Astellas co-owns Padcev and makes Vyloy, the first Claudin 18.2 drug.
Astellas, based in Tokyo and listed as 4503.T, co-owns Padcev with Pfizer and makes Vyloy, or zolbetuximab, the first Claudin 18.2 drug, approved in 2024. Its oncology portfolio also includes enzalutamide, shared with Pfizer, and gilteritinib for FLT3-mutated acute myeloid leukaemia, and OnCo links it to the EV-302 paper that made enfortumab vedotin plus pembrolizumab the first-line standard in advanced bladder cancer, to SPOTLIGHT for zolbetuximab in gastric cancer and to ADMIRAL for gilteritinib. Its cancer pages cover bladder, gastric, prostate and acute myeloid leukaemia. Whether Claudin 18.2 becomes a broad target class, with ADCs and CAR-Ts following the antibody, is the question zolbetuximab opened. Enfortumab vedotin has its own page.
Enfortumab vedotin is an ADC against Nectin-4 that, combined with pembrolizumab, nearly doubled survival in advanced bladder cancer.
Setidegrasib is an experimental investigational agent whose form is not stated in the registry from Astellas Pharma Global Development in phase 3 trials for pancreatic ductal adenocarcinoma and non-small-cell lung cancer, aimed at KRAS.
ASP2138 is an experimental bispecific antibody from Astellas Pharma Global Development in phase 3 trials for gastric & gastro-oesophageal junction cancer, aimed at Claudin 18.2 and CD3.
XNW27011 is an experimental antibody-drug conjugate from Astellas Pharma Global Development in phase 2 trials for pancreatic ductal adenocarcinoma, non-small-cell lung cancer and ovarian cancer, aimed at Claudin 18.2.
Enzalutamide is a second-generation androgen-receptor blocker that stops the receptor binding testosterone, entering the nucleus and switching on genes. It is approved at every stage of advanced prostate cancer, from rising PSA after surgery to castration-resistant disease, and fatigue, falls and memory problems are its main drawbacks.
Erlotinib was one of the first EGFR pills for lung cancer; it was approved before anyone knew EGFR mutations predicted who would respond, then redefined by them.
A single pill that beats salvage chemotherapy for relapsed FLT3-mutated AML, and the backbone of the triplets now being tested in frontline disease.
Zolbetuximab is the first drug against Claudin 18.2, a protein exposed on stomach cancer cells. Added to chemotherapy it extends survival by two to three months; nausea is the price.
Almost every patient newly diagnosed with advanced bladder or urothelial cancer should now be offered enfortumab vedotin plus pembrolizumab rather than chemotherapy, with median survival extended from about 16 months to over two and a half years. Neuropathy and skin toxicity need monitoring and dose adjustment, and patients with severe diabetes or pre-existing neuropathy need care. Platinum chemotherapy remains an option for those who cannot receive the combination.
Patients with newly diagnosed advanced stomach cancer should now have Claudin 18.2 tested alongside HER2, PD-L1 and mismatch repair, because roughly a third will be eligible for zolbetuximab, which adds about three months of median survival. The main practical problem is nausea and vomiting during infusions, which needs aggressive prophylaxis. How to sequence or combine it with immunotherapy in PD-L1-positive tumours is unresolved.
ADMIRAL showed that a targeted oral drug can beat chemotherapy outright in relapsed AML, and made gilteritinib the standard bridge to transplant for FLT3-mutated relapse. Its success also underpinned FLT3 inhibitor use in first-line combinations. Resistance through FLT3-independent clones and RAS pathway mutations limits durability without transplant.
The trial that made an androgen receptor inhibitor the usual first treatment for castration-resistant prostate cancer, and that delayed chemotherapy by a long margin for most men. Its effect sizes are why later trials in this setting are judged against a hazard ratio near 0.7 for survival.
An oral drug that works after chemotherapy has failed, in a disease where the previous option was more chemotherapy. Together with abiraterone it moved castration-resistant prostate cancer from a chemotherapy disease to a hormonal one, and set up the sequencing questions the field is still arguing about.
Shares EV-304 / KEYNOTE-B15, EV-303 / KEYNOTE-905, EV-302 / KEYNOTE-A39, Enfortumab vedotin.
Shares A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors, ASP2138, SPOTLIGHT & GLOW, SPOTLIGHT: zolbetuximab, the first Claudin 18.2 antibody, added to chemotherapy in gastric cancer.
Shares EV-304 / KEYNOTE-B15, EV-303 / KEYNOTE-905, EV-302: enfortumab vedotin plus pembrolizumab replaces chemotherapy as first treatment for advanced bladder cancer, Enfortumab vedotin.
Shares A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation, ADMIRAL, MORPHO, ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia.
Shares An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormo, A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study, Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC, PROSPER.
Shares A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202), Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer, A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder, Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC.
Shares ASP2138, XNW27011, SPOTLIGHT & GLOW, SPOTLIGHT: zolbetuximab, the first Claudin 18.2 antibody, added to chemotherapy in gastric cancer.