HUTCHMED’s fanregratinib wins priority review in China for intrahepatic cholangiocarcinoma

HUTCHMED’s fanregratinib wins priority review in China for intrahepatic cholangiocarcinoma

HUTCHMED (China) Limited announced on December 29, 2025, that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for fanregratinib (HMPL-453) with priority review for second-line treatment of adult patients with intrahepatic cholangiocarcinoma harboring FGFR2 fusion or rearrangement. The NDA submission is based on a Phase II registration study in China […]

Is BRCA the new EGFR? Why germline mutations are reshaping prostate cancer treatment strategies

Is BRCA the new EGFR? Why germline mutations are reshaping prostate cancer treatment strategies

The recent FDA approval of Rubraca (rucaparib) for pre-chemotherapy use in BRCA-mutated metastatic castration-resistant prostate cancer marks a strategic inflection for the field. This expanded indication, driven by head-to-head superiority over docetaxel in the TRITON3 Phase 3 trial, positions BRCA mutations as the first molecular biomarker in prostate cancer to carry actionable, label-defining weight in […]

What the TRACERx study reveals about Personalis’ MRD technology in NSCLC

What the TRACERx study reveals about Personalis’ MRD technology in NSCLC

Personalis, Inc. has reported pivotal findings from its NeXT Personal assay in a new Cell publication, highlighting the test’s ability to detect molecular residual disease in stage I to III non-small cell lung cancer. The study, part of the TRACERx initiative and led by Professor Charles Swanton of the Francis Crick Institute and University College […]

How Indivumed’s biospecimen strategy is powering functional tumor model development

How Indivumed’s biospecimen strategy is powering functional tumor model development

Indivumed GmbH and the Wilmot Cancer Institute at the University of Rochester Medical Center have expanded their collaboration to accelerate the development of patient-derived tumor models and AI-informed therapeutic discovery for solid tumors with high unmet clinical need. What this collaboration changes for the cancer model ecosystem The expansion of the Indivumed and University of […]