Also known as: Xtandi, XTANDI
Enzalutamide is an oral nonsteroidal antiandrogen marketed as Xtandi for castration-resistant and castration-sensitive prostate cancer settings in combination with castration. It is a second-generation androgen receptor pathway inhibitor with U.S. and EU prescription-only status. The therapy was introduced for prostate cancer in 2012.
Astellas Pharma reported fiscal 2026 sales of ¥2.14 trillion and net income of ¥291.54 billion, alongside an FDA Priority Review for PADCEV plus Keytruda in muscle-invasive bladder cancer. The company also settled U.S. Myrbetriq patent disputes with Lupin and Zydus. Shares trade at ¥2,470 with mixed valuation signals.
China's 12th national Volume-Based Procurement round places RMB 60 billion across 65 drug varieties, accelerating generics and biosimilars substitution. Separately, Genialis launched BioBridge to help translate Chinese oncology trial results into Western development programs, as Chinese out-licensing hit $137.7 billion in 2025.
Telix gained FDA alignment to advance ProstACT Global Phase 3 into U.S. Part 2 for TLX591-Tx in mCRPC, with safety data from Part 1 deemed sufficient. The trial will combine the therapy with abiraterone, enzalutamide, or docetaxel, pending IND amendment review.
Recent prostate cancer research includes a Phase 2 trial of opaganib in advanced disease, a SEER study linking older age to higher mortality in bone-only metastases, and AI and genetic tools that improve detection.
Global oncology drug spending is projected to reach $467 billion by 2030, driven by novel modalities like ADCs and bispecifics, but growth will slow due to patent expirations for key drugs like Keytruda and Lynparza. R&D is shifting, with novel modalities accounting for 33% of clinical trials in 2025. The industry is also seeing broader innovation and investment, with new blockbuster contenders emerging across multiple therapeutic areas.
European guidelines now recommend lutetium-177 PSMA-617 for advanced prostate cancer, while a machine-learning model predicts treatment radiation dose. A study finds DOACs safe with modern prostate cancer drugs.
The FDA has approved Pfizer's BRAFTOVI for BRAF V600E metastatic colorectal cancer and VEPPANU for ESR1 mutated breast cancer. The oncolytic virus cancer therapy pipeline expands with over 120 companies developing 125+ drugs. Positive late-stage data for other Pfizer oncology programs was also reported.
A post hoc STAMPEDE analysis found lower on-treatment PSA levels were strongly associated with improved long-term survival in advanced prostate cancer, but disease burden still affected outcomes.
Telix said Part 1 of the ProstACT Global Phase 3 study met its primary objectives for TLX591-Tx in mCRPC. The company reported acceptable safety, no new safety signals and progression plans for Part 2.
ORIC selected rinzimetostat 400 mg plus darolutamide for the Himalayas-1 Phase 3 trial in post-abiraterone mCRPC, expected to start in 1H 2026. The company reported early efficacy and safety data and said cash runway extends into 2H 2028.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07723248 |
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1) |
RECRUITING | PHASE3 |
| NCT07711002 |
Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05) |
NOT_YET_RECRUITING | PHASE3 |
| NCT07620574 |
Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study |
ENROLLING_BY_INVITATION | PHASE3 |
| NCT07611110 |
AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) |
RECRUITING | PHASE3 |
| NCT07592910 |
A Study of Mevrometostat With Enzalutamide in People With Prostate Cancer Who Have Previously Received Androgen Receptor Pathway Inhibitor Therapy |
NOT_YET_RECRUITING | PHASE2 |
| NCT07570979 |
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer |
RECRUITING | PHASE1 |
| NCT07428642 |
PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC. |
COMPLETED | |
| NCT07406282 |
A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics |
RECRUITING | |
| NCT07287150 |
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer |
RECRUITING | PHASE2 |
| NCT07277270 |
A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors |
RECRUITING | PHASE1 |
