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- The FDA gave its full approval to Merck & Co Inc's (NYSE:MRK) Keytruda as a treatment for first-line advanced urothelial carcinoma (bladder cancer) patients who are not eligible for platinum-based chemo.
- Keytruda earned an accelerated nod in first-line locally advanced or metastatic urothelial cancer (UC) patients who were not eligible for chemo back in May 2017.
- But the confirmatory KEYNOTE-361 study, which aimed to expand Keytruda into patients who had been previously treated with platinum-based chemo, failed both of its key primary endpoints, effectively shutting down Keytruda's broader use.
- Earlier this year, Keytruda's first-line approval in bladder cancer was one of the indications considered by an FDA adcomm for continued support.
- The adcomm voted 5-3 to maintain the accelerated approval.
- Related Content: Oncologic Drugs Adcomm Backs Merck's Keytruda, Roche's Tecentriq Accelerated Approvals In Bladder Cancer.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: MRK shares are up 0.73% at $76.85 during the premarket session on the last check Wednesday.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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