News

The FDA has granted an accelerated approval to zanubrutinib for the treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy.

In an interview with Targeted Oncology, Jeffrey S.Weber, MD, PhD, discussed the 3-year efficacy and biomarker results from the phase III CheckMate 238 trial, which he presented at the 2019 European Society of Medical Oncology Congress.

A New Drug Application has been accepted and granted priority review by the FDA to the investigational agent selumetinib for the treatment of patients ≥3 years old with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas, according to a press release from AstraZeneca and Merck.

Although immune checkpoint inhibitor therapy has represented a paradigm shift in the treatment of multiple types of cancer, many patients’ cancers do not respond at all to these therapies or develop resistance after an initial period of response, according to Julie R. Brahmer, MD. 

In an interview with Targeted Oncology, Scott T. Tagawa, MD, discussed the findings from the TROPHY-U-O1 trial presented at the 2019 ESMO Congress and shared his thoughts on the next steps for sacituzumab govitecan.

In an interview with Targeted Oncology, John Simmons, PhD, discussed the potential role of liquid biopsy assays in predicting response to immune checkpoint inhibitor therapy for patients with cancer. He also highlighted other liquid biopsy assays that are in development for detecting MSI.

The advent of immunotherapy has delivered unprecedented and durable anti-tumor responses as well as long-lasting survival benefits in some patients. Yet many clinicians may not be familiar with managing the unique toxicities that accompany these emerging cancer treatments.

A supplemental New Drug Application for the combination of ibrutinib and rituximab has been submitted to the FDA for the first-line treatment of patients aged 70 years or younger with chronic lymphocytic leukemia or small lymphocytic lymphoma, according to a press release from ibrutinib developer, AbbVie.

In an interview with Targeted Oncology, Eytan M. Stein, MD, reviews the current treatment landscape of acute myeloid leukemia, underscores the importance of molecular monitoring, and highlights where the field is headed.

In an interview with Targeted Oncology during the 2019 Prostate Cancer Consensus Conference, James L. Mohler, MD, explained the reasons for changes to the NCCN guidelines on genetic testing and counseling in prostate cancer. He also discussed what needs to be addressed in the future to further increase knowledge of genetic testing and improve its use.

A supplemental Biologics License Application for the combination of nivolumab and ipilimumab for the treatment of patients with advanced hepatocellular carcinoma previously treated with sorafenib has been accepted by the FDA and given Priority Review status. The supplemental Biologics License Applicationwas given a Prescription Drug User Fee Act goal date of March 10, 2020, according to a press release from Bristol-Myers Squibb.<br /> &nbsp;

Apalutamide plus androgen deprivation therapy maintained health-related quality of life in patients with metastatic castration-sensitive prostate cancer in addition to showing positive overall survival and radiographic progression-free survival outcomes in the phase III TITAN trial, said Neeraj Agarwal, MD.

Although the use of PD-1 and CTLA-4 pathway blockade in non&ndash;small cell lung cancer has had mixed results in the past, the combination of nivolumab and ipilimumab has demonstrated positive benefit in overall survival and adverse event profile compared with chemotherapy. Research suggests that anti&ndash;CTLA-4 helps induce T-cell responses and anti&ndash;PD-1 aids to restore anti-tumor T cell function.

The combination of bemcentinib, a first in class selective AXL inhibitor, and pembrolizumab is well-tolerated in patients with composite AXL-positive non&ndash;small cell lung cancer, according to updated data presented at Society for Immunotherapy of Cancer&rsquo;s 34th Annual Meeting.

The use of CMP-001, an intratumoral toll-like receptor 9 agonist, is capable of triggering durable responses when used in combination with pembrolizumab for patients with PD-1 resistant metastatic melanoma according to results from a phase Ib study presented at the Society for Immunotherapy of Cancer&rsquo;s 34th Annual Meeting.

The anti&ndash;CD27 agonist, MK-5890, demonstrated acceptable safety findings when administered as monotherapy and in combination with pembrolizumab in numerous solid tumors, according to findings of an open-label phase I trial presented by Ronnie Shapira-Frommer, MD, head of the Onco-Gynecological Cancer Unit at The Ella Lemelbaum Institute for Immuno-Oncology, Ramat Gan, Israel, during the Society for Immunotherapy of Cancer&rsquo;s 34^th Annual Meeting.

