Medarex

Medarex gets U.S. FDA SPA to initiate registration trial of ipilimumab in melanoma patients

Published in Law and Health Weekly, July 22nd, 2006

Medarex, Inc. (MEDX) announced it received a Special Protocol Assessment (SPA) letter from the U.S. Food and Drug Administration (FDA) to initiate a registrational clinical trial of ipilimumab (MDX-010) used in combination with chemotherapy in previously untreated (first-line) metastatic melanoma patients.

The SPA agreement with the FDA concerns the suitability of the trial design to support regulatory approval.

The randomized, double-blind, two-arm registrational clinical trial is expected to commence shortly. The trial is expected to enroll approximately 500 patients with previously untreated stage III or stage IV metastatic melanoma. Patients will...

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Source: Law and Health Weekly (2006-07-22)

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