May 20, 2026
Phase 3 BREAKWATER found encorafenib plus cetuximab plus FOLFIRI improved PFS and response in first-line BRAF V600E-mutant metastatic colorectal cancer. OS data remain immature.
May 13, 2026
ABL111 received FDA agreement on an accelerated approval pathway for metastatic gastric cancer as the first patient was dosed in a global phase 2 trial. The companies said ORR will support accelerated approval and phase 2 is evaluating ABL111 with nivolumab and mFOLFOX6.
May 05, 2026
ORIC selected rinzimetostat 400 mg plus darolutamide for the Himalayas-1 Phase 3 trial in post-abiraterone mCRPC, expected to start in 1H 2026. The company reported early efficacy and safety data and said cash runway extends into 2H 2028.
May 02, 2026
Phase 3 trial data show daratumumab reduced relapse risk by 74% in NMOSD. Separately, the FDA accepted an NDA for iberdomide plus daratumumab/dexamethasone in relapsed/refractory multiple myeloma, with a PDUFA date of August 17, 2026.
May 02, 2026
FDA has accepted the NDA for vepdegestrant (ARV-471), an oral PROTAC ER degrader from Arvinas and Pfizer, for ESR1-mutated ER+/HER2- advanced breast cancer. A PDUFA date of June 5, 2026 has been set. The submission is based on positive Phase 3 VERITAC-2 data.
May 01, 2026
FDA's ODAC voted 6-3 against AstraZeneca's camizestrant for HR+/HER2- metastatic breast cancer, citing uncertain clinical benefit from the SERENA-6 trial design. The FDA raised concerns about the early-switch treatment paradigm and long-term outcomes.
Apr 28, 2026
Compass Therapeutics reported mixed Phase 2/3 data for tovecimig in biliary tract cancer and plans to meet with the FDA for a BLA discussion. The study met its primary ORR endpoint (17% vs 5%), while PFS and OS data are due late this quarter.
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 20, 2026
A study of 366 patients found ide-cel CAR-T cell therapy achieved 81.6% overall response rate in patients 70 or older with relapsed/refractory multiple myeloma, with median progression-free survival of 18.9 months versus 5.7 months with standard regimens.
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 13, 2026
Decreases in circulating tumor DNA within 3-4 weeks of immune checkpoint inhibitor therapy were strongly associated with higher response rates and longer survival in patients with unresectable stage III/IV melanoma, according to a multi-institutional retrospective analysis.
Mar 13, 2026
Real-world data from over 300 large B-cell lymphoma patients treated with axicabtagene ciloleucel show response rates and survival outcomes remarkably similar to pivotal trial results, with 86% overall response rate and 74% one-year survival.
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 11, 2026
IDEAYA Biosciences announced Q4 2025 financial results with $1.05 billion in cash reserves and confirmed 130 progression-free survival events in its Phase 2/3 OptimUM-02 trial of darovasertib for metastatic uveal melanoma, with topline results expected by late March 2026.
Mar 04, 2026
Can-Fite BioPharma's drug candidate namodenoson met its primary endpoint in a Phase 2a pancreatic cancer trial and demonstrated anti-obesity effects in a peer-reviewed preclinical study published in the International Journal of Obesity.
Mar 04, 2026
Citius Pharmaceuticals reported $3.9 million in first revenue from LYMPHIR's December 2025 launch for cutaneous T-cell lymphoma, while subsidiary Citius Oncology announced positive Phase 1 data showing 86% response rate when LYMPHIR was administered prior to CAR-T therapy in high-risk lymphoma patients.
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%.
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.
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 27, 2026
Izalontamab brengitecan demonstrated statistically significant improvements in progression-free survival and overall survival compared to chemotherapy in patients with previously treated metastatic triple-negative breast cancer, marking the third Phase III success for the bispecific ADC.