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Roche’s giredestrant secures FDA priority review for breast cancer

The US FDA has accepted priority review of the NDA for Roche’s investigational oral SERD, giredestrant, for breast cancer.

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pharmaceutical-technology.comStai leggendo2 mesi fa

Roche’s giredestrant secures FDA priority review for breast cancer

The US FDA has accepted priority review of the NDA for Roche’s investigational oral SERD, giredestrant, for breast cancer.

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morningstar.com2 mesi fa

FDA Accepts New Drug Application for Genentech’s Giredestrant in ER-Positive Early-Stage Breast Cancer, the…

Genentech's giredestrant, an oral SERD, cuts recurrence/death risk 30% in early-stage ER+ breast cancer—first adjuvant advance in 20 years. Potential new standard-of-care for 90% of early cases; FDA decision November 2026, addressing unmet need in high-relapse patient population.

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Timeline cronologica

martedì 2 giugno 2026·morningstar.com
FDA Accepts New Drug Application for Genentech’s Giredestrant in ER-Positive Early-Stage Breast Cancer, the First and Only Oral SERD With…
FDA Accepts New Drug Application for Genentech’s Giredestrant in ER-Positive Early-Stage Breast Cancer, the First and Only Oral SERD With Positive Phase III Results in the…
martedì 2 giugno 2026·fiercebiotech.com
ASCO: Roche, head held high, details oral SERD's first-line flop in breast cancer

To Roche, a phase 3 flop in first-line breast cancer does not erase the megablockbuster potential of its oral SERD drug giredestrant even as competition mounts. | To Roche, a…

Roche’s giredestrant secures FDA priority review for breast cancer

FDA Accepts New Drug Application for Genentech’s Giredestrant in ER-Positive Early-Stage Breast Cancer, the…

Timeline cronologica

FDA Accepts New Drug Application for Genentech’s Giredestrant in ER-Positive Early-Stage Breast Cancer, the First and Only Oral SERD With…

ASCO: Roche, head held high, details oral SERD's first-line flop in breast cancer

ASCO: Roche, head held high, details oral SERD's first-line flop in breast cancer

Roche’s giredestrant secures FDA priority review for breast cancer