Overview of the CheckMate 8HW Study

Adding zabilugene almadenorepvec to standard gemcitabine/nab-paclitaxel extends survival and response in newly diagnosed metastatic pancreatic cancer, with manageable safety signals.

Late 2026 FDA oncology rulings may reshape care—from CSF-1R and ALK drugs to oral SERDs and BCMA CAR T breakthroughs.

Resubmitted FDA filing advances off-the-shelf EBV-specific T-cell therapy tab-cel for relapsed EBV+ PTLD after transplant, with longer follow-up.

Resection with cesium-131 tile-based radiation therapy prolonged time to surgical bed recurrence vs resection with stereotactic radiation in the phase 3 ROADS trial.

Degevma was approved for skeletal-related events in adults with bone metastases, giant cell tumor of bone, and the treatment of hypercalcemia of malignancy.

FDA fast-tracks plinabulin plus docetaxel for post-immunotherapy non-squamous NSCLC, as DUBLIN-4 phase 3 targets survival gains.

September brought accelerated approvals in ESR1-mutant breast cancer and HER2-mutant non–small cell lung cancer, a Galleri panel vote, and a withdrawn I-DXd application.

The application is supported by the phase 3 SAFFRON trial, in which savolitinib plus osimertinib improved progression-free and overall survival vs chemotherapy.