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Aug 20, 2026
The FDA granted breakthrough therapy designation to subcutaneous amivantamab for recurrent or metastatic HPV-unrelated HNSCC after progression on platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The decision was supported by OrigAMI-4 cohort 1 data showing a 45% ORR and 76% clinical benefit rate.
May 15, 2026
The FDA's January draft guidance proposes MRD-negative complete response as an accelerated approval end point for multiple myeloma drugs. It defines MRD negativity, sets trial design requirements, and accepts comments through March 23, 2026. Expert Nicholas Richardson discusses calibration challenges and the single-trial model.
Jul 24, 2026
A phase 3 trial of azacitidine and chidamide plus CHOP in untreated PTCL showed a significant overall survival improvement but no significant gains in response rate or progression-free survival. The study suggests molecular profiling could guide future therapies.
Jul 20, 2026
Kura Oncology's ziftomenib shows 96% complete response in frontline AML and $5.8M in early commercial sales; updated FIT-001 trial data for kidney cancer to be presented at 2026 summit; analysts see significant upside with an average target of $32.45.
Jun 10, 2026
Two separate clinical trials have reported advances in cancer care. An oral drug combination of decitabine-cedazuridine and venetoclax showed efficacy in older patients with acute myeloid leukemia, with a 47% complete response rate in a phase 2b trial. A separate randomized controlled trial found that delaying pegfilgrastim administration to 72 hours post-chemotherapy significantly reduced bone pain in women with stage I–III breast cancer.
Jun 09, 2026
Updated data from the phase I CaMMouflage trial showed CB-011, the first allogeneic anti-BCMA CAR-T therapy with immune cloaking, achieved an approximately 92% overall response rate in relapsed/refractory multiple myeloma. The 2026 Tandem Meetings also highlighted advances in EB-103, KITE-753, and LV20.19 CAR-T constructs across lymphoma and CLL. Separately, NXC-201 reported a 95% complete response rate in AL amyloidosis.
Jun 05, 2026
Real-world studies show early complete response after CAR T-cell therapy predicts sustained remission in large B-cell lymphoma, while historical chemotherapy yields poor outcomes in high-risk patients. Data from registries highlight a significant event-free survival advantage for second-line axicabtagene ciloleucel versus standard-of-care salvage therapy.
May 22, 2026
A phase II trial of TAK-007 CAR-NK therapy in R/R B-cell NHL showed a 60.9% overall response rate. Preclinical CAR-NKT therapy eliminated endometrial tumors in models. Optimized costimulatory domains (2B4-DAP12) boosted CAR-NK tumor killing.
May 18, 2026
The FDA approved Bristol Myers Squibb’s Breyanzi for adults with relapsed or refractory marginal zone lymphoma after at least two prior systemic therapies. In TRANSCEND FL, the CAR T therapy showed a 95.5% overall response rate and 62.1% complete response rate.
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 11, 2026
Recent studies demonstrate zanubrutinib delivers higher response rates, longer treatment persistence, and lower healthcare costs compared to acalabrutinib and ibrutinib across multiple B-cell malignancies, with particularly strong benefits in high-risk populations.
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/refractory multiple myeloma in March 2026, and Darzalex Faspro-based quadruplet D-VRd for newly diagnosed transplant-ineligible patients in January 2026.
Mar 04, 2026
The 2026 ASCO GU Symposium featured significant trial results in renal cell carcinoma, urothelial carcinoma, and prostate cancer, including data from LITESPARK-022, KEYNOTE-B15, SunRISE-2, and PEACE-3 studies.
Feb 27, 2026
ImmunityBio completed enrollment of 366 patients in its Phase 2 trial of ANKTIVA plus BCG versus BCG alone for BCG-naïve bladder cancer. Interim analysis showed statistically significant improvement in duration of complete response, with the company anticipating a BLA submission by Q4 2026.
Feb 24, 2026
AIM ImmunoTech outlined key milestones for its Phase 2 DURIPANC trial evaluating Ampligen combined with durvalumab in metastatic pancreatic cancer, with primary endpoint evaluation expected in December 2026.
Feb 23, 2026
Two clinical trials demonstrate efficacy of talimogene laherparepvec (T-VEC) oncolytic virus therapy in HER2-negative breast cancer and nonmelanoma skin cancers, with favorable safety profiles and durable responses in subset of patients.
