
The FDA has accepted for review a biologics license application for a proposed denosumab biosimilar, according to an announcement from Sandoz, Inc.

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The FDA has accepted for review a biologics license application for a proposed denosumab biosimilar, according to an announcement from Sandoz, Inc.

Although the incidence, location, and histology of esophageal cancer vary globally, patients in the Western World typically develop esophageal cancer in the distal esophagus or at the gastroesophageal junction.

Natalie S. Callander, MD, contextualizes the implications of the phase 3 ATLAS trial findings alongside other trials investigating maintenance regimens with triplet therapies in multiple myeloma.

Rachna T. Shroff, MD, MS, expands on the rationale for evaluating the addition of nab-paclitaxel to gemcitabine/cisplatin in patients with newly diagnosed biliary tract cancers, data presented from SWOG 1815, and how this study may pave the way for future research efforts in the paradigm.

The World Health Organization has released new framework guidelines with the goal of saving 2.5 million lives from breast cancer by 2040 through a combination of early detection, timely diagnosis, and comprehensive management.

Andrzej Jakubowiak, MD, PhD, highlighted several key studies that influenced the development and design of the ATLAS trial, introduced conclusions from the initial efficacy data, and discussed how ongoing analysis could further contextualize and inform post-transplant treatment approaches in multiple myeloma.

Revumenib resulted in deep response rates, facilitating subsequent transplant in patients with KMT2A-rearranged or NMP1-mutant, relapsed/refractory acute myeloid leukemia.

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To synthesize advancements in the detection, treatment, and prevention of kidney cancer and summarize their effects globally, Fox Chase Cancer Center Urologic Oncology Fellow Laura Bukavina, MD, MPH, spearheaded a recent review on the topic.

The FDA has approved sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.

The combination of pembrolizumab plus carboplatin and paclitaxel demonstrated a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in the first-line treatment of patients with stage III/IV or recurrent endometrial cancer.

The MOUNTAINEER-03 trial is designed to evaluate the efficacy of tucatinib and trastuzumab plus modified leucovorin calcium, fluorouracil, and oxaliplatin, compared with standard-of-care, first-line therapy for metastatic HER2-positive colorectal cancer.

Ryan Jacobs, MD, highlighted the updated safety and efficacy results from the minimal residual disease cohort of the CAPTIVATE trial, discussed unanswered questions regarding minimal residual disease as a predictive vs prognostic tool in patients with chronic lymphocytic leukemia, and outlined areas that are ripe for further exploration.

Radiation plus docetaxel improved disease-free survival and overall survival vs radiation alone in patients with head and neck squamous cell carcinoma unsuitable for cisplatin-based chemoradiation, regardless of patients’ prespecified prognostic groups, according to findings from a phase 2/3 trial.

Laura Dawson, MD, FRCPC, discusses data from the NRG/RTOG 1112 trial examining the addition of stereotactic body radiation therapy to sorafenib, the implications of the data for the locally advanced hepatocellular carcinoma treatment paradigm, and next steps for research.

Timothy Burns, MD, PhD, discusses the evolution of EGFR-targeted non–small cell lung cancer treatments, the importance of delineating small cell lung cancer subtypes, and the advantages of continued antibody-drug conjugate development across all areas of lung cancer.

Amar U. Kishan, MD, discusses the safety results of MRI-guided SBRT compared with the current standard of care, highlights the benefits of using an MRI to guide radiation for patients with prostate cancer, and explains other areas where MRI-guided SBRT could explored.

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A new study by researchers at Washington University School of Medicine in St. Louis found that undergoing more frequent computed tomography scans was not associated with improved outcomes following lung cancer surgery.

Stephanie A. Berg, DO, highlights ongoing urothelial cancer clinical trials; the role of single-agent immunotherapy and combinations in this disease; and the importance of future research that prioritizes and guides individualized patient care.

For Kevin Kalinsky, MD, MS, director of breast medical oncology at the Winship Cancer Institute of Emory University in Atlanta, Georgia, his work on the RxPONDER trial serves as one of a few accomplishments for which he is grateful that have impacted clinical care.

John H. Strickler, MD, highlights key findings from the MOUNTAINEER trial and addresses the possibility of moving the combination up to the first line setting.

In recommendations released January 27, 2023, the National Comprehensive Cancer Network now advises physicians to consider neratinib for patients with HER2-negative metastatic breast cancer, regardless of estrogen receptor status, with activating mutations in the HER2 gene as detected by next-generation sequencing of tumor tissue or circulating tumor DNA.

Six weeks of preoperative oxaliplatin-fluoropyrimidine chemotherapy did not increase perioperative morbidity in patients with radiologically staged T3-4, N0-2, M0 colon cancer, according to findings from the international phase 2/3 FOxTROT trial.

The FDA has granted an orphan drug designation to BEA-17 for the treatment of patients with glioblastoma.

Atish D. Choudhury, MD, PhD, discussed the significance of these trials within the metastatic castration-resistant prostate cancer treatment landscape, highlighted investigative PARP inhibitor combinations, and emphasized the need for further research in this area to determine which patients are most likely to benefit from certain therapies based on their molecular profiles.

Press Release
A three-drug combination that sent chronic lymphocytic leukemia into deep remissions in a broad group of patients in a clinical trial is highly effective in patients with high-risk forms of the disease, a new, phase 2 clinical trial led by Dana-Farber Cancer Institute investigators indicates.

A biologics license application seeking the approval of remestemcel-L has been resubmitted to the FDA for the treatment of pediatric patients with steroid-refractory, acute graft-vs-host-disease.

The treatment of patients with early-stage non–small cell lung cancer is rapidly evolving across the spectrum of care, particularly in the neoadjuvant setting, where evidence in favor of systemic chemoimmunotherapy regimens is growing.

Nicholas P. McAndrew, MD, MSCE, discusses the need for HER2-targeted TKIs specifically designed to penetrate the blood-brain barrier, updated clinical data on the safety and tolerability of DZD1516 monotherapy, and the implications of nonclinical data on DZD1516 for treating CNS metastases in HER2-positive breast cancer.

The FDA has granted orphan drug exclusivity to sodium thiosulfate injection, which is indicated to reduce the risk of platinum-induced ototoxicity in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Martin Dreyling, MD, discusses the safety and efficacy data from the TRIANGLE study done in patients with previously untreated MCL who are younger than 66 years, and the impact of these results on the use of ASCT in this population.