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Sept 25 — Merck and Daiichi Sankyo have voluntarily withdrawn their US application seeking accelerated approval for their experimental lung cancer therapy, the companies said on Friday.
The decision followed discussions with the US Food and Drug Administration, which determined that the data from a mid-stage clinical study did not satisfy requirements needed to support an early green light.
The therapy, called ifinatamab deruxtecan, was under review to treat adults with an aggressive condition known as extensive-stage small cell lung cancer whose disease had worsened after standard chemotherapy.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Maju Samuel and Shilpi Majumdar)
