CTI heads to the FDA with its Baxalta-partnered cancer drug

CTI BioPharma ($CTIC) is planning an early FDA submission for its blood cancer treatment, plotting to hand in the results from a single Phase III trial in hopes of winning approval.

The drug, partnered with Baxalta ($BXLT), is a kinase inhibitor called pacritinib that is designed to treat the rare bone marrow malignancy myelofibrosis. In Phase III results disclosed earlier this year, pacritinib met its main goal by reducing spleen volume by 35% or more in myelofibrosis patients, reversing a deadly effect of the disease. The results stoked hopes the drug could eventually contend with Incyte's ($INCY) Jakafi, already approved to treat the disease.

Now CTI believes those data are enough to merit FDA approval in certain myelofibrosis patients, planning to submit the drug in the fourth quarter.

CTI is working through a second Phase III trial comparing pacritinib against JAK inhibitors like Jakafi, but waiting on results from that study, which is still enrolling, would delay a potential approval by about 14 months, the company said. Instead, the biotech is angling to first get pacritinib cleared for myelofibrosis sufferers who also have dangerously low platelet counts and later pitch a label expansion based on data from the other trial.

The news sent shares of CTI up about 9% on Monday. The Seattle-headquartered company, formerly called Cell Therapeutics, has endured a slew of regulatory setbacks over the past 5 years, repeatedly driving down its market cap as investors soured on management's approach to oncology R&D.

But Baxalta, then Baxter ($BAX), saw promise in pacritinib back in 2013, paying $60 million upfront for a share of the drug's revenue and promising CTI as much as $112 million more if the treatment meets its goals.

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