OncLive Staff

The MHLW approval covers all lines of therapy, including first-line use, in unresectable advanced or recurrent HER2-mutant NSCLC.

The FDA set a target action date of February 2027 for the dostarlimab-gxly sBLA in dMMR/MSI-H locally advanced rectal cancer.

The European Commission approved sacituzumab govitecan plus pembrolizumab for treatment-naive, PD-L1–positive, metastatic triple-negative breast cancer.

Teclistamab-based induction generated a 91.8% MRD-negative complete response rate with a manageable safety profile in multiple myeloma.

The top 5 OncLive TV videos of the week cover insights in ovarian cancer, breast cancer, head and neck cancer, pancreatic cancer, and follicular lymphoma.

UroGen submitted an NDA for UGN-103 in recurrent NMIBC, T-DXd improved PFS in first-line HER2-mutant lung cancer, and more.

In a phase 1/2 study, the LSD1 inhibitor bomedemstat reduced spleen volume, improved symptoms, and lowered driver mutation burden in patients with advanced myelofibrosis.

The NMPA accepted the NDA for the PD-L1/4-1BB–directed bispecific antibody opamtistomig in previously treated advanced extrapulmonary NEC.

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The European Commission approved teclistamab plus daratumumab for relapsed/refractory multiple myeloma after at least 1 prior therapy, offering the regimen as early as second line.

ASCO’s ctDNA guidelines support testing for genetic alterations in select scenarios but do not endorse it for residual disease or recurrence monitoring.

Updated ASCO Living Guideline recommendations expand frontline therapy for HER2-positive gastroesophageal cancer to include zanidatamab-based regimens.

Long-term follow-up showed pTVG-HP nearly doubled median OS compared with placebo in biochemically recurrent prostate cancer.

The FDA has granted fast track designation for safusidenib in IDH1-mutant glioma, with a phase 3 trial on the way.

The FDA has granted 68Ga-NYM096 breakthrough therapy and fast track designations for imaging ccRCC.

The phase 2 ZZFIRST trial met its primary PSA response end point with enzalutamide plus talazoparib in high-volume mHSPC, though the triplet showed added toxicity.

PLN-101095 earned an FDA fast track designation in combination with pembrolizumab for solid tumors resistant to immune checkpoint inhibitors.

Following the RASolute 302 readout, ESMO now endorses daraxonrasib after chemotherapy progression in RAS-mutated metastatic pancreatic cancer.

Harold P. Freeman, MD, pioneer of patient navigation and cancer disparities research, has died at 93. He spent decades bridging gaps in cancer care access.

Intismeran autogene plus pembrolizumab improved recurrence-free survival and distant metastasis–free survival in resected stage IIB to IV melanoma.

The oral OMNI-EGFR inhibitor earned fast track status for advanced EGFR C797S–positive non–small cell lung cancer that progressed on a third-generation EGFR TKI.

The oral PARG inhibitor ETX-19477 earned fast track status for BRCA-mutated, HR-positive, HER2-negative unresectable or metastatic breast cancer.

Weekly oral dordaviprone maintenance after allogeneic transplant produced no DLTs and low rates of grade 3/4 cytopenias in high-risk AML and MDS.

An analysis of 12 randomized trials validated MRD-negative CR as a surrogate for PFS in earlier-line relapsed/refractory multiple myeloma.

Sapanisertib and serabelisib plus paclitaxel received FDA fast track designation for pretreated advanced PI3K/AKT/mTOR pathway–altered endometrial cancer.

Topline phase 3 SAFFRON data showed osimertinib plus savolitinib significantly improved PFS and OS vs chemotherapy in MET-driven, osimertinib-resistant EGFR-mutated NSCLC.

T-DXd improved PFS in the phase 3 DESTINY-Lung04 trial for first-line HER2-mutant NSCLC.

UGN-103, a next-generation mitomycin formulation built on the ZUSDURI foundation, is supported by three-month CR and six-month DOR data from the phase 3 UTOPIA trial.

The phase 3 eVOLVE-Lung02 trial is being discontinued after its IDMC found volrustomig plus chemotherapy unlikely to meet its dual primary end points.

No efficacy benefit was found in adding SBRT to dual checkpoint blockade, though a subset of patients responded to nivolumab plus ipilimumab.