FDA Grants Accelerated Approval to Carfilzomib for Multiple Myeloma

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Onyx Pharmaceuticals announced that the FDA has granted accelerated approval to carfilzomib (Kyprolis) for the treatment of patients with multiple myeloma who have received at least two prior therapies, including treatment with bortezomib (Velcade) and an immunomodulatory therapy, and have demonstrated disease progression on or within 60 days of completion of the last therapy.

The indication for carfilzomib is based on response rate; no data are available for carfilzomib that demonstrate an improvement in progression-free survival or overall survival.

“The approval of [carfilzomib] provides a treatment option to patients with multiple myeloma whose disease has progressed despite use of available therapies,” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “We are encouraged by the continued progress in the development of drugs for multiple myeloma over the past decade, offering improved treatment of this disease.”

Study Design

The safety and effectiveness of carfilzomib, which is administered intravenously, was evaluated in a study of 266 patients with relapsed multiple myeloma who had received at least two prior therapies, including bortezomib and thalidomide (Thalomid).

The study was designed to measure the percentage of patients who experienced complete or partial disappearance of tumor after treatment (overall response rate). The overall response rate was 23%. The median duration of response was 7.8 months.

The most common side effects observed in more than 30% of the study participants were fatigue, low blood cell count and blood platelet levels, shortness of breath, diarrhea, and fever. Serious side effects seen with carfilzomib included heart failure and shortness of breath. Patients should be monitored closely and treatment withheld if these serious side effects occur. ■




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