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Aug 12, 2026
At ESMO GI 2026, experts presented the EBAI framework classifying AI-based biomarkers into three validation tiers. Clinical data showed AI detecting MSI with 96-98% sensitivity and MRI-guided brachytherapy improving recurrence-free survival.
Jun 04, 2026
Dual immunotherapy allowed 70.6% of MSI-H gastric cancer patients to avoid surgery in the INFINITY trial. German off-label immunotherapy shows 20-25% response rates, requiring careful patient selection.
Jun 12, 2026
The FDA has cleared CStone Pharmaceuticals' investigational new drug application to begin a Phase II trial of its trispecific antibody CS2009 in advanced solid tumors. The multicenter trial will evaluate monotherapy and combination regimens across nine cancer types in Australia, China, and the U.S. Initial Phase I data showed a favorable safety profile and encouraging antitumor activity.
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 22, 2026
FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
May 18, 2026
Novartis reported Phase III PSMAddition data showing Pluvicto plus standard of care cut the risk of PSA progression by 58% in PSMA-positive metastatic hormone-sensitive prostate cancer. Regulatory decisions in the United States, China and Japan are expected in the second half of 2026.
Apr 22, 2026
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.
Mar 21, 2026
Trastuzumab deruxtecan is moving into earlier treatment lines for HER2-positive metastatic breast cancer, demonstrating superior efficacy over standard regimens and prompting reconsideration of long-standing treatment sequences.
Mar 10, 2026
The US FDA granted priority review and the European Medicines Agency validated applications for Enhertu as post-neoadjuvant treatment for HER2-positive early breast cancer, based on Phase III trial data showing 53% reduction in recurrence risk.
Mar 02, 2026
Final analysis of Merck's Phase 3 KEYNOTE-B96 trial shows KEYTRUDA plus paclitaxel with or without bevacizumab significantly improved overall survival in platinum-resistant recurrent ovarian cancer patients, reducing death risk by 18%.
Feb 18, 2026
The U.S. FDA granted Breakthrough Therapy Designation for subcutaneous Rybrevant Faspro as monotherapy for adults with advanced head and neck squamous cell carcinoma, based on Phase 1b/2 study data showing rapid and durable responses.
Feb 17, 2026
The FDA has approved a monthly dosing schedule for Rybrevant Faspro in EGFR-mutated NSCLC and granted breakthrough therapy designation for the drug as monotherapy in HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma after prior therapy.
Feb 16, 2026
CStone Pharmaceuticals has received FDA clearance for its IND application to initiate a Phase II trial of CS2009, a trispecific antibody targeting PD-1, VEGFA, and CTLA-4, in patients with advanced solid tumors across nine cancer indications.
Feb 16, 2026
CStone Pharmaceuticals received FDA IND clearance to initiate a Phase II trial of CS2009, a PD-1/VEGF/CTLA-4 trispecific antibody, in patients with advanced solid tumors across nine cancer indications.
Feb 16, 2026
CStone Pharmaceuticals received FDA IND clearance to begin a Phase II trial of CS2009, a trispecific antibody targeting PD-1, VEGF, and CTLA-4, in advanced solid tumors across nine cancer indications.
Feb 15, 2026
Alphamab Oncology dosed the first patient in its Phase III trial of JSKN003, a biparatopic HER2-targeting antibody-drug conjugate, for HER2-positive advanced colorectal cancer on February 14, 2026.
Feb 14, 2026
Alphamab Oncology has dosed the first patient in a Phase III study of JSKN003, a biparatopic HER2-targeting ADC, for HER2-positive advanced colorectal cancer. The drug demonstrated a 68.8% response rate in earlier trials.
Dec 18, 2025
The FDA approved a once-monthly dosing schedule for Rybrevant Faspro with Lazcluze for first-line treatment of EGFR-mutated advanced NSCLC, reducing clinic visits while maintaining safety and efficacy established with bi-weekly dosing.
Feb 12, 2026
The FDA approved pembrolizumab (Keytruda) and Keytruda Qlex plus paclitaxel, with or without bevacizumab, for adults with PD-L1+ platinum-resistant ovarian carcinoma based on Phase 3 trial data showing improved survival outcomes.
