OncLive Staff

The zanidatamab-plus-chemotherapy arm met its overall survival end point at the second interim analysis of the phase 3 HERIZON-GEA-01 trial.

The combination met its primary end point in the phase 3 SANOVO trial, though full efficacy and safety data have not yet been reported.

The supplemental new drug application was submitted under the accelerated approval pathway with a request for priority review.

The top 5 OncLive TV videos of the week cover pancreatic cancer, gastric cancer, GIST, renal cell carcinoma, and chronic lymphocytic leukemia.

The FDA approved daraxonrasib for pancreatic cancer, cleared zanidatamab-based regimens for HER2-positive gastric cancer, and more.

Patient-reported QOL and symptom outcomes were similar between belzutifan plus lenvatinib and cabozantinib in previously treated RCC.

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The conditional approval of fanregratinib is supported by pivotal phase 2 data showing a 42.5% objective response rate in pretreated FGFR2-altered intrahepatic cholangiocarcinoma.

The FDA has granted fast track designation to varsetatug masetecan for relapsed/refractory metastatic colorectal cancer.

SYS6090, a first-in-class PD-1/IL-15 bispecific fusion protein, earned fast track status for MSS/pMMR metastatic colorectal cancer that has progressed on standard systemic therapy.

ASCO issued an alert regarding dwindling supplies of ifosfamide, which is used across testicular cancer and sarcoma regimens.

The FDA approval of daraxonrasib was based on data from the phase 3 RASolute 302 trial in previously treated metastatic pancreatic ductal adenocarcinoma.

SOT106 earned an FDA fast track designation for advanced or recurrent soft tissue sarcoma.

The sNDA is supported by VIKTORIA-1 Study 2 data showing that gedatolisib-based regimens approximately doubled median PFS vs alpelisib plus fulvestrant.

Ivonescimab plus chemotherapy significantly improved overall survival vs durvalumab plus chemotherapy in advanced biliary tract cancer.

The pertuzumab biosimilar TQB2440 met equivalence margins for tpCR vs reference pertuzumab in ER/PR-negative, HER2-positive early breast cancer.

An OncLive Scientific Interchange and Workshop examined community integration of bispecific antibodies in multiple myeloma.

The FDA has approved zanidatamab plus chemotherapy with/without tislelizumab in frontline HER2-positive GEA based on data from HERIZON-GEA-01.

Subcutaneous amivantamab produced a 42% objective response rate and a 15% complete response rate in patients with recurrent/metastatic HNSCC.

The oral pan-RAS molecular glue ERAS-0015 has received FDA fast track designation for the management of metastatic pancreatic adenocarcinoma.

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.