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.

Scott Kopetz, MD, PhD, FACP, discusses the safety of encorafenib plus cetuximab with/without chemotherapy in BRAF V600E–mutant metastatic colorectal cancer.

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.

Katherine L. Nathanson, MD, discusses the impact of reversion mutations on resistance to PARP inhibitors across various DNA damage repair genes.

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.

Ignacio Garrido-Laguna, MD, PhD, MBA, discusses the safety profile of daraxonrasib in patients with KRAS-mutated pancreatic ductal adenocarcinoma

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.

Aditya Bardia, MD, MPH, FASCO, discusses the need for widespread HER2 testing in patients with HER2-low and -ultralow metastatic breast cancer.

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.

Jin-Ji Yang, MD, discusses osimertinib plus savolitinib as a first-line treatment in patients with de novo MET-aberrant, EGFR-mutant advanced NSCLC.

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