Precision Medicine in Oncology®

The FDA has approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test.

Benjamin P. Levy, MD; Bhuvana Ramkumar, MD; and Neil Morganstein, MD, discuss the challenges with tissue testing facing care teams, as well as multilevel hurdles in procurement, analysis of results, and insurance.

Daniel J. George, MD, discusses the clinical implications use of key trials in metastatic castration-resistant prostate cancer.

Molecular and immune landscapes for solid tumors are constantly evolving as precision medicine techniques become more sensitive and next-generation sequencing methods are taken up in clinical practice.

The FDA has granted an orphan drug designation to vebreltinib for the treatment of patients with non–small cell lung cancer harboring MET genomic tumor aberrations.

The FDA has approved the VENTANA FOLR1 RxDx assay, the first immunohistochemistry companion diagnostic test to help identify patients with epithelial ovarian cancer who are eligible for treatment with mirvetuximab soravtansine-gynx.

All patients with prostate cancer, except for those with low-risk or very low-risk localized disease, should be tested for germline mutations, and somatic testing should be done in all patients with metastatic disease as there are therapeutic implications.

As the role of genetic testing in clinical practice becomes more prevalent for patients with prostate cancer to identify mutations, physicians must consider a variety of factors to determine which patients are candidates for somatic and/or germline testing.

Neal Shore, MD, FACS, highlights the effect of genetic testing on the treatment paradigm of prostate cancer and the evolving treatment landscape for metastatic castration resistant prostate cancer.

A personalized neoantigen-specific and off-the-shelf T cell receptor T-cell therapy utilized through CRISPR gene editing technology demonstrated feasibility and tolerability in 16 patients across multiple tumor types, according to first-in-human phase 1a findings.

Milademetan monotherapy demonstrated preliminary antitumor activity in patients with MDM2-amplified and p53 wild-type advanced solid tumors.

Immunotherapy followed by targeted therapy has emerged as the new standard of care for patients with melanoma with BRAF V600 mutations.

Paul A. DiSilvestro, MD, discusses the long-term survival benefit of olaparib maintenance in advanced BRCA-mutated ovarian cancer.

Andrew McKenzie, PhD, discusses the variety of molecular testing modalities in patients with metastatic non–small cell lung cancer.

Stacey A. Cohen, MD, discusses the results of real-world analysis of patients with resected stage I-III colorectal cancer, how circulating tumor DNA status correlated with recurrence rates, and how these real-world data compared with previous observational studies.

Recent developments in cancers of the thymus, a small organ located in the mediastinum above the heart, have shined a light on a malignancy that only affects about 400 Americans annually.

The accelerated approval of the FGFR inhibitor futibatinib on September 30, 2022, has expanded options for previously treated adult patients with unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma FGFR2 fusions or rearrangements.1

Jeff Yorio, MD, discusses adverse effects associated with targeted agents and combinations in BRAF-mutated melanoma.

Sheena Bhalla, MD, discusses the need for improved understanding of EGFR exon 20 insertion mutations in the development of non–small cell lung cancer treatment.

Jeff Yorio, MD, discusses treatment combinations in BRAF-mutated melanoma.

Jeff Yorio, MD, discussed the decision-making process for treating patients with BRAF-mutant melanoma, the use of immunotherapy in melanoma, and the management of cutaneous squamous cell carcinoma and basal cell carcinoma.

Gilteritinib, in combination with induction and consolidation chemotherapy, generated responses in patients with newly diagnosed acute myeloid leukemia, including those with FLT3 mutations, according to data from a phase 1 trial.

John Lindsay Marshall, MD, discusses past, present, and future developments in molecular testing, as well as the unique offerings of tissue and blood tests and the ways in which these precise approaches will ultimately make cancer diagnosis and treatment more efficient and effective.

Single-agent neratinib produced robust responses in patients with metastatic or recurrent HER2-mutated cervical cancer, according to updated data from phase 2 SUMMIT basket trial.

The FDA has granted a fast track designation to sapanisertib as a potential therapeutic option in patients with unresected or metastatic squamous non–small cell lung cancer whose tumors harbor an NRF2 mutation and who have previously received platinum-based chemotherapy and immune checkpoint inhibition.

The FDA has approved use of the PATHWAY anti-HER2/neu rabbit monoclonal primary antibody as a companion diagnostic to identify patients with HER2-low metastatic breast cancer who are eligible for treatment with trastuzumab deruxtecan.

The FDA has granted an accelerated approval to futibatinib (Lytgobi) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or other rearrangements.

The FDA has approved the Oncomine Dx Target Test as a companion diagnostic to select patients with RET fusion–positive locally advanced or metastatic non–small cell lung cancer, advanced or metastatic thyroid cancer, and advanced or metastatic medullary thyroid cancer who could be candidates to receive selpercatinib.

TAC01-HER2 demonstrated early signals of clinical activity with a tolerable safety profile in patients with HER2-overexpressed solid tumors.