US FDA delays decision on SpringWorks Therapeutics' tumor treatment (updated)

SpringWorks Therapeutics

05/06/2023 12:02

(Adds background on treatment in paragraph 4)
       June 5 (Reuters) - The U.S. Food and Drug Administration
(FDA) has extended its decision for SpringWorks Therapeutics
Inc's  SWTX.O  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)
 ((Sriparna.Roy@thomsonreuters.com))