Kyprolis (carfilzomib) was recently approved by the FDA to treat patients with multiple myeloma who have received at least 2 prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy.
“The approval of Kyprolis 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.”
The safety and effectiveness of the intravenous drug carfilzomib was evaluated in a study of 266 patients with relapsed multiple myeloma. Patients had received at least 2 prior therapies, including Velcade and Thalomid (thalidomide). The percentage of patients who experienced complete or partial disappearance of tumor after treatment 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 diarrhea, fatigue, fever, low blood cell count, low blood platelet levels, and shortness of breath. Heart failure and shortness of breath were serious side effects seen with carfilzomib. Patients should be monitored closely and treatment withheld if these serious side effects occur.
The drug is being approved under the FDA’s accelerated approval program.
Source: FDA.