The FDA approved six cancer therapies in Q2 2026, including first-line sacituzumab govitecan for triple-negative breast cancer and capivasertib for PTEN-deficient prostate cancer. A separate study shows 69% of accelerated-approval cancer drugs need safety updates within 4 years.
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.
The FDA has approved three new targeted therapies for different stages of advanced prostate cancer: Truqap for PTEN-deficient tumors, rucaparib for BRCA-mutated castration-resistant disease, and Akeega for BRCA2-mutated castration-sensitive cancer.
At the ADA Scientific Sessions, Novo Nordisk's Wegovy pill surpassed 3 million prescriptions within five months, while Structure Therapeutics and AstraZeneca shared mid-stage GLP-1 data targeting a 2029 launch. The US FDA approved TRUQAP as the first targeted treatment for PTEN-deficient metastatic prostate cancer, reducing disease progression risk by 19% in the CAPItello-281 trial. Meanwhile, two major genomic atlas projects—a 4,098-genome infant gut bacteria catalog and Basecamp Research's Trillion Gene Atlas—aim to advance precision probiotics and AI-driven drug discovery, respectively.
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.
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.
PARP inhibitors remain strongest in BRCA1/2-altered tumors as use beyond that group has been uneven. In June 2025, the FDA narrowed Zejula’s first-line ovarian maintenance indication to HRD-positive tumors only.
Multiple pharmaceutical companies have initiated clinical trials for metastatic castration-resistant prostate cancer in February 2026, with over 180 companies developing 200+ pipeline therapies. Studies include combination therapies and novel drug candidates targeting advanced disease.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| 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 |
| NCT07641855 |
A Study of BL-B01D1 Combination Therapy in Patients With Metastatic Castration-resistant Prostate Cancer |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07620574 |
Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study |
NOT_YET_RECRUITING | PHASE3 |
| NCT07611110 |
AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) |
RECRUITING | PHASE3 |
| 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 |
| NCT07287150 |
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer |
RECRUITING | PHASE2 |
| NCT07226986 |
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC |
RECRUITING | PHASE1/PHASE2 |
| NCT07190300 |
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) |
RECRUITING | PHASE1/PHASE2 |
| NCT07140900 |
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer |
RECRUITING | PHASE1 |
| NCT06991556 |
An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) |
RECRUITING | PHASE2 |
