A pivotal Phase III trial of GALE-401 in patients with essential thrombocythemia
Phase of Trial: Phase III
Latest Information Update: 15 Mar 2017
At a glance
- Drugs Anagrelide (Primary)
- Indications Essential thrombocythaemia
- Focus Therapeutic Use
- Sponsors Galena Biopharma
- 15 Mar 2017 According to a Galena Biopharma media release, after the meeting US FDA confirmed that the GALE-401 development program is appropriate for a NDA filing using the 505(b)(2) regulatory pathway in patients with essential thrombocythemia who are intolerant or resistant to hydroxyurea.
- 09 Nov 2016 According to a Galena Biopharma media release, company expects to initiate this trial in the second quarter of 2017.
- 30 Aug 2016 New trial record