Obstetrics and gynecology ·
FDA grants elinzanetant priority review; vanishing twin pregnancy codes take effect; real-world data tie fezolinetant to better sleep
THE SHORT READ
The Food and Drug Administration (FDA) granted priority review to elinzanetant for hot flashes in women taking endocrine therapy for breast cancer, Bayer said Sept. 28. New ICD-10-CM codes for continuing pregnancy after vanishing twin syndrome took effect Oct. 1. Real-world data presented at the International Menopause Society's World Congress tied fezolinetant to improved sleep and vasomotor symptom scores from week 4, according to Contemporary OB/GYN.
THE DETAILS
- FDA Sept 28, 2026Bayer said Sept. 28 that the Food and Drug Administration accepted its supplemental new drug application for Lynkuet (elinzanetant) to treat moderate to severe vasomotor symptoms in women receiving endocrine therapy to treat or prevent hormone receptor-positive breast cancer. The application rests on the phase 3 OASIS-4 trial, which randomized 474 women 2:1 to elinzanetant for 52 weeks or to placebo for 12 weeks followed by elinzanetant. The drug was first approved in the U.S. in October 2025 for menopause-related vasomotor symptoms.Sources: Bayer, Contemporary OB/GYN
- Payment Oct 1, 2026The fiscal 2027 code set, which the Centers for Disease Control and Prevention (CDC) says applies to services from Oct. 1, 2026, through Sept. 30, 2027, adds 190 codes, deletes 30 and revises four, according to AGS Health. Category O31.4, continuing pregnancy after vanishing twin syndrome of one fetus or more, accounts for 33 of the new codes, AGS Health said. Vanishing twin syndrome is the loss or resorption of one embryo in a multiple gestation.
- Research Oct 1, 2026Data from OPTION-VMS, an ongoing phase 4 observational study of women aged 40 to 75 prescribed nonhormonal therapy for menopausal vasomotor symptoms, were presented at the International Menopause Society's World Congress on Menopause and announced by Astellas, the drug's maker. Among women taking fezolinetant 45 mg, MENQOL vasomotor domain scores and patient-reported sleep disturbance improved from baseline at weeks 4, 8 and 12 (P < .001), according to Contemporary OB/GYN. Wakefulness after sleep onset, sleep efficiency and sleep latency also improved from baseline (P < .05), and nighttime awakenings fell by a mean 2.6 at week 12.Source: Contemporary OB/GYN
The weekly roundup for obstetrics and gynecology, published every Monday for the week before; every item links to its sources. Latest obstetrics and gynecology news · All specialties