ASTELLAS PHARMA UNSP/ADR - ALPMY STOCK NEWS

Astellas Pharma announced that Japan's Ministry of Health, Labour and Welfare has granted priority review for its New Drug Application (NDA) for enfortumab vedotin, submitted in March. If approved, it will be Japan's first antibody-drug conjugate for treating locally advanced or metastatic urothelial cancer after other therapies. The NDA includes data from global phase 3 EV-301 and phase 2 EV-201 trials. Approximately 9,500 people die from urothelial cancer annually in Japan, highlighting the urgent need for new treatments.

Astellas Pharma announced that the European Commission approved XTANDI™ (enzalutamide) for treating metastatic hormone-sensitive prostate cancer (mHSPC). This approval follows the Phase 3 ARCHES trial, which demonstrated a 61% reduction in the risk of radiographic progression or death when enzalutamide was combined with androgen deprivation therapy. XTANDI is now the only oral treatment available in the EU for this type of advanced prostate cancer, providing a crucial therapeutic option. The approval does not affect Astellas' financial forecasts for the current fiscal year ending March 31, 2022.

Astellas Pharma and Seagen announced the FDA's acceptance of two supplemental Biologics License Applications (sBLA) for PADCEV (enfortumab vedotin-ejfv) under the Real-Time Oncology Review pilot program. Both applications received Priority Review, aimed at ensuring timely access to safe treatments. The first sBLA seeks to convert accelerated approval to regular approval, while the second expands PADCEV's indication for patients with advanced urothelial cancer. Target action date for both is August 17, 2021.

Astellas Pharma announced that its Phase 3 COMMODORE trial of XOSPATA (gilteritinib) in relapsed or refractory FLT3 mutation-positive acute myeloid leukemia (AML) met its primary endpoint of overall survival compared to chemotherapy. The trial, conducted in China and other countries, has halted enrollment, offering patients in the chemotherapy arm gilteritinib. Earlier this year, the NMPA granted conditional approval for gilteritinib in China, and Astellas plans to submit trial results for full approval. Gilteritinib demonstrated safety in previous trials with frequent adverse reactions including ALT and AST increases.

Astellas Pharma announced FDA approval of Myrbetriq (mirabegron) for treating neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older, weighing at least 35 kg. This includes two formulations: Myrbetriq extended-release tablets and Myrbetriq Granules, the latter set for U.S. availability by the end of 2021. The approval also grants an additional six months of market exclusivity. NDO is often linked to spina bifida, affecting urinary control. This approval reflects Astellas' commitment to enhancing urologic health for vulnerable populations.

Astellas Pharma has received a positive opinion from the European Medicines Agency's CHMP for XTANDI (enzalutamide) to treat metastatic hormone-sensitive prostate cancer (mHSPC). This oral therapy addresses a significant unmet medical need, as mHSPC has a median survival of about 3-4 years. If approved by the European Commission, enzalutamide will be the only oral treatment for three types of advanced prostate cancer. The decision is based on favorable results from the Phase 3 ARCHES trial, where enzalutamide plus androgen deprivation therapy significantly reduced the risk of disease progression.

Astellas Pharma and Seagen announced the acceptance of a marketing authorization application (MAA) for **enfortumab vedotin** by the **European Medicines Agency (EMA)** for treating advanced urothelial cancer. This therapy is aimed at adults who have previously undergone treatment with PD-1 or PD-L1 inhibitors and platinum-based chemotherapy. If approved, it will be the first **antibody-drug conjugate (ADC)** available in the European Union for this condition. The MAA is based on the **global phase 3 EV-301 trial**, which showed promising results compared to chemotherapy.

Astellas Pharma announced positive topline results from the Phase 3 SKYLIGHT 1 and SKYLIGHT 2 trials for fezolinetant, a nonhormonal treatment for moderate to severe vasomotor symptoms (VMS) in menopausal women. Both trials demonstrated significant reductions in the frequency and severity of VMS compared to placebo. Serious treatment-emergent adverse events were minimal. These studies are crucial for evaluating the safety of fezolinetant over 52 weeks, with detailed results forthcoming. If approved, fezolinetant would be a first-in-class option for VMS.

Astellas and Seagen have completed submissions for two supplemental Biologics License Applications (sBLAs) to the FDA for PADCEV (enfortumab vedotin-ejfv). One seeks to convert its accelerated approval to regular approval based on the EV-301 trial data, while the second aims for label expansion to include patients with metastatic urothelial cancer previously treated with a PD-1/L1 inhibitor. The FDA is reviewing these applications under the Real-Time Oncology Review pilot program, which aims for expedited access to effective treatments.