ALPMY News & Events

Pfizer (PFE) and Astellas Pharma (ALPMY announced that the U.S. Food and Drug Administration has approved PADCEV, a Nectin-4 directed antibody-drug conjugate, in combination with the PD-1 inhibitor Keytruda or Keytruda QLEX, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy.i The approval of this perioperative treatment was based on results from the pivotal Phase 3 EV-303 clinical trial, which were presented during a Presidential Symposium at the European Society of Medical Oncology Congress 2025.

Astellas Pharma announced new real-world preliminary data from the OPTION-VMS Phase IV, longitudinal, observational study, providing the first insights into the real-world use of fezolinetant. The data demonstrated statistically significant improvements in VMS bother related to menopause, statistically significant improvements in subjective and objective sleep outcomes and significant improvements in activity impairment including overall work productivity. VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause. These preliminary data will be presented this week as late-breaker poster presentations at The Menopause Society 2025 Annual Meeting in Orlando, Florida. The preliminary analysis of the study of more than 900 women aged 40-75 years with confirmed menopausal VMS, who were prescribed a non-hormonal therapy, or non- HT, for the treatment of bothersome VMS, met its primary endpoint and other endpoints selected for this preliminary data cut. Women prescribed fezolinetant demonstrated: Statistically significant improvements in VMS bother related to menopause as measured by reductions in Menopause-Specific Quality of Life, or MENQOL, VMS domain scores at week 12 and at weeks 4 and 8. Statistically significant improvements were demonstrated at weeks 4, 8, and 12 in Total T scores, an overall measure of how menopause symptoms affect quality of life, and additional MENQOL domain scores, reflecting the categories of the total patient reported outcome measures including sexual, psychosocial and physical. Statistically significant reductions were observed at weeks 4, 8, 12 in patient reported sleep quality as measured by PROMIS SD SF 8b Total T scores. Statistically significant improvements in objective sleep outcomes based on actigraphy endpoints including wakefulness after sleep onset at weeks 4, 8, 12, and sleep efficiency at weeks 4 and 12. Incidence of fezolinetant-related treatment-emergent adverse events in the study were low and consistent with clinical trials and post marketing data. No new safety signals were observed. Preliminary safety findings will be presented at The Menopause Society, with full results available after final analysis.

Astellas Pharma announced that the U.S. Food and Drug Administration accepted for priority review a supplemental Biologics License Application for PADCEV in combination with KEYTRUDA as a neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy. Under the Prescription Drug User Fee Act, the FDA has set a target action date of April 7, 2026.

Astellas Pharma announced the first results from the open-label extension trial of the Phase 3 GATHER2 study, which demonstrated monthly treatment with IZERVAY in patients with geographic atrophy, GA, secondary to age-related macular degeneration, AMD, continued to reduce GA lesion growth for up to 3.5 years, with earlier intervention resulting in greater protection of retinal tissue area. IZERVAY was well tolerated, with no cases of retinal vasculitis or occlusive vasculitis. These findings, which indicate a cumulative treatment benefit with IZERVAY, were presented at the American Academy of Ophthalmology 2025 Annual Meeting during the Retina Subspeciality Day in Orlando, Fla. In GATHER2 open-label extension study, IZERVAY reduced GA growth 37-40.5% vs. projected sham, with earlier intervention resulting in greater protection of retinal tissue area .