Precision Medicine in Oncology®

The FDA has approved encorafenib (Braftovi) plus binimetinib (Mektovi) for adult patients with metastatic non–small cell lung cancer harboring a BRAF V600E mutation, as detected by an FDA-approved test.

The FDA has approved FoundationOne CDx for use as a companion diagnostic for selpercatinib, which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors harboring a RET gene fusion whose disease has progressed on or following prior systemic treatment, or who have no satisfactory alternative treatment options.

The FDA has granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test designed to detect genetic variants associated with an elevated risk of developing certain types of cancer.

Treatment with the first-in-class menin inhibitor revumenib generated complete remissions or complete remissions with partial hematological recovery in adult and pediatric patients with relapsed/refractory acute myeloid leukemia or acute lymphoblastic leukemia harboring KMT2A rearrangements.

Jeremy C. Jones, MD, discusses the applications of circulating tumor DNA testing in colorectal cancer.

Treatment with the combination of sotorasib carboplatin, and pemetrexed produced responses and demonstrated safety in patients with KRAS G12C–mutated, advanced non–small cell lung cancer, according to data from the phase 1/2 CodeBreaK 101 trial.

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.

The phase 3 ENHANCE-2 trial examining the frontline combination of magrolimab and azacitidine vs physician’s choice of venetoclax with azacitidine or intensive chemotherapy in patients with acute myeloid leukemia and TP53 mutations has been discontinued, according to an announcement from Gilead Sciences.

The FDA has granted fast track designation to ABM-1310 for the treatment of patients with glioblastoma harboring BRAF V600E mutations.

The Committee for Medicinal Products for Human Use has recommended the approval of quizartinib in the European Union for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation chemotherapy, followed by maintenance quizartinib, for adult patients with newly diagnosed, FLT3-ITD–positive acute myeloid leukemia.

Marina Sharifi, MD, PhD, discusses the benefit of utilizing personalized and targeted therapy approaches in the treatment of patients with breast cancer.

John Seymour, MBBS, FRACP, PhD, discusses the importance of targeted therapy in patients with chronic lymphocytic leukemia.

The integration of novel mRNA biomarkers into the ColoAlert® screening test resulted in high sensitivity and specificity for colorectal cancer.

In this third episode of OncChats: Leveraging Endoscopic Ultrasound in Pancreatic Cancer, Toufic A. Kachaamy, MD, Madappa Kundranda, MD, PhD, and Tamas A. Gonda, MD, share how they would best utilize genetic testing results obtained from endoscopic ultrasound–guided biopsies in pancreatic ductal adenocarcinomas.

Bryan Schneider, MD, discusses agents available for use in the targeting of MET exon 14 mutations in non–small cell lung cancer.

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 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.

Lyudmila A. Bazhenova, MD, discusses how to treat patients with non–small cell lung cancer who present with EGFR mutations, highlights how to accurately pinpoint gaps in lung cancer care, and expands on how to address these gaps in patients with non–small cell lung cancer.

Natalie Vokes, MD, discusses emerging biomarkers in non–small cell lung cancer, specifically highlighting the promise of HER3-targeted therapy.

In this second episode of OncChats: Leveraging Endoscopic Ultrasound in Pancreatic Cancer, Toufic A. Kachaamy, MD, Madappa Kundranda, MD, PhD, and Tamas A. Gonda, MD, discuss the techniques used such as endoscopic ultrasound–guided biopsies to collect adequate tissue to perform genomic analyses in pancreatic cancer, and the likelihood for finding actionable mutations in this population.

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.

Sanjay Goel, MD, MS, discusses the safety profile of the TKI tinengotinib as a monotherapy and in combination with chemotherapy in patients with solid tumors.

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.

Sanjay Goel, MD, MS, discusses the mechanism of action of tinengotinib and the efficacy of this agent in patients with cholangiocarcinoma.

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.