Gilead Sciences (GILD) said Tuesday that its antibody-drug conjugate Trodelvy was granted US Food and Drug Administration breakthrough therapy designation for the treatment of adults with extensive-stage small cell lung cancer whose disease has progressed on or following platinum-based chemotherapy.
The designation, which speeds up the FDA approval process, was based on results from a cohort of a phase 2 trial, which showed "encouraging" results for Trodelvy as a second-line treatment for extensive-stage small cell lung cancer, the company said.
Gilead said it plans to initiate a phase 3 clinical trial in extensive-stage small cell lung cancer patients.
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