Onyx Pharmaceuticals, Inc announced that the company reached agreement with the US Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the phase-3 international randomized trial. This pivotal trial, which is expected to begin in the first half of 2010, will enrol patients with relapsed multiple myeloma following treatment with one to three prior regimens. It is designed to evaluate the efficacy of carfilzomib in combination with lenalidomide and low dose dexamethasone, versus lenalidomide and low dose dexamethasone alone.
"The SPA enables us to initiate this carfilzomib phase-3 combination trial in the first half of this year with increased clarity on the full approval pathway," said Michael Kauffman, chief medical officer at Onyx. "In the phase-1b data (from the "006" trial) reported at the American Society of Hematology meeting last December, carfilzomib showed promising response rates and good tolerability with this three-drug combination in patients with relapsed or refractory myeloma."
Dr Kauffman continued, "This planned phase-3 study complements and builds upon the encouraging single-agent carfilzomib data reported earlier in heavily pretreated patients with relapsed and refractory multiple myeloma. Despite the established use of existing therapies, over time virtually all multiple myeloma patients relapse and succumb to their disease, meaning new innovative agents are needed. As a medical community, we have made important strides in extending the life of myeloma patients and need to continue to identify new ways we can benefit those who have this disease."
Based on carfilzomib's efficacy and tolerability profile demonstrated to-date, Onyx is pursuing a broad approach to advancing this therapy for multiple myeloma patients.
A Special Protocol Assessment is a written agreement with the FDA on the design and planned analysis for a clinical trial.
Carfilzomib is a selective, next-generation proteasome inhibitor that has shown encouraging results in a broad clinical trial programme in multiple myeloma.
Onyx Pharmaceuticals is a biopharmaceutical company committed to improving the lives of people with cancer.