After the success of a single arm trial being conducted by Onyx Pharmaceuticals for its multiple myeloma drug Kyprolis, the FDA has given the green signal to it. The FDA has kept one condition that the drug should only be provided at the time when two other drugs have failed to work on patients.
The FDA said if patients have received bortezomib and an immunomodulatory agent, and then also they are not able to get relief then they are allowed to have Kyprolis. The clinical trial, on the basis of which, the company got approval, had 266 patients suffering from multiple myeloma.
An Independent Review Committee was formed to analyze the efficacy of the trial. They used the International Myeloma Working Group criteria to reach at the conclusion.
"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, who is heading the Hematology and Oncology departments in the FDA.
Experts said that Kyprolis will work to fulfill the unmet need of patients, who have been down with severe multiple myeloma, and have tried other drug, but have not received comfort. The drug is lighter and has better solubility than other drugs.
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