Oncologic Drugs Advisory Committee Meeting

Oncologic Drugs Advisory Committee Meeting
[Committee Meeting on March 20, 2012 from 8:00 a.m. to 5:00 p.m. (Day 1 of 2)]

During the morning session, the committee will discuss supplemental New Drug Application (sNDA) 022465/S-010, with the trade name Votrient (pazopanib hydrochloride) tablets, application submitted by Glaxo Wellcome Manufacturing Pte Ltd doing business as GlaxoSmithKline. The proposed indication (use) for this product is for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The phase 3 STS trial population excluded patients with adipocytic STS or gastrointestinal stromal tumors (GIST).

During the afternoon session, the committee will discuss New Drug Application (NDA) 022576, with the proposed trade name Taltorvic (ridaforolimus) tablets, application submitted by Merck Sharp & Dohme Corp. The proposed indication (use) for this product is for the treatment of adult and pediatric patients (aged 13 through 17 years with weight over 100 lb or 45.4 kg) with metastatic soft tissue sarcoma or bone sarcoma as a maintenance therapy for patients who have completed at least 4 cycles of chemotherapy without evidence of disease progression.