CHMP recommends Gilead's Trodelvy plus Keytruda for first-line TNBC
The positive opinion based on Phase 3 ASCENT-04 study showed 35% reduced risk of progression or death in PD-L1 positive patients.
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Biopharmaceutical company focused on virology, oncology and inflammation
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In short: Gilead expanded its oncology and HIV portfolios with key FDA approvals, strategic acquisitions, and positive clinical trial results.
The positive opinion based on Phase 3 ASCENT-04 study showed 35% reduced risk of progression or death in PD-L1 positive patients.
The ISL/LEN regimen maintained virological suppression and was noninferior to daily therapy at Week 48.
The approval is for first-line metastatic triple-negative breast cancer, with coverage on patient impact.
Approval based on ASCENT-03 and ASCENT-04 trials showing significant progression-free survival benefit.
Trials show lenacapavir can all but eliminate the risk of HIV infection. Yet in the countries where it was tested, most people can't afford it.
Gilead (GILD) doesn't possess the right combination of the two key ingredients for a likely earnings...
ViiV says two-drug Dovato matches Gilead’s Biktarvy in HIV suppression in a phase 3b study. Read mor...
In today's Pharmaceutical Executive Daily, the FDA approves Gilead's Trodelvy for the first-line tre...
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