The FDA ( Food and Drug Administration ) has approved Kyprolis ( Carfilzomib ) to treat patients with multiple myeloma who have received at least two prior therapies, including treatment with Velcade ( Bortezomib ) and an immunomodulatory therapy.
According to the American Cancer Society, in 2012, an estimated 21,700 people will be diagnosed with multiple myeloma and 10,710 will die from the disease.
The safety and effectiveness of Kyprolis, 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 Velcade and Thalomid ( Thalidomide ).
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 Kyprolis included heart failure and shortness of breath. Patients should be monitored closely and treatment withheld if these serious side effects occur.
The drug was approved under the FDA’s accelerated approval program, which allows the Agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.
The program is designed to provide patients with earlier access to promising new drugs.
The company is required to submit additional clinical information after approval to confirm the drug’s clinical benefit. ( Xagena )
Source: FDA, 2012