The FDA has approved luspatercept-aamt for the treatment of anemia in adult patients with beta thalassemia who need regular red blood cell transfusions.

TT-00420, an investigational spectrum-selective multiple kinase inhibitor received an orphan drug designation from the FDA for the treatment of cholangiocarcinoma, TransThera Biosciences Co. Ltd announced in a press release.

In an interview with&nbsp;<em>Targeted Oncology</em>, Benjamin Weinberg, MD, discussed the treatment options available for the various subpopulations in mCRC.<br /> &nbsp;

The American Cancer Society has estimated that in 2019 in the United States, approximately 13,240 new patients will receive a diagnosis of cervical cancer and 4170 individuals will die from the disease. However, because of effective screening programs using cytology and/or high-risk human papillomavirus DNA testing in industrialized nations, incidence and mortality rates have declined.

In an interview with&nbsp;Targeted Oncology, Winston Tan, MD, discussed advances in thyroid cancer that may be competitors to the current standard of care. He also shared ongoing challenges that he has experienced in treating patients with thyroid cancer.

There are many greatdebates in the field of multiple myeloma, and one that is becoming increasingly relevant in the era of modern therapies is whether or not to treat patients with asymptomatic disease. While the etiology of MM remains unknown, a major advancement in understanding myeloma pathogenesis has been the observation that all patientsprogress, albeit at differing rates, through an asymptomatic phase of either monoclonal gammopathy of undetermined significance or smoldering MM.

In an interview with&nbsp;Targeted Oncology, Alan Bryce, MD, discussed the significance of the data from PROfound for men with mCRPC. He also highlighted findings from the CARD trial and where the field is headed in terms of targeted therapies versus chemotherapies.

Pegfilgrastim-bmez, a biosimilar of pegfilgrastim, is now FDA approved to decrease the incidence of infection caused by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive therapy, according to a press release from Sandoz Inc., a division of Novartis. LA-EP2006 is already being sold in Europe and the developer now plans to bring the drug to the United States this year.^&nbsp;<br /> &nbsp;

During a <em>Targeted Oncology </em>live case-based peer perspectives discussion, Ruben A. Mesa, MD, discussed risk assessment and treatment options available based on these assessments for patients with primary myelofibrosis with a group of physicians. Mesa, director of the UT Health San Antonio Cancer Center, explained these treatment options based on a case scenario of a patient with PMF.

Following a meeting with the FDA, AVEO Oncology has decided to push back the planned New Drug Application submission for tivozanib to the first quarter of 2020 and to narrow for the proposed indication for tivozanib to the treatment of relapsed or refractory renal cell carcinoma, according to a press release from the company.

Detailed results of the phase III ADMIRAL trial, which evaluated the use of gilteritinib in adult patients with FLT3 mutation&ndash;positive relapsed or refractory acute myeloid leukemia, have been published in the New England Journal of Medicine and reaffirm the improved overall survival rate seen with gilteritinib compared with chemotherapy in these patients, according to a press release from Astellas Pharma Inc.

The combination of pegylated human hyaluronidase with gemcitabine and nab-paclitaxel failed to improve the median overall survival in patients with metastatic pancreatic cancer, missing the primary endpoint of the phase III HALO-301 trial, Halozyme Therapeutics, Inc. reported in a press release.

Yuma Regional Medical Center Cancer Center has implemented a genetic cancer screening and testing for their patients through collaboration with Myriad Genetics, a molecular diagnostic testing company, according to a presentation by Erica Martinez, RN, OCN, at the Association of Community Cancer Centers&rsquo; 2019 National Oncology Conference. After partnering with Myriad Genetics, the cancer center saw a 4-fold increase in genetic testing of patients with cancer in the first 4 months, which led to a change in clinical management in 20% of those cases.

In an interview with&nbsp;<em>Targeted Oncology</em>, Arlene Siefker-Radtke, MD,&nbsp;examined the treatment landscape for bladder cancer and how factors like BCG shortages and prognoses in the elderly population are causing a shift toward novel immunotherapy agents.