Biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), announced on Friday that the US Food and Drug Administration (FDA) has accepted its New Drug Application for investigational oral giredestrant plus everolimus to treat adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer after prior endocrine therapy.
The agency set a Prescription Drug User Fee Act action date of 18 December 2026. The combined regimen could become the first oral selective oestrogen receptor degrader combination approved in the post-CDK4/6 inhibitor setting.
Acceptance of the filing is supported by Phase III evERA results showing the combination reduced risk of disease progression or death by 44% in the intention-to-treat (ITT) population and 62% in ESR1-mutated patients versus standard endocrine therapy plus everolimus.
HanchorBio's HCB101 receives US FDA Orphan Drug Designation in gastric cancer
STADA and Bio-Thera Solutions receive European marketing authorisation for Gotenfia (golimumab)
MEDIPOST files IND amendment to start Phase III trial for knee osteoarthritis therapy
DifGen Pharmaceuticals' Fluorometholone Ophthalmic Suspension, 0.1% receives FDA approval
Philips launches InkSpace Imaging Snuggle coil for 3.0T MRI systems
Amgen wins European approval for Uplizna in generalised myasthenia gravis
Arctic Therapeutics enrols first patients in Phase IIa trial of AT-004 for acne vulgaris
BillionToOne launches two new add-on liquid biopsy applications for Northstar Select
Iterion Therapeutics reports first patient dosed in clinical study of tegavivint
FDA accepts Takeda's oveporexton NDA with priority review for narcolepsy type 1
Innocan Pharma reports findings from clinical study of LPT-CBD in dogs
Lunai Bioworks starts new oncology collaboration with clinical-stage partner
Median Technologies secures FDA clearance for AI lung cancer screening software
Sanofi's rilzabrutinib receives FDA breakthrough and Japan orphan designations for rare anaemia