Priority Review

RegulatoryJune 16, 2026

FDA Accepts NDA for Roche's Giredestrant in Early-Stage ER-Positive Breast Cancer

The FDA has accepted Roche's NDA for giredestrant, an oral SERD, under priority review based on phase III data showing a 30% reduction in invasive disease recurrence or death compared to standard therapy.

Recent events(10)

FDA Grants Priority Review for Pfizer's Marstacimab (HYMPAVZI) Supplement

FDA Grants Priority Review for TZIELD (Teplizumab) Supplement

FDA Grants Priority Review for Welireg Supplement from Merck

Historical activity(1)

Roche — Tecentriq

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Ifinatamab Deruxtecan Receives Priority Review for ES-SCLC in the U.S.

FDA Grants Priority Review for KEYTRUDA and KEYTRUDA QLEX in MIBC Treatment

FDA Accepts NDA for Roche's Giredestrant in Early-Stage ER-Positive Breast Cancer

FDA Grants Priority Review for Roche’s Tecentriq in Stage III Colon Cancer

FDA grants Priority Review for Roche’s Tecentriq in stage III colon cancer