Articles

  • 1 week ago | targetedonc.com | Jordyn Sava

    The FDA has granted orphan drug designation (ODD) to SENTI-202 for relapsed/refractory (R/R) hematologic malignancies, including acute myeloid leukemia (AML). SENTI-202 is a first-in-class, off-the-shelf, logic-gated CAR NK-cell therapy engineered to selectively target CD33/FLT3+ malignant cells while sparing healthy bone marrow.

  • 1 week ago | targetedonc.com | Jordyn Sava

    HER2-mutant non–small cell lung cancer (NSCLC) presents a significant unmet need in oncology, particularly concerning targeted therapeutic options. While advancements have been made in other oncogenic drivers like EGFR, ALK, and ROS1, the landscape for HER2 mutations has remained comparatively limited. Current treatment paradigms often rely on cytotoxic chemotherapy, with fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) being the only approved agent in the second-line setting.

  • 1 week ago | targetedonc.com | Jordyn Sava

    Tafasitamab-cxix (Monjuvi) is now FDA-approved with lenalidomide (Revlimid) and rituximab (Rituxan) for adults with relapsed/refractory follicular lymphoma (R/R FL). The inMIND trial (NCT04680052) showed a 57% reduction in risk of progression or death, with median progression-free survival (PFS) of 22.4 months vs. 13.9 months in control. Serious infections occurred in 24% of patients; label includes warnings for infusion reactions, myelosuppression, and infection risk.

  • 1 week ago | targetedonc.com | Jordyn Sava

    New data from an ongoing phase 2a trial (NCT05585320) suggest that atebimetinib (IMM-1-104), an oral, once-daily novel MEK inhibitor, in combination with modified gemcitabine/nab-paclitaxel (mGnP), may offer significant survival benefits in the first line for patients with pancreatic cancer.

  • 1 week ago | targetedonc.com | Jordyn Sava

    The FDA has approved an update to the labeling for talazoparib (Talzenna) in combination with enzalutamide (Xtandi) for men with metastatic castration-resistant prostate cancer (mCRPC).1 This regulatory action incorporates the final overall survival (OS) data for the combination within its existing indication for the treatment of adults with homologous recombination repair (HRR) gene-mutated mCRPC.

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