ASTELLAS PHARMA UNSP/ADR - ALPMY STOCK NEWS

Astellas Pharma and Seagen announced that the FDA granted regular approval for PADCEV® (enfortumab vedotin-ejfv) for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin chemotherapy. This approval follows its accelerated approval in 2019 and is based on data from the Phase 3 EV-301 trial, which demonstrated a median overall survival of 12.9 months for PADCEV versus 9.0 months for chemotherapy. The drug offers an important treatment option for patients with limited therapies and poor prognosis.

Astellas Pharma and FibroGen announced a positive opinion from the European Medicines Agency's CHMP for roxadustat, aimed at treating symptomatic anemia in chronic kidney disease (CKD) patients. This potential approval would make roxadustat the first oral HIF-PH inhibitor in Europe. The CHMP's positive stance is based on a Phase 3 program involving 9,600 patients, demonstrating effectiveness in increasing hemoglobin levels and a safety profile comparable to existing treatments. The European Commission will review the opinion within 67 days for a final decision.

Astellas Pharma presented new data in acute myeloid leukemia (AML) at the European Hematology Association (EHA) virtual congress from June 9-17. Eight Astellas-sponsored abstracts were showcased, including two oral presentations and four posters. The research underscores patient and physician preferences for treatment strategies post-hematopoietic stem cell transplantation and evaluates gilteritinib's efficacy in treating FLT3 mutation-positive AML. The presentation emphasizes Astellas' commitment to advancing AML research with ongoing evaluations of treatment combinations.

Astellas Pharma and Seagen have announced updated results from two clinical trials involving PADCEV® (enfortumab vedotin-ejfv). The EV-201 study showed a 51% objective response rate in patients with advanced urothelial cancer who were ineligible for cisplatin, with a median overall survival of 16.1 months. The EV-103 trial, testing PADCEV with Merck's KEYTRUDA®, reported a 73.3% objective response rate and a median overall survival of 26.1 months. The FDA has granted Priority Review for PADCEV based on these results.

Astellas Pharma will present new oncology data at the 2021 ASCO Annual Meeting from June 4-8, focusing on treatments for hard-to-treat cancers such as bladder and prostate cancers, along with acute myeloid leukemia. The company will showcase 12 abstracts, underlining its commitment to addressing unmet medical needs. Notable presentations will include quality of life results from the EV-301 trial and analyses on racial disparities in prostate cancer treatment. Astellas collaborates with Seagen and Merck on some therapies, illustrating its partnership-driven approach to advancing cancer treatment.

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.