Precision Medicine in Oncology®

The FDA has granted full approval to larotrectinib for select patients with solid tumors harboring a NTRK gene fusion.

Daraxonrasib was safe and active in the pretreated advanced non–small cell lung cancer harboring RAS mutations.

The FDA has received an NDA for ziftomenib in relapsed/refractory NMP1-mutant acute myeloid leukemia.

Savolitinib plus osimertinib produced responses in pretreated MET-amplified or -overexpressed advanced non–small cell lung cancer harboring EGFR mutations.

Tanios S. Bekaii-Saab, MD, details studies of ctDNA-guided strategies that are elucidating the role of adjuvant therapies in CRC and agents of promise.

Here is your Q2 2025 preview spotlighting 7 FDA decisions to watch, including upcoming PDUFAs for nivolumab/ipilimumab, belzutifan, UGN-102, avutometinib/defactinib, and more.

The top 5 OncLive videos of the week cover insights in multiple myeloma, HER2+ breast cancer, non¬–muscle-invasive bladder cancer, and ovarian cancer.

Fulzerasib plus cetuximab elicited deep efficacy in patients with KRAS G12C–mutated NSCLC enrolled in the phase 2 KROCUS study.

Adagrasib plus pembrolizumab continued to show promising efficacy in patients with KRAS G12C–mutated NSCLC and PD-L1 TPS of 50% or higher.

Pediatric patients with TRK fusion–positive sarcomas may be able to safely discontinue larotrectinib and resume treatment if needed without sacrificing response.

The investigational new drug application for the RDC SKB107 for the management of solid tumor bone metastases has been approved in China.

Pembrolizumab combination gets full approval in select HER2+ gastric/GEJ cancer, PSMA PET imaging agent is cleared for prostate cancer, and more from OncLive.

Aditya Shreenivas, MD, MS, discusses the association between Claudin 18 and MUC1 biomarkers and ongoing targeted therapy challenges.

Ajay Goel, PhD, AGAF, discusses the potential utility of CA19-9 with an exosome-based liquid biopsy as a diagnostic biomarker in early-stage pancreatic cancer.

The top 5 OncLive videos of the week cover insights in colorectal cancer, myeloma, HER2+ breast cancer, and KRAS G12X+ pancreatic ductal adenocarcinoma.

Vepdegestrant boosts PFS in select ESR1-mutated breast cancer, maintenance OSE2101 combination provides survival benefit in PDAC, and more from OncLive.

Preclinical cytotoxicity was demonstrated with anti-CD38-CAR-gamma-delta T cells in multiple myeloma.

MT-8421, a novel engineered toxin body targeting CTLA-4, was not associated with grade 4 or 5 toxicities in patients with select advanced solid tumors.

The feasibility and safety of treatment with SAR443216 support the further investigation of this agent in patients with advanced HER2-positive tumors.

Frontline treatment with datopotamab deruxtecan plus durvalumab with/without carboplatin proved active in advanced NSCLC without actionable alterations.

Zongertinib showed responses across HER2-mutated tumor types, including in lung cancer, with a tolerable safety profile.

The top 5 OncLive videos of the week cover insights in TGCT, NSCLC, TNBC, AML, and MDS.

Alberto Chiappori, MD, details how to select between ensartinib and approved ALK TKIs for NSCLC, as well as considerations with ensartinib’s FDA approval.

NOMA has approved the PET imaging agent for the identification of PSMA-positive lesions in patients with prostate cancer.

Treatment with ivosidenib plus CPX-351 showed early efficacy in patients with relapsed/refractory AML or high-risk MDS harboring an IDH1 mutation.

Maurie Markman, MD, discusses the differences between prognostic vs predictive factors and their clinical utility in oncology practice.

The top 5 videos of the week cover insights in ovarian cancer, NSCLC, CSCC, follicular lymphoma, and CLL.

Incorporation of menin inhibitors is central to improving the outcome of difficult-to-treat leukemias.

FDA grants priority review to zongertinib in HER2-mutant NSCLC and dordaviprone for recurrent H3K27M+ diffuse glioma, and more from OncLive this week.

The FDA has granted priority review to zongertinib for unresectable or metastatic HER2-mutant advanced NSCLC.