ASTELLAS PHARMA EUROPE LTD.

Study on MM treatment decision-making highlights QoL, duration of response, and side effects as top attributes for patients, care partners, and physicians. Differences in preferences and trade-offs underscore the importance of shared decision-making (SDM) to align treatment plans with patient values and improve outcomes.

Bayer seeks EMA approval for elinzanetant, a non-hormonal menopause drug targeting hot flashes, challenging Astellas’ Veozah. Success in Phase III trials could redefine treatment options, offering safer alternatives to hormone therapy.

Biopharma updates in Asia-Pacific: deals, partnerships, grants, preclinical data, and other briefs involving Alkem, Aosaikang, Astellas, Bio-thera, Ciconia Bioventures, Gedeon Richter, Innovent, Sonnet, Sumitomo Mitsui, Takeda.

Bayer submitted a marketing authorisation application to the EMA for its menopause treatment elinzanetant, indicated for moderate to severe hot flashes, including those from adjuvant endocrine therapy. The submission follows an FDA acceptance of Bayer's NDA for elinzanetant. Elinzanetant, a non-hormonal therapy, demonstrated efficacy and safety in Phase III OASIS trials, reducing hot flash frequency and improving sleep and quality of life. Bayer aims to offer personalized care for menopausal symptoms, positioning elinzanetant to compete with Astellas' Veozah.

UK High Court upheld patent EP 1 893 196 for enzalutamide, rejecting generics' claim of obviousness. The patent, owned by UC Regents and licensed to Astellas, covers the prostate cancer drug Xtandi. Parallel proceedings are pending in Europe.

Pfizer's phase 3 TALAPRO-2 trial shows significant OS improvement with Talzenna (PARP inhibitor) and Xtandi (ARPI) in metastatic castration-resistant prostate cancer (mCRPC), regardless of HRR gene mutation status. The combination's safety profile remains consistent with individual drugs, and the data will support potential label expansion.

A personalized dose-escalated radiotherapy (RT) strategy for bladder cancer showed low severe late toxicity and survival rates comparable to cystectomy, according to a randomized trial. Only one case of grade ≥3 late toxicity occurred among 114 patients treated with dose-escalated adaptive RT (DART), with 2-year overall survival at 80% for DART and 77% for standard RT. The study highlights the potential of personalized RT to offer a more effective treatment option for bladder cancer.

Merck & Co’s Keytruda and Astellas/Pfizer’s Padcev approved by MHRA as first-line treatment for advanced bladder cancer, based on KEYNOTE-A39/EV-302 trial results showing 53% reduction in risk of death and extended progression-free survival.

Biopharma updates: deals, partnerships, grants, preclinical data, and other news involving Alkem, Astellas, Bio-Thera, Boehringer, Ciconia, Circle Pharma, Eli Lilly, Gedeon Richter, Gemma, Insitro, Johnson & Johnson, Nona, Overt Bio, Qinotto, Sonnet, Sumitomo, Takeda, Xortx.