Bayer Reports the US FDA’s Approval of Lynkuet (Elinzanetant) to Treat Vasomotor Symptoms

Shots: The US FDA has approved Lynkuet for the treatment of mod. to sev. vasomotor symptoms due to menopause based on P-III (OASIS-1, 2, & 3) trials, with commercial availability expected at the start of Nov 2025; MAA is under the EMA’s review Efficacy was evaluated in OASIS-1 & 2 trials assessing Lynkuet vs PBO…

ByRidhi RastogiOctober 27, 2025

NEWS

Bayer Reports the CHMP’s Positive Opinion of Elinzanetant to Treat Vasomotor Symptoms

Shots: The CHMP has recommended elinzanetant for treating mod. to sev. vasomotor symptoms linked with menopause or caused by AET related to breast cancer based on P-III (OASIS-1, 2, 3 & 4) trials OASIS-1 & 2 showed reduced mod. to sev. menopausal VMS vs. PBO at wks. 4 & 12, with >80% pts (incl. those…

ByRidhi RastogiSeptember 23, 2025

NEWS

Bayer Presents P-III (OASIS 4) Study Data of Elinzanetant for Vasomotor Symptoms (VMS) Associated with Breast Cancer Therapies at ASCO 2025

Shots: The P-III (OASIS-4) study evaluated elinzanetant (120mg, PO, QD) vs PBO for 52wks. to treat mod. to sev. VMS associated with endocrine therapy for treatment or prevention of HR+ breast cancer, with an optional 2yr. extension; regulatory filings are ongoing in the US, EU & other regions Trial showed reduced VMS frequency (1EP), with…

ByRidhi RastogiJune 3, 2025

NEWS

Bayer Reports Topline Data from P-III (OASIS 4) Study of Elinzanetant to Treat Vasomotor Symptoms (VMS) Associated with Breast Cancer Therapies

Shots: The P-III (OASIS 4) study assessed elinzanetant (oral, QD) vs PBO for 52wks. to treat mod. to sev. VMS caused by endocrine therapy in women (n=474) & for another 2yrs. for those with or at high risk of HR+ breast cancer The study achieved its 1EP of VMS severity reduction at 4 &…

ByRidhi RastogiJanuary 10, 2025

Bayer Reports the US FDA’s Approval of Lynkuet (Elinzanetant) to Treat Vasomotor Symptoms

Bayer Reports the CHMP’s Positive Opinion of Elinzanetant to Treat Vasomotor Symptoms

Bayer Presents P-III (OASIS 4) Study Data of Elinzanetant for Vasomotor Symptoms (VMS) Associated with Breast Cancer Therapies at ASCO 2025

Bayer Reports Topline Data from P-III (OASIS 4) Study of Elinzanetant to Treat Vasomotor Symptoms (VMS) Associated with Breast Cancer Therapies

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