FDA Approves New Combination Therapy for Treatment of Multiple Myeloma

The FDA approved Kyprolis (carfilzomib) for injection in combination with other therapies for the treatment of patients with relapsed or refractory multiple myeloma who have received 1 to 3 lines of therapy.

The drug was also approved as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received 1 or more lines of therapy.

Approval was based on a Phase III head-to-head ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) study with the primary endpoint being progression-free survival. Patients with relapsed multiple myeloma who were treated with carfilzomib in combination with dexamethasone achieved 50% greater progression-free survival of 18.7 months compared to 9.4 months in those receiving Velcade (bortezomib) and dexamethasone (HR=0.53; 95% CI: 044, 0.65 P<0.0001). Patients were treated until disease progression.

The most common adverse reactions were anemia, diarrhea, dyspnea, fatigue, insomnia, pyrexia, and thrombocytopenia.

This is the second indication for carfilzomib in 6 months. It was previously approved another in combination with lenalidomide and dexamethasone (KRd) for the treatment of patients with multiple myeloma who have received 1 to 3 prior lines of therapy.