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An investigational new prostate cancer drug developed by Merck has been backed for clinical trials in the US.
The FDA’s scientific advisory committee voted unanimously to give the drug Merck’s cancer pill ertugliflozin conditional approval in 2018 for treating cancer.
It is the first treatment approved for the condition in five years.
Last year it was also given conditional approval in Europe for the treatment of heart failure.
The US National Cancer Institute has estimated that in the UK there are more than 40,000 men diagnosed with prostate cancer each year. The disease is the most common cancer among men in the UK, accounting for about 11% of all male cancer cases.
Overall, prostate cancer is the most common type of cancer among men, accounting for about 11% of all male cancer cases.
Side effects
The panel will make its recommendation to the FDA to recommend approval and the FDA will make its final decision.
The German company’s stock was 3% lower on Friday after the committee announced it had voted 10-0 to recommend the drug be approved, but the problems raised by panel members could mean it is not approved.
They called the benefit of the drug “precisely” lacking.
In terms of its side effects, the biggest concern is potential risk of low blood sugar levels, which were identified when the drug was tested in older patients.
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BBC health reporter Rowena Caldwell
The FDA is not the only body reviewing the new drug. It is also being assessed by the European Medicines Agency.
The FDA’s advisory committee reviewed the drug last month, with Merck responding to its questions by Thursday.
And on Thursday evening it was decided that it will not be approved for men who are overweight and have diabetes – a problem identified by advisory committee members.
Around 3,000 men with diabetes will die from prostate cancer every year, according to the National Cancer Institute.