FDA announces hold on Phase II trial of PEGPH 20 for Pancreatic Cancer - Halozyme
The FDA has announced that a clinical hold has been placed on patient enrollment and dosing of PEGPH 20 (PEGylated rHuPH20), from Halozyme Therapeutics, in an ongoing Phase II trial (Study 202) evaluating PEGPH 20 in patients with Pancreatic Cancer. According to the FDA, this action was being taken in view of the company's recent decision to temporarily halt enrollment and dosing of PEGPH20 in the Phase II trial.
The company is assessing the possible difference in the thromboembolic event rate between the patients treated with PEGPH 20 versus the patients treated without PEGPH 20 in the trial and will be providing this information to the Data Monitoring Committee and the FDA.
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