The OncLive Precision Medicine in Oncology® condition center page is a comprehensive resource for clinical news and expert insights on precision-focused approaches in patients with cancer, with gene-targeted tyrosine kinase inhibitors and antibody-drug conjugates, checkpoint inhibitors, tumor-infiltrating lymphocyte therapy, and other tailored treatments. This page features news articles, interviews in written and video format, and podcasts that focus on updates and ongoing research with personalized therapies across solid and hematologic tumors.
September 27th 2023
The FDA has granted fast track designation to IDE161 for use in adult patients with advanced or metastatic hormone receptor–positive, HER2-negative breast cancer harboring BRCA1/2 mutations who have progressed after at least 1 hormonal therapy, a CDK4/6 inhibitor, and a PARP inhibitor.
September 26th 2023
PhaseEd-Seq MRD Detection May Provide Effective Alternative to Standard Imaging in LBCL
Current research suggests that circulating tumor DNA may have prognostic value when conducted at the conclusion of treatment in large B-cell lymphoma, indicating that minimal residual disease detection using ctDNA assessments such as PhaseEd-Seq could address imitations associated with the use of computed tomography or positron emission tomography/CT scans at this stage.
Early Cytogenetic or Molecular Landmark Response to Ponatinib Predicts Outcomes in CP-CML
Early cytogenetic and molecular responses achieved with ponatinib was significantly linked with better long-term progression-free survival and overall survival in patients with highly resistant, pretreated chronic-phase chronic myeloid leukemia.
Divarasib Displays Early-Phase Activity in KRAS G12C–Mutant Solid Tumors
Treatment with the KRAS G12C inhibitor divarasib (formerly GDC-6036) led to durable responses with a tolerable safety profile in patients with a variety of solid tumors harboring a KRAS G12C mutation.
Encorafenib/Binimetinib Combo Highlights Novel Therapies for BRAF V600+ NSCLC
Corey J. Langer, MD, outlines the prevalence of BRAF mutations in NSCLC and looked ahead to where the development pipeline of agents for the treatment of patients with BRAF-mutated NSCLC is headed.
Repotrectinib Gets Breakthrough Therapy Designation in China for NTRK+ TKI-Pretreated Solid Tumors
The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted breakthrough therapy designation to repotrectinib for use in patients with advanced solid tumors harboring a NTRK gene fusion who experienced disease progression after TKI treatment.
Savolitinib Wins Breakthrough Therapy Designation in China for Gastric Cancer With MET Amplification
The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted a breakthrough therapy designation to savolitinib for use in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction with MET amplification in whom at least 2 lines of standard therapy have failed.
FDA Grants Fast Track Status to ALE.C04 for Recurrent or Metastatic CLDN1+ HNSCC
The FDA has granted fast track designation to ALE.C04 for use as a potential therapeutic option in patients with recurrent or metastatic, Claudin-1–positive head and neck squamous cell carcinomas.
Erdafitinib Elicits Responses in FGFR-altered Solid Tumors
Treatment with erdafitinib resulted in clinical benefit for patients with advanced solid tumors harboring susceptible FGFR alterations who had exhausted all other treatment options, meeting the primary end point of overall response rate of the phase 2 RAGNAR trial.
Trastuzumab Deruxtecan Approved in Japan for HER2-Mutated Metastatic NSCLC
Japan’s Ministry of Health, Labour, and Welfare has approved fam-trastuzumab deruxtecan-nxki for use in adult patients with unresectable advanced or recurrent, HER2-mutant non–small cell lung cancer that has progressed following chemotherapy.
Selpercatinib Significantly Improves PFS Over MKIs in RET-Mutant Medullary Thyroid Cancer
Selpercatinib demonstrated a statistically significant improvement in progression-free survival vs physician’s choice of cabozantinib or vandetanib in patients with advanced or metastatic RET-mutant medullary thyroid cancer, meeting the primary end point of the phase 3 LIBRETTO-531 trial.
