Merck & Co.’s Keytruda Gets Fighting Chance In TNBC
Successful KEYNOTE-522 Results May Sway FDA
The company previously was unsuccessful securing accelerated approval based on complete response data, but event-free survival results may be more persuasive.
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The data illustrate the growing importance of adjuvant settings of solid tumors for PD-1/PD-L1 inhibitors, which could make up more than one-quarter of their sales in 2025.
An executive told Scrip the company hopes to target all-comers as well as PD-L1-positive patients.
While much earlier in its development, the drug may be able to rival Gilead’s Trodelvy, which also targets TROP2 and showed similar response rates.