
The FDA has granted priority review to a new drug application seeking the approval of tovorafenib monotherapy for the treatment of pediatric patients with relapsed or progressive low-grade glioma.

The FDA has granted priority review to a new drug application seeking the approval of tovorafenib monotherapy for the treatment of pediatric patients with relapsed or progressive low-grade glioma.

Postoperative circulating tumor DNA (ctDNA)–based minimal residual disease status demonstrated prognostic value for patients with stage I to IV resected colorectal cancer, showing that those with positive ctDNA after surgery have significantly lower disease-free survival outcomes at 24 months vs those who were ctDNA negative.

Marisol Miranda-Galvis, DDS, MS, PhD, highlights the importance of understanding which social determinants of health have the greatest influence on treatment-related outcomes in patients with hematologic malignancies, expands on key variables identified in a systematic review of these disparities, and emphasizes the importance of continuing to implement new strategies to increase access to quality treatments.

Richard Kim, MD, discusses the range of systemic treatment options available for patients with unresectable hepatocellular carcinoma and the importance of assessing patients for high-risk disease criteria before beginning any systemic treatment.

The FDA has approved toripalimab-tpzi (Loqtorzi) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma, and as monotherapy for the treatment of adult patients with recurrent, unresectable, or metastatic nasopharyngeal carcinoma with disease progression on or after platinum-containing chemotherapy.

Pooled findings from exploratory analyses of the phase 2 DESTINY-Lung01 and DESTINY-Lung02 trials showed that different doses of fam-trastuzumab deruxtecan-nxki elicited similar intracranial responses in patients with HER2-mutated non–small cell lung cancer who had treated or untreated brain metastases at baseline.

Praveen Vikas, MBBS, discusses what is currently known regarding minimal residual disease testing in breast cancer, expanded on what still needs to be done to bring minimal residual disease and ctDNA testing to clinical practice, and highlighted the evolving treatment paradigm for patients with advanced hormone receptor-positive, HER2-negative breast cancer.

The FDA has granted fast track designation to the dual-acting androgen receptor inhibitor ONCT-534 for the treatment of patients with relapsed/refractory, metastatic castration-resistant prostate cancer that is resistant to approved androgen receptor pathway inhibitors.

The European Medicines Agency has accepted a marketing authorization application seeking the approval of mirvetuximab soravtansine-gynx for the treatment of patients with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Temple Health was recently recognized with the American College of Gastroenterology’s Service Award for Colorectal Cancer Outreach, Prevention & Year-Round Excellence for its coordinated health campaign against colon cancer.

Despite the discovery of protein arginine methyltransferase 5 more than 20 years ago, interest in the potential oncogene as a treatment target for patients with hematologic and solid malignancies has increased in recent years with the advancement of multiple novel agents through preclinical and early-phase studies.

The combination of ibrutinib and bortezomib elicited durable responses in patients with relapsed or refractory mantle cell lymphoma and high-risk features such as a Ki-67 over 30%, blastoid or pleomorphic variant, p53 overexpression, and TP53 mutations and/or deletions.

Datopotamab deruxtecan elicited encouraging responses in patients with heavily pretreated non–small cell lung cancer harboring actionable genomic alterations.

The FDA has accepted the resubmission of a biologics license application seeking the approval of N-803 in combination with Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive, non–muscle-invasive bladder cancer with carcinoma in situ with or without Ta or T1 disease.

Vitaly Margulis, MD, expands on the factors to consider when treating patients with advanced RCC and how these could help inform the selection of immunotherapy-based combinations in the frontline setting.

Ricardo D. Parrondo, MD, highlights the current use of covalent BTK inhibitors in chronic lymphocytic leukemia, potential roles for the non-covalent BTK inhibitor pirtobrutinib, and the importance of future research on time-limited treatment options for patients with newly diagnosed chronic lymphocytic leukemia.

Press Release
Ontada®, a McKesson business dedicated to leveraging oncology real-world data and evidence, clinical education, and provider technology, was awarded a competitive contract with the U.S. Food and Drug Administration to advance the use of real-world data in the U.S. community oncology setting.

While progress in outcomes has been greater in non–small cell lung cancer, recent advances, including molecularly targeted therapies against EGFR and ALK, checkpoint inhibitors that boost immune response, improved staging, and video-assisted surgery have all contributed to progress in treatment of all types of lung cancer, including in SCLC.

Catherine C. Coombs, MD, discusses a real-world investigation of switching to a BCL-2 inhibitor-based regimen vs another covalent BTK inhibitor in patients with chronic lymphocytic leukemia/small lymphocytic leukemia who were intolerant to a prior covalent BTK inhibitor and highlighted factors to consider when deciding between these 2 approaches for this patient population.

ARX517 displayed preliminary efficacy and a strong safety profile in patients with metastatic castration-resistant prostate cancer, according to findings from the phase 1/2 APEX-01 study.

Vepdegestrant continued to showcase clinical activity with favorable tolerability spanning all doses examined in heavily pretreated patients with estrogen receptor–positive, HER2-negative advanced breast cancer, according to updated dose-escalation data from a phase 1/2 study.

Jennifer A. Woyach, MD, elucidates the updated results generated from a phase 2 study of venetoclax monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) whose disease progressed on a prior B-cell receptor inhibitor, expanded on key findings from a genomic analysis from the study, and highlighted what these findings could mean for the CLL treatment paradigm.

Press Release
The National Cancer Institute awarded investigators at Huntsman Cancer Institute a grant totaling more than $3 million to conduct a clinical trial to see if combining creatine monohydrate supplementation and resistance exercise training helps preserve muscle in people who have metastatic prostate cancer.

The FDA has granted an orphan drug designation to TTX101 as a potential therapeutic option for patients with malignant glioma.

The combination of bezuclastinib and sunitinib had a tolerable safety profile and demonstrated early signals of clinical activity in patients with gastrointestinal stromal tumor.

Denise M. Wolf, PhD, discusses the methods used to conduct the I-SPY2 study and the implications that immune biomarkers could have on selecting treatment for patients with hormone receptor–positive, HER2-negative breast cancer in the future.

It is difficult to browse a major medical journal these days and not find an article, commentary, or editorial that discusses the objectively rather profound implications for clinical science and health care delivery resulting from simply stunning advances in computer technology in the arena of artificial intelligence.

The FDA has approved ivosidenib (Tibsovo) for the treatment of adult patients with relapsed/refractory myelodysplastic syndromes with a susceptible IDH1 mutation, as detected by an FDA-approved test.

Tian Zhang, MD, MHS, details how updated data presented at the 2023 ASCO Annual Meeting from trials such as KEYNOTE-426 and CLEAR have showed the sustained efficacy of VEGF plus immunotherapy combinations vs sunitinib in the first-line setting; discusses where the immunotherapy-only combination of ipilimumab and nivolumab fits in the frontline setting; and highlights how data from CONTACT-03 provided key insights on the use of immunotherapy in patients with advanced renal cell carcinoma after progression on a prior immune checkpoint inhibitor.

As a result of the Affordable Care Act’s Medicaid expansion, positive trends are becoming apparent regarding mortality rates for patients with cancer living in the states that have adopted Medicaid expansion.