The FDA’s Oncologic Drugs Advisory Committee (ODAC) recently recommended approval of one drug for sarcoma but rejected another. The panel voted 11 to 2 that clinical studies support a favorable benefit-risk assessment for use of pazopanib (Votrient) in treating patients with advanced soft-tissue sarcoma who have received prior chemotherapy. On the same day, ODAC voted 13 to 1 against the use of the investigational agent ridaforolimus (Taltorvic) as maintenance therapy for patients with metastatic soft-tissue sarcoma or bone sarcoma whose disease has not progressed after at least four cycles of chemotherapy.
The ODAC provides FDA with independent expert advice and recommendations. However, the final decision regarding approval is made by FDA.
Pazopanib is a kinase inhibitor that is already approved in the United States for the treatment of patients with advanced renal cell carcinoma. For the current indication being considered, ODAC reviewed findings from one phase III clinical study and one phase II study. The panel noted that patients with gastrointestinal stromal tumours (GIST) and adipocytic sarcomas were not included in the phase III trial of pazopanib.
“Treatment options for patients with advanced soft-tissue sarcoma are limited; we are therefore pleased that the committee took a favorable view of the clinical data for Votrient.” said Rafael Amado, MD, Senior Vice President, GlaxoSmithKline Oncology. “We look forward to continuing the regulatory process.”
Ridaforolimus is an investigational small-molecule inhibitor of mammalian target of rapamycin (mTOR), a protein that acts as a central regulator of protein synthesis, cell proliferation, cell cycle progression and cell survival, integrating signals from proteins, such as PI3K, AKT, and PTEN, known to be important to malignancy.
Merck and ARIAD Pharmaceuticals previously announced that the FDA has accepted for filing and review the New Drug Application (NDA) for ridaforolimus. As part of an exclusive license agreement with ARIAD, Merck is responsible for the development and worldwide commercialization of ridaforolimus in oncology. ARIAD intends to copromote ridaforolimus in the United States.
“Merck remains confident in the potential of the investigational agent ridaforolimus for an indication where patients have limited options,” said Eric Rubin, MD, Vice President, Clinical Research Oncology, Merck. “We remain committed to bringing forward this promising therapy for patients with metastatic sarcoma, and look forward to further discussions with the FDA regarding this application.” ■