PERSIST-2.” Click here to read the full press release from CTI. As always, we don’t take a position on this or any drug, but are heartened to see the possibility of more options for people with MPN. Links to previous news updates about Pacritinib:
- Update: Pacritinib Now on Full Clinical Hold : Did you know that Phase 3 trials for myelofibrosis drug, Pacritinib is currently on full clinical hold? Get the information you need from MPNRF here.
- Pacritinib remains on full clinical hold but FDA OKs individual INDs : FDA OK’s Pacritinib for some patients; Full clinical hold remains
- Posters related to Pacritinib from ASCO 2016 : Pacritinib posters from ASCO on survival and comparison to best available therapy.