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.
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
Cellectar reported 12-month follow-up from the Phase 2b CLOVER WaM trial of iopofosine I 131 in relapsed or refractory Waldenström macroglobulinemia. In 55 patients, ORR was 83.6%, MRR was 61.8% and median duration of response was 17.8 months.
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.
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.
Apr 15, 2026
PDS Biotechnology announced positive interim Phase 2 Stage 1 data for PDS01ADC plus HAIP in MSS/pMMR colorectal liver metastases. The trial showed a 77.8% objective response rate and about 85% 24-month survival in 9 patients.
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.
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 11, 2026
The FDA has granted fast track designation to QRX003 for Netherton Syndrome and IBI3003 for relapsed or refractory multiple myeloma, while also accepting regulatory applications for other therapies addressing serious conditions with unmet medical needs.
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 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
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
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 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 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 21, 2026
The FDA has approved a once-monthly dosing schedule for subcutaneous amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) combined with lazertinib for first-line treatment of EGFR-mutated advanced NSCLC, based on PALOMA-2 trial data showing comparable efficacy to biweekly dosing.
Feb 20, 2026
The FDA has accepted a new drug application for giredestrant plus everolimus for ESR1-mutated, ER-positive, HER2-negative advanced breast cancer, with a decision expected by December 18, 2026. The phase 3 evERA study showed a 62% reduction in disease progression or death risk in ESR1-mutated patients.
Feb 17, 2026
Pfizer announced positive progression-free survival results from the BREAKWATER trial evaluating Braftovi in combination with cetuximab and Folfiri in previously untreated metastatic colorectal cancer patients with BRAF V600E mutation.