Onyx Pharmaceuticals Inc (ONXX)

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8:04AM Onyx Pharma announces agreement with the FDA on a special protocol assessment for planned phase 3 carfilzomib combination trial in relapsed multiple myeloma (ONXX) 28.62 : Co announces it reached an agreement with the FDA on a Special Protocol Assessment for the Phase 3 international randomized trial. This pivotal trial, which is expected to begin in the first half of 2010, will enroll 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, in the Phase 2b data 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."