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Apr 08, 2026
The FDA granted fast track designation to SIM0505, a CDH6-targeting antibody-drug conjugate, for platinum-resistant ovarian cancer based on preclinical and early clinical data. A phase 1 trial is currently evaluating the drug in advanced solid tumors, with initial data expected at the 2026 ASCO conference. The company plans to begin dose optimization studies in ovarian cancer patients in Q2 2026.
Apr 02, 2026
The antibody-drug conjugate sacituzumab tirumotecan demonstrated significant survival benefits in pretreated EGFR-mutated NSCLC, with median overall survival of 20.0 months versus 13.5 months for docetaxel. The treatment also showed superior progression-free survival and objective response rates with a favorable safety profile compared to chemotherapy.
Apr 01, 2026
Oncolytics Biotech received FDA Fast Track Designation for pelareorep in KRAS-mutant colorectal cancer based on data showing 33% response rate and 27-month median survival. The company is launching a Phase 2 study and recently completed reincorporation from Canada to Nevada. This marks the second Fast Track Designation for pelareorep in gastrointestinal cancers.
Mar 31, 2026
The FDA has granted Priority Review for lirafugratinib, an FGFR2 inhibitor for second-line cholangiocarcinoma treatment, with a PDUFA date of September 27, 2026. Clinical trial data showed a 46.5% objective response rate and 11.8-month median duration of response. The therapy demonstrated a manageable safety profile with lower rates of common FGFR inhibitor side effects.
Mar 28, 2026
The phase III TOP study shows osimertinib plus chemotherapy more than doubles progression-free survival to 34 months versus 15.6 months with osimertinib alone in EGFR/TP53 mutant NSCLC. The combination achieved an 82.9% response rate and represents a new strategy for this high-risk subgroup. Research continues into resistance mechanisms, including cancer-associated fibroblasts' role in promoting osimertinib resistance.
Mar 27, 2026
The FDA has approved Optune Pax, a Tumor Treating Fields device, for use with chemotherapy in locally advanced pancreatic cancer. The approval is based on phase 3 trial data showing improved overall survival and pain progression outcomes. This marks the first new treatment approach for this patient population in approximately 30 years.
Mar 19, 2026
New antibody-based approaches demonstrate clinical benefits across multiple cancer types, including improved survival in triple-negative breast cancer, enhanced tumor detection via PET imaging, and activity in relapsed mantle cell lymphoma.
Mar 15, 2026
Cogent Biosciences is preparing parallel FDA submissions for bezuclastinib across three indications following positive pivotal trial results, with potential launches beginning in late 2026 and full commercialization expected by early 2027.
Mar 12, 2026
Recent studies reveal immunotherapy failed to improve survival in small-cell lung cancer when combined with chemoradiation, while timing of immunotherapy after radiation therapy affects outcomes in non-small cell lung cancer patients.
Mar 11, 2026
Recent studies demonstrate PD-1 antibody combinations improve survival in natural killer/T-cell lymphoma and show activity in previously treated advanced non-small cell lung cancer, with manageable safety profiles across treatment settings.
Mar 03, 2026
The global oncology market is projected to nearly triple from $279.98 billion in 2026 to $748.17 billion by 2035, driven by rapid adoption of immunotherapy, checkpoint inhibitors, and cell therapies across solid tumors and hematologic cancers.
Mar 02, 2026
AIM ImmunoTech partners with Thermo Fisher to design Phase 3 trial for Ampligen in pancreatic cancer, while Innovent Biologics begins dosing patients in Phase 3 study of IBI354 for HER2-positive breast cancer.
Mar 02, 2026
Oncolytics Biotech launches Phase 2 trial of pelareorep immunotherapy in metastatic colorectal cancer, following Fast Track Designation and promising earlier results showing 27-month median survival.
Mar 02, 2026
Phase III trial demonstrates belzutifan plus lenvatinib significantly improved progression-free survival versus cabozantinib in previously treated renal cell carcinoma patients, while neoadjuvant studies show promise for locally advanced disease.
Mar 02, 2026
Phase 3 BREAKWATER trial shows encorafenib plus cetuximab and chemotherapy achieved 30.3 months median overall survival versus 15.1 months with standard therapy in previously untreated BRAF V600E-mutant metastatic colorectal cancer.
Feb 28, 2026
A prospective multicenter study found that baseline gut microbiome diversity selectively stratifies benefit from dual checkpoint blockade in advanced NSCLC, with high diversity associated with prolonged survival on immunotherapy alone while low diversity patients benefit from added chemotherapy.
Feb 27, 2026
ALX Oncology reported fourth quarter and full year 2025 financial results, highlighting validation of CD47 as a predictive biomarker for evorpacept in HER2-positive cancers and progress in its ALX2004 EGFR-targeted ADC program.
Feb 24, 2026
The FDA has granted fast track designation to ART6043 plus olaparib for germline BRCA-mutated HER2-negative breast cancer and to BriaCell's Bria-IMT plus immune checkpoint inhibitor for metastatic breast cancer, both addressing significant unmet medical needs.
Feb 21, 2026
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration BTK inhibitor regimen for CLL/SLL and cleared monthly dosing for amivantamab in EGFR-mutated NSCLC. Additional regulatory reviews are underway for PCNSL and breast cancer treatments.
Feb 26, 2026
Iovance Biotherapeutics reported Q4 2025 revenue of $87 million, beating estimates, while receiving FDA fast-track designation for lifileucel in non-small cell lung cancer and reporting strong sarcoma trial data.
