Threshold glufosfamide enters Phase III
This article was originally published in Pharmaceutical Approvals Monthly
Threshold begins Phase III pancreatic cancer trial for glufosfamide following special protocol assessment agreement from FDA, the firm announces Sept. 13. The 306-patient study will randomize patients with metastatic pancreatic cancer refractory to first-line treatment to receive glufosfamide every three weeks on top of best supportive care or BSC alone. "As part of our registration and approval strategy, we are also planning to initiate, before the end of 2004, a Phase II clinical trial of glufosfamide in combination with Gemzar for the first-line treatment of inoperable locally advanced or metastatic pancreatic cancer," the firm says...
You may also be interested in...
A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.
Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals.
Unfounded expectation some firms have for FDA to protect their investments in preparing successful NDI notifications is part of industry’s overall interest in increased regulation of the market, says Steven Tave, Office of Dietary Supplement Programs director.