News

A Biologics License Application has been submitted to the FDA for the potential approval of naxitamab for the treatment of patients with relapsed or refractory high-risk neuroblastoma.

Cabozantinib demonstrated antitumor activity as treatment of patients with advanced Ewing sarcoma and osteosarcoma, warranting further investigation for a potential new therapeutic option for this patient population, according to findings from phase II CABONE study.

The FDA has provided clearance for the initiation of, and immediate enrollment for, a new phase II trial to explore the use of the investigational oncologic agent leronlimab in treating patients with coronavirus disease 2019 who experience mild to moderate respiratory complications.<br /> &nbsp;

The immunotherapeutic vaccine OSE-2101 demonstrated a favorable 12-month survival rate as second- or third-line treatment of patients with HLA-A2-positive advanced non&ndash;small cell lung cancer, meeting the primary end point of overall survival in the phase III Atalante 1 study, according to a press release from the drug developer, OSE Immunotherapeutics, Inc.

Although fludarabine, cyclophosphamide, and rituximab may be efficient in inducing remission for the treatment of patients with Binet A high-risk chronic lymphocytic leukemia, recent data published in&nbsp;Leukemia&nbsp;suggest there is no evidence that this would be better than the current standard of care, which is the &ldquo;watch and wait&rdquo; approach.

A rolling New Drug Application has been submitted for pralsetinib as treatment of patients with RET fusion–positive non–small cell lung cancer, according to a press release from Blueprint Medicines Corporation.

The FDA has granted a priority review to a Biologics License Application for remestemcel-L, an allogeneic cell therapy for the treatment of children with steroid-refractory acute graft-versus-host disease, according to a press release from Mesoblast Limited.

A New Drug Application has been submitted to the FDA for the vascular endothelial growth factor tyrosine kinase inhibitor tivozanib for the treatment of patients with relapsed or refractory renal cell carcinoma, according to a press release from AVEO Oncology.

In honor of Colorectal Cancer Awareness Month,&nbsp;<em>Targeted Oncology</em>&nbsp;was joined by Pashtoon M. Kasi, MD, MBBS, MS, in a tweet chat. The 3 featured cases highlighted a variety of subsets of CRC, including patients with NTRK fusions,&nbsp;<em>BRAF</em>&nbsp;mutations, and HER2 amplifications.

The FDA has granted Fast Track Therapy designation to ME-401, an investigational selective oral inhibitor of phosphatidylinositol 3-kinase inhibitor as treatment of patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.

In the neoadjuvant setting, physicians treating resectable pancreatic cancer have more treatment options than ever before. Recently, however, the routine use of radiotherapy has been called into question, leading to a debate at the 5th Annual School of Gastrointestinal Oncology,&nbsp;hosted by Physicians&rsquo; Education Resource, LLC.

In an interview with&nbsp;Targeted Oncology,&nbsp;Prasad S. Adusumilli, MD, FACS, discussed the expansion of chimeric antigen receptor T-cell research in the solid tumor space and the challenges researchers will need to overcome in order to make this therapy effective for patients outside of the hematologic treatment landscape.

In an interview with <em>Targeted Oncology</em> at the 5th Annual School of Gastrointestinal Oncology, Jonathan Strosberg, MD explained the importance of having multidisciplinary teams when treating patients with neuroendocrine tumors.

A statistically significant improvement in the total pathologic complete response rate, the primary end point of the study, was observed with neoadjuvant treatment of pertuzumab, trastuzumab and docetaxel compared with placebo, trastuzumab, and docetaxel in Asian patients with&nbsp;<a><em>ERBB2</em></a>&nbsp;-positive early or locally advanced breast cancer, according to the phase III PEONY trial.

A Biologics License Application has been submitted to the FDA for the investigational B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy idecabtagene vicleucel as treatment of patients with multiple myeloma who have received at least 3 prior therapies.

COA conducted a webinar on the impact of COVID-19 on oncology practices and introduced several experts across the nation to share how their institutions have adjusted during this time to accommodate patients.

Chemotherapy demonstrated superior progression-free survival to multiple EGFR tyrosine kinase inhibitors as first- or second-line treatment of patients with&nbsp;EGFR-mutant exon 20 non&ndash;small cell lung cancer. This finding is based on results from the largest real-world study of patients with&nbsp;EGFR&nbsp;exon 20 mutations conducted in China.

An association was found between a lower risk of grade 3 or higher chemotherapy toxicity with higher body mass indexes and normal albumin, a protein made in the liver, levels in older adult patients with solid tumors, according to an analysis of a prospective, multicenter study.

A phase II trial of ficlatuzumab, an investigational HGF inhibitory antibody, in patients with relapsed and refractory acute myeloid leukemia joins the growing list of clinical trials halted due to the coronavirus disease 2019 pandemic.

Subcutaneous daratumumab, a monoclonal antibody was determined to be non-inferior to FDA approved intravenous daratumumab in terms of efficacy and pharmacokinetics as treatment of patients with relapsed or refractory multiple myeloma, according to results from the phase III COLUMBA trial. The study also showed an improved safety profile with SC versus IV daratumumab.

A sudden surge in the cases of COVID-19 due to pandemic, along with efforts to contain it, has led to multiple challenges that no country has experienced in the last several decades. The global pandemic from COVID-19 poses a unique set of challenges not only for patients with cancer who need their treatment, but also for caregivers, oncologists, and the overall care team.

The FDA has approved&nbsp;durvalumab in combination with&nbsp;standard-of-care chemotherapy&nbsp;as a&nbsp;frontline&nbsp;treatment for&nbsp;adult&nbsp;patients with extensive-stage small cell lung cancer.

At the Annual Education Summit of the Medical Oncology Association of Southern California, Tanya Dorff, MD, discussed evolving practices in prostate and urothelial cancers as well as highlighted controversies in the treatment landscape such as the role of combination therapy in prostate cancer.

The use of genetic testing by way of tumor tissue analysis combined with liquid biopsy monitoring at different time points throughout the disease progression of colorectal cancer may help optimize treatment selection.

Targeted Oncology reviews trending news and videos online for the week of March 27, 2020, including recent updates on the impact of COVID-19 in oncology practice and a clinical trial on breast cancer.

An updated analysis from the ALCYONE trial has found that adding daratumumab to a standard-of-care regimen significantly prolonged survival in patients with transplant-ineligible multiple myeloma, according to a recent paper in The Lancet.

In a&nbsp;Targeted Oncology case-based peer perspectives live discussion, Heather A. Wakelee, MD, discussed treatment with tyrosine kinase inhibitor treatment options for a real-world Hispanic patient with EGFR-mutant non&ndash;small cell lung cancer.<br /> &nbsp;

Melphalan flufenamide in combination with dexamethasone achieved an overall response rate of 26% in patients with relapsed/refractory multiple myeloma, according to results from the pivotal phase II HORIZON study. The achievement serves as basis for the submission of a New Drug Application to the FDA.

In an interview with&nbsp;Targeted Oncology, James L. Ferrara, MD, discussed the prognosis of patients with graft-versus-host-disease and the current treatment strategies. He also highlighted his experience with ruxolitinib and the remaining challenges in this space.

Treatment with an investigational targeted anti-cancer gene-therapy agent, VB-111, in addition to paclitaxel met the pre-specified efficacy criterion of an absolute percentage advantage of 10% or higher CA-125 response rate in patients with platinum-resistant ovarian cancer, according to results from the planned interim analysis of the phase III OVAL trial.<br /> &nbsp;