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FDA Says it Needs More Clinical Evidence for Approving Sunesis Pharmaceutical Cancer Medicine

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Published on : Jul 24, 2015

Sunesis Pharmaceuticals Inc has stated that the Food and Drug Administration of the U.S. has called for more clinical evidence that can confirm the benefits of the cancer drug manufactured by the company before it can be approved. The news has not been taken by investors it seems; shares of Sunesis Pharmaceuticals Inc went down 60 per cent in after market trade.

Sunesis Pharmaceuticals Inc.’s highly anticipated cancer medicine vosaroxin had failed in a late stage trial held in October. The results of the trail did not show satisfactory results in the overall survival of the subjects of the drug as compared to a placebo.

The FDA needed further evidence before the company filed its application for marketing of the drug, Sunesis Pharmaceuticals Inc. said in an official statement on Thursday.

However, the medicine had gained approval from the European Medicines Agency (EMA) for submitting a marketing application, added Sunesis.

Analysts say that the U.S. Food and Drug Administration has a history of sticking to statistics while the EMA takes the whole picture into consideration. Analysts expect the decision on the European approval to come by the year 2016.

However, the approval from the United States can be delayed by a few years as Sunesis will be required to rerun the trials or undertake additional trials. It is being said that Sunesis is well funded till the mid of the year 2016 and that undertaking further trials will be not an issue. 

The drug is being tested for patients with the cancer named acute myeloid leukemia, which is a fast growing cancer and affects the blood and bone marrow. This cancer is most usually seen in senior patients.

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