Dr Ravi on the Use of Lutetium Lu 177 Vipivotide Tetraxetan in mCRPC
August 18th 2023Praful K. Ravi, MB, BChir, MRCP, discusses the use of prostate-specific membrane antigen-targeted therapies in metastatic castration-resistant prostate cancer, highlighting the use of the targeted radioligand lutetium Lu 177 vipivotide tetraxetan.
Zeynep Eroglu, MD, explains the rationale for adding navitoclax to dabrafenib plus trametinib in the treatment of patients with BRAF V600–mutant metastatic melanoma, highlights the methodologies and results of the CTEP-P9466 trial, and describes the implications of this research for this patient population.
FDA Grants Priority Review to Ivosidenib for IDH1+ Relapsed/Refractory MDS
The FDA has granted priority review to the supplemental new drug application seeking the approval of ivosidenib for the treatment of patients with IDH1-mutated, relapsed/refractory myelodysplastic syndrome.
FDA Approves Companion Diagnostic for Niraparib Plus Abiraterone Acetate in BRCA+ mCRPC
The FDA has approved FoundationOne CDx to be utilized as a companion diagnostic for the dual-action tablet of niraparib plus abiraterone acetate, which was approved for use in combination with prednisone in adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.
BDC-1001 Monotherapy Under Further Evaluation in Phase 2 Trial in HER2+ Cancers
The first patients have been dosed in the phase 2 portion of a phase 1/2 trial evaluating BDC-1001 monotherapy in patients with HER2-positive colorectal cancer, endometrial cancer, and gastroesophageal cancer.
China’s Center for Drug Evaluation of the National Medical Products Administration has granted a breakthrough therapy designation to glecirasib for the treatment of patients with pancreatic cancer harboring a KRAS G12C mutation and who have progressed after frontline standard-of-care treatment.
Dr Danish on the Potential for Treatment with SCINTIX Radiation Technology in Lung and Bone Cancers
August 8th 2023Adnan F. Danish, MD, discusses the potential for SCINTIX radiation technology to open new treatment opportunities for patients with cancer, including those with lung and bone cancers, whose disease has metastasized to more than 5 sites.
FDA Green Lights Companion Diagnostic for Avapritinib in Gastrointestinal Stromal Tumors
The FDA has approved the therascreen PDGFRA RGQ PCR kit for use as a companion diagnostic, co-developed by Qiagen and Blueprint Medicines, to assist in the identification of patients with gastrointestinal stromal tumors who may be candidates to receive avapritinib.
Dr Danish on the Potential Use of SCINTIX Radiation Technology in Bone and Lung Tumors
August 2nd 2023Adnan F. Danish, MD, discusses the methodologies behind the use of SCINTIX radiation technology in metastatic bone and lung tumors, detailing how this technology differs from computed tomography or magnetic resonance imaging scans prior to treatment.
FDA Approves Companion Diagnostic for Quizartinib in FLT3-ITD+ AML
The FDA has approved the LeukoStrat CDx FLT3 Mutation Assay for use as a companion diagnostic to select patients with FLT3-ITD–positive acute myeloid leukemia who may be eligible to receive treatment with quizartinib (Vanflyta).1
Dr Danish on the Challenges of Radiation Treatment in Lung and Bone Cancers
July 17th 2023Adnan F. Danish, MD, discusses unmet needs in the treatment of patients with lung and bone cancers, and how unmet needs within this patient population are being addressed with the utilization of SCINTIX radiation technology.
Novel Radiotherapy Supports Precision Medicine Advances in Lung and Bone Cancers
July 13th 2023Adnan F. Danish, MD, discusses current unmet needs in the treatment of patients with stage IV lung and bone cancers, the benefits SCINTIX technology can provide for these patients, and how John Theurer Cancer Center plans to use this technology to improve patient outcomes and support further radiation therapy research.
Paxalisib Plus Radiation Earns FDA Fast Track Status for PI3K+ Solid Tumor Brain Metastases
The FDA has granted a fast track designation to paxalisib in combination with radiation therapy for the treatment of patients with solid tumor brain metastases harboring PI3K pathway mutations.