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Details:
In the first part, pexidartinib 800 mg/day (400 mg twice a day on an empty stomach) will be administered to evaluate the tolerability and pharmacokinetics of pexidartinib to determine the initiation of the second part of the study.
Lead Product(s): Pexidartinib
Therapeutic Area: Oncology Product Name: PLX3397
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 09, 2021
Details:
CHMP of the European Medicines Agency has adopted a negative opinion on the Marketing Authorization Application For pexidartinib for the treatment of a subset of adult patients with severe tenosynovial giant cell tumor (TGCT).
Lead Product(s): Pexidartinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 26, 2020
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