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Jul 02, 2026
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.
Aug 05, 2026
Clarity Pharmaceuticals announced preliminary SECuRE trial results showing 74% of participants achieved PSA25 and 81% disease control with 8 GBq 67Cu-SAR-bisPSMA. A 76-year-old patient achieved undetectable disease after two cycles, and shares rose 14%.
Feb 24, 2026
Real-world analyses of Novartis' Pluvicto show a median PFS of 13.5 months in taxane-naive mCRPC patients, with better outcomes when used after one ARPI. Additional data indicate subsequent therapies remain effective after Pluvicto, while a separate analysis found gaps in guideline-adherent treatment for mHSPC.
Jun 30, 2026
PCF invests $6.3M in 31 Young Investigator Awards, supports Creativity Awards, and hosts Home Run Challenge 2026 to raise awareness. The foundation has contributed to 15 FDA-approved therapies over its 30-year history.
Jun 15, 2026
The FDA has cleared an IND for Amphista's novel BRD9 degrader AMX-883 for AML, approved Lantheus' new prostate cancer imaging agent Pylarify TruVu, and accepted Biofrontera's sNDA for Ameluz PDT in superficial basal cell carcinoma. These regulatory milestones span hematologic and solid tumor areas, addressing significant unmet medical needs.
Jun 08, 2026
Novartis expands US radioligand manufacturing with new Texas and North Carolina facilities to bolster domestic production of cancer treatments. Telix Pharmaceuticals reports positive Phase 3 prostate cancer trial data and maintains 2026 revenue guidance of US$950-970 million.
Jun 05, 2026
Key oncology developments include a $315 million partnership between Astellas and Vir for the prostate cancer T-cell engager VIR-5500, with updated phase 1 data showing an 82% PSA50 rate. The FDA accepted a filing for Ono Pharmaceuticals' tirabrutinib seeking accelerated approval in primary central nervous system lymphoma. Research findings also identified a new kidney cancer biomarker and showed promising results for the TRK inhibitor repotrectinib and the breast cancer triple therapy gedatolisib plus palbociclib and fulvestrant.
Jun 01, 2026
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.
May 16, 2026
Phase 2 Co-PSMA trial shows 64Cu-SAR-bisPSMA PET/CT detected 63 prostate cancer lesions vs 24 with 68Ga-PSMA-11, with 78% vs 36% positive scans. Results changed management in 44% of patients.
May 12, 2026
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.
May 04, 2026
The radioligand therapeutics market in cancer treatment is estimated to grow from $2.6 billion in 2025 to $4.8 billion by 2030 at a 13.1% CAGR. Growth is supported by approved products Pluvicto and Lutathera and expanding use of PSMA and SSTR-targeted therapies.
Apr 14, 2026
Vir Biotechnology has dosed the first patient in a Phase I VIR-5500 expansion cohort for metastatic prostate cancer. The trial is evaluating VIR-5500 as monotherapy and in combination settings across mCRPC and mHSPC.
Apr 06, 2026
Phase 3 PSMAddition showed that adding 177Lu-PSMA-617 to ADT plus an ARPI improved radiographic progression-free survival in PSMA-positive mHSPC. Health-related quality of life and pain were largely maintained.
Mar 12, 2026
The global radioligand therapy market is projected to grow from $2.6 billion in 2025 to $4.8 billion by 2030 at 13.1% CAGR, driven by FDA label expansions, earlier-line treatment positioning, and substantial private investment in isotope production infrastructure.
Feb 28, 2026
Pluvicto (lutetium-177 vipivotide tetraxetan) received MHRA authorization for earlier use in metastatic castration-resistant prostate cancer, while pooled trial data demonstrates improved progression-free survival without increased toxicity.
Feb 24, 2026
Vir Biotechnology reported Q4 EPS of ($0.31), beating estimates by $0.23, with revenue of $64.07 million. The company announced a global strategic collaboration with Astellas for VIR-5500 and reported $781.6 million in cash and investments.
Feb 24, 2026
Vir Biotechnology announced a global strategic collaboration with Astellas for VIR-5500, a PSMA-targeted dual-masked T-cell engager for prostate cancer, and reported $781.6 million in cash and investments as of December 31, 2025.
Feb 23, 2026
Another participant with metastatic castration-resistant prostate cancer achieved undetectable PSA and negative PSMA PET after treatment with 67Cu-SAR-bisPSMA in the SECuRE trial. This marks the fifth patient to achieve undetectable disease by radiographic assessment in Clarity Pharmaceuticals' program.
Feb 16, 2026
The FDA is set to announce decisions in March 2026 on several drug applications, including label expansions for approved therapies and new drug candidates, with some making repeat approval attempts.
Feb 18, 2026
Flatiron Health announced its first Panoramic datasets for prostate cancer patients in the UK and Germany, encompassing records of nearly 400,000 patients across three countries. The datasets leverage AI and large language models to provide unified real-world evidence for cancer research.
