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Jul 10, 2026
FDA approved subcutaneous isatuximab-irfc for multiple myeloma. Phase 3 EMN24 trial showed 77% MRD negativity with Isa-KRd quadruplet therapy. Phase 2 study showed 77% hematologic response rate in relapsed/refractory AL amyloidosis.
Jun 15, 2026
The U.S. FDA has accepted for filing a New Drug Application for tirabrutinib under the accelerated approval pathway for relapsed or refractory primary central nervous system lymphoma, setting a PDUFA action date of December 18, 2026. The submission is supported by Phase 2 PROSPECT study results showing a 67% overall response rate and 44% complete response rate. If approved, tirabrutinib would be the first BTK inhibitor commercially available in the U.S. for this indication.
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.
Jun 04, 2026
Two studies report on thoracic radiotherapy for lung cancer: a phase III trial found adding radiotherapy to chemoimmunotherapy did not improve survival in extensive-stage small cell lung cancer, while a retrospective review showed high local control rates with single-fraction 28 Gy stereotactic body radiotherapy.
Jun 02, 2026
The FDA has accepted an NDA for iberdomide in combination with anti-CD38 antibodies for relapsed or refractory multiple myeloma. A phase 2 study reports a 39% near complete response rate for the DaraKPd quadruplet therapy with durable MRD negativity. Preclinical research shows the RXR agonist IRX4204 sensitizes myeloma cells to ferroptosis and enhances lenalidomide efficacy.
Jun 01, 2026
The FDA has accepted for review a New Drug Application for tirabrutinib, a Bruton tyrosine kinase inhibitor, for relapsed or refractory primary central nervous system lymphoma. The application is based on phase 2 PROSPECT trial data showing an overall response rate of 67% and complete response rate of 44%. The target action date is December 18, 2026.
May 30, 2026
The phase III frontMIND trial showed that adding tafasitamab and lenalidomide to R-CHOP chemotherapy reduced the risk of progression by 25% in patients with high-risk B-cell lymphomas. The 3-year progression-free survival was 67.3% with the combination versus 60.7% with R-CHOP alone. A dual-targeted CD19/CD20 immunotherapy regimen has also been approved in Australia for relapsed follicular lymphoma.
May 27, 2026
Three trials show ultra-low-dose checkpoint inhibitors retain efficacy with reduced toxicity and dramatically lower costs. DELII and Patil et al. trials tested low-dose nivolumab in solid tumors and HNSCC; NIVIPIT tested intratumoral low-dose ipilimumab in melanoma.
May 19, 2026
An interim phase 3 analysis showed mezigdomide plus carfilzomib and dexamethasone reduced the risk of progression or death in relapsed/refractory multiple myeloma. The SUCCESSOR-2 study remains ongoing and will assess overall survival and safety.
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 07, 2026
Sensei Biotherapeutics dosed the first patient in a Phase 1b/2 trial of PIKTOR (sapanisertib + serabelisib) in HR+/HER2- advanced breast cancer. The multi-node PI3K/AKT/mTOR inhibitor previously showed a 47% overall response rate in a Phase 1b trial.
May 07, 2026
Slow up-dosing peanut OIT enabled 82% of toddlers to tolerate 3.5 peanuts after treatment. Low-dose OIT was safe in preschoolers with single or multiple food allergies. Allergist guidance on anxiety was linked to reduced caregiver worry.
May 05, 2026
FDA approval of daratumumab for high-risk smoldering multiple myeloma marks a shift from observation to early intervention. In a Phase II trial in earlier-stage disease, the overall response rate was 54% and the primary endpoint was not met.
May 04, 2026
Cynata raised $1.5 million through a placement at $0.25 a share ahead of Phase 3 osteoarthritis and Phase 2 aGvHD trial readouts due in May and June 2026. Its aGvHD study has completed the 100-day primary evaluation period for all 65 participants.
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 01, 2026
Crescent Biopharma dosed the first patient in its ASCEND Phase 1/2 trial of CR-001, a PD-1 x VEGF bispecific antibody for solid tumors. The company also reported Q1 2026 results and outlined pipeline milestones including ADC combination trials expected in the second half of 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 26, 2026
Zocilurtatug pelitecan showed an overall response rate of 38.2% and a disease control rate of 55.9% in 34 patients with pretreated extrapulmonary neuroendocrine carcinomas. Grade 3 or higher treatment-emergent adverse effects occurred in 30.4% of patients.
Apr 23, 2026
Incyte has started the phase 3 Dawn-03 trial of INCB161734 plus chemotherapy in first-line KRAS G12D-mutant pancreatic cancer. The move comes while the phase 1 study remains halted in four European countries after pneumonitis cases, including one grade 5 event.
