(Reuters) – The U.S. Food and Drug Administration (FDA) has extended its decision for SpringWorks Therapeutics Inc’s tumor treatment by three months as the health regulator needs more time to review additional data, the company said on Monday.
No additional data or studies have been requested by the FDA at this time, according to SpringWorks.
The company said the FDA notified on Friday that it required more time to review additional analyses of previously submitted data that had been provided by SpringWorks in response to the health regulator’s information requests.
SpringWorks’ therapy Nirogacestat is in a late-stage trial for treating desmoid tumors, which are noncancerous growths that occur in connective tissues.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shounak Dasgupta)
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