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 06, 2026
The FDA approved Tecvayli plus Darzalex Faspro for relapsed or refractory multiple myeloma after at least one prior therapy, and accepted a new drug application for iberdomide plus daratumumab and dexamethasone with a PDUFA date of August 17, 2026.
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.
Feb 28, 2026
New CAR T-cell approaches targeting BCMA and CD19 simultaneously show encouraging early results, while researchers develop control strategies for CAR-T therapies including antibody-drug conjugates.
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 26, 2026
New combination therapies demonstrate improved outcomes in advanced anal and colorectal cancers, with retifanlimab plus chemotherapy approved for anal cancer and onvansertib showing strong efficacy signals in RAS-mutated colorectal cancer.
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 20, 2026
Phase 2 trial data show lisocabtagene maraleucel achieved a 95% overall response rate in patients with relapsed or refractory marginal zone lymphoma, with a manageable safety profile and no new safety signals.
Feb 18, 2026
NovaBridge Biosciences has enrolled the first patient in a global Phase 2 study evaluating givastomig in combination with nivolumab and chemotherapy for HER2-negative, first-line metastatic gastric cancer, with top-line results expected in 2027.
Feb 18, 2026
The FDA has accepted a new drug application for tirabrutinib, a BTK inhibitor, for relapsed/refractory primary central nervous system lymphoma under the accelerated approval pathway. The regulatory agency set a PDUFA target action date of December 18, 2026.
Feb 17, 2026
The U.S. FDA has accepted Bristol Myers Squibb's New Drug Application for iberdomide combined with daratumumab and dexamethasone in patients with relapsed or refractory multiple myeloma, with a PDUFA date of August 17, 2026.
Feb 17, 2026
The FDA has accepted Bristol Myers Squibb's new drug application for iberdomide combined with daratumumab and dexamethasone for relapsed or refractory multiple myeloma, with a target action date of August 17, 2026.
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 15, 2026
Nuvalent provided updates on regulatory milestones for its lead oncology programs, including FDA acceptance of the zidesamtinib NDA with a September PDUFA date and plans to submit an NVL-655 NDA in the first half of 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.