OncLive Staff

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.

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.