FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
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.
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.
The FDA approved oral decitabine and cedazuridine tablets plus venetoclax for newly diagnosed AML in patients 75 and older or those ineligible for intensive induction chemotherapy. The approval was supported by phase 1/2 ASTX727-07 data showing a 41.6% complete response rate.
Tumour-infiltrating lymphocyte therapy has shown durable responses in refractory melanoma, including a 31.4% objective response rate in phase II data. The 2024 FDA approval of Lifileucel marked a milestone as regulators in other markets continue reviews.
The FDA has accepted for review a supplemental application for taletrectinib in advanced ROS1-positive NSCLC, with a PDUFA date of January 4, 2027. Updated TRUST-I and TRUST-2 data showed high response rates, durable responses and no new safety signals.
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.
Phase III data showed dirozalkib improved progression-free survival and intracranial efficacy versus crizotinib in first-line ALK-positive advanced NSCLC. The drug received NMPA approval in August 2025.
Tango Therapeutics said it plans to start a pivotal 300-patient randomized vopimetostat trial in second-line pancreatic cancer this year after FDA interactions. The company also reported early combination enrollment with daraxonrasib and zoldonrasib and said more monotherapy and combination data are expected later this year.
Early results from stage I of the phase 3 PRESERVE-003 trial showed gotistobart improved overall survival versus docetaxel in previously treated metastatic squamous NSCLC. Objective response rate and duration of response also favored gotistobart, while progression-free survival did not differ significantly.
