CTI/Baxalta Withdraw Pacritinib NDA Following More Deaths
This article was originally published in Scrip
Things have gone from bad to worse for CTI BioPharma Corp. this week. Shares lost 60% of their value to close at $0.44 on Feb. 8 following news the US FDA had placed a partial clinical hold on myelofibrosis treatment candidate pacritinib. And now, the company has received further communication from the FDA that the IND for pacritinib has been placed on full clinical hold.
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With the commercial opportunity in the myelofibrosis market expected to double to over $1bn in the next five years, competition to Incyte/Novartis's Jakafi seems further away than ever as CTI BioPharma pulls the European regulatory filing for pacritinib.
The US company is encouraged by top-line efficacy Phase III results showing pacritinib was effective in high-risk myelofibrosis patients with low platelet counts, and has said it is working with the FDA to lift the clinical hold imposed earlier this year because of side-effect concerns.