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Survival Improved With the Addition of Chemotherapy for Small HER2-Positive Breast Cancer
April 23rd 2020"We know that, in general, patients with this particular subset of hormone-receptor-positive breast cancers should get chemotherapy, but all the studies showing the benefits of chemotherapy included patients with large cancers."
Ruxolitinib Significantly Improves Outcomes in Acute Graft-Versus-Host-Disease
April 23rd 2020“These new data from REACH2 showing superiority of Jakavi over current standard-of-care therapies add to a growing body of evidence on how targeting the JAK pathway can be an effective strategy in this difficult-to-treat condition."
Pembrolizumab sBLA Resubmitted to FDA With New Dosing Frequency
April 23rd 2020"The oncology community is rapidly adapting cancer care during the COVID-19 pandemic in order to minimize exposure and keep cancer patients as safe as possible. Now more than ever, we believe it is critical to pursue a six-week dosing schedule for Keytruda."
Updated Analysis Confirms Safety of Eryaspase in Advanced Metastatic Pancreatic Cancer
April 22nd 2020"The third independent safety review has once again confirmed the favorable safety profile of our lead product candidate eryaspase, and the trial has now surpassed 75% of the planned target enrollment."
Weber Evaluates the Role of Neoadjuvant and Adjuvant Immunotherapy in Melanoma
April 22nd 2020In an interview with Targeted Oncology, Jeffrey S. Weber, MD, PhD, discussed the role of neoadjuvant and adjuvant therapy for the treatment of patients with melanoma. He also highlighted the role of immunotherapy, as well as other types of therapy, in this treatment landscape.
FDA Grants Accelerated Approval to Sacituzumab Govitecan in mTNBC
April 22nd 2020"The approval of sacituzumab govitecan, the first ADC approved specifically for metastatic TNBC, an aggressive cancer with a poor prognosis and few effective therapies, will give clinicians a novel tool for treating patients with this disease."
Biosimilar for Trastuzumab Available for HER2-Overexpressing Breast Cancer, Gastric Cancers
April 22nd 2020“The launch of Ontrucant to deliver our first oncology biosimilar in the US marks an important milestone for Samsung Bioepis, and more importantly, for the patients who are in need of this proven treatment."
Ruxolitinib Phase III Trial Initiated for Treatment of COVID-19 Cytokine Storm
April 21st 2020“There is an unprecedented unmet medical need for treatments that prevent or reduce severe COVID-19 related complications to improve outcomes for patients and alleviate the overwhelming pressure on the global healthcare system."
FDA Approves cobas HPV Test for Measurement of Cervical Cancer Risk in Women with High-Risk HPV
April 21st 2020"The approval of our HPV test for the cobas 6800 and 8800 Systems enables molecular laboratories to achieve the efficiency and scale they need to meet the demands of high-volume cervical screening programs..."
Patients With Lung Cancer Considered at Higher Risk of Developing COVID-19
April 20th 2020"In the era of COVID-19, the optimal management of patients with lung cancer remains unknown and the oncology community should have increased awareness to prevent the emergence of an increase in cancer-related and infectious mortality."
Nivolumab/Ipilimumab Combo Improves OS in Malignant Pleural Mesothelioma
April 20th 2020“These topline results from the CheckMate 743 trial demonstrate the potential of Opdivo plus Yervoy in previously untreated patients with malignant pleural mesothelioma, and is another example of the established efficacy and safety of the dual immunotherapy combination seen in multiple tumor types.”
CheckMate-9ER Hits Efficacy Targets in Frontline Advanced RCC
April 20th 2020“The results from the pivotal CheckMate-9ER trial clearly demonstrate the combination of cabozantinib plus nivolumab provides a clinically meaningful benefit in the key efficacy measures of progression-free survival and overall survival for previously untreated kidney cancer patients.”
Talazoparib Toxicities Manageable in gBRCA-Mutated HER2-Negative Advanced Breast Cancer
April 20th 2020Safety data from the phase III EMBRACA trial were recently published. Talazoparib appears to be safe with manageable toxicities in patients with germline BRCA-mutated HER2-negative advanced breast cancer.
Indolent Non-Hodgkin Lymphomas Still Require More Durable Treatment Options
April 20th 2020In an interview with Targeted Oncology, Sonali M. Smith, MD, discussed the treatment landscape for patients with indolent non-Hodgkin lymphoma. In particular, she highlighted the data supporting the use of rituximab plus lenalidomide in patients with follicular lymphoma and marginal zone lymphoma.
AON Embraces Telehealth to Deliver Quality Cancer Care Even During the Pandemic
April 18th 2020In response to the coronavirus disease 2019 pandemic, the American Oncology Network has launched telehealth services across all of its sites. The use of telehealth technology will allow for patients to continue to receive convenient access to care and still help mitigate the spread of COVID-19.
FDA Grants Two Fast Track Designations to Surufatinib in Pancreatic and Extrapancreatic NETs
April 17th 2020The FDA granted two Fast Track designations to surufatinib for the treatment of both advanced and progressive pancreatic neuroendocrine tumors and extra-pancreatic NETs in patients who are not amenable for surgery, according to a press release from the developer, Chi-Med. The agent was previously granted Orphan Drug Designation by the FDA for this indication.
Liquid Biopsy Accurately Detects Early-Stage Pancreatic Ductal Adenocarcinoma
April 17th 2020A liquid biopsy test with the ability to screen for a panel of biomarkers rather than just one can reportedly detect pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer, in the early stages of disease.
Chemoradiation Companion AG013 Fails to Prevent Oral Mucositis in Head and Neck Cancer
April 17th 2020Treatment with AG013 for prevention of oral mucositis did not show statistical significance of severe oral mucositis duration in patients with head and neck cancer undergoing chemoradiation in comparison with placebo, missing the primary end point of the phase II clinical trial, according to early topline results announced in a press release from Oragenics, Inc.
FDA Approves Tucatinib Plus Trastuzumab/Capecitabine in HER2-Positive Breast Cancer
April 17th 2020The FDA granted accelerated approval for tucatinib tablets in combination with trastuzumab and capecitabine as treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases who have received one or more prior anti-HER2-based regimens in the metastatic setting. The approval comes 4 months ahead of the targeted action date from the FDA’s Real-Time Oncology Review.
RIBECCA Trial Confirms Role of Ribociclib Combination in HR+ HER2-Negative Breast Cancer
April 17th 2020In an interview with Targeted Oncology, Andreas Hartkopf, MD, discussed the findings from the RIBECCA trial and the key takeaways from these data for patients with HR-positive HER2-negative breast cancer.
Niraparib Grabs Regulatory Attention in China for Treatment of Advanced Ovarian Cancer
April 16th 2020Niraparib was granted Priority Review in China as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, by the National Medical Products Administration.
FDA Approves Novel Diagnostic Assay to Accompany Encorafenib in Treatment of mCRC
April 16th 2020The FDA has granted approval to the therascreen BRAF V600E Kit as a companion diagnostic to encorafenib, a BRAF inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer harboring a BRAF V600E mutation, as detected by an FDA approved test, in combination with cetuximab after prior therapy.<br />
First Patient Treated in Phase IIb/III Trial of Leronlimab for COVID-19
April 16th 2020The first severe and critically ill patient with coronavirus disease 2019 has been treated with leronlimab in a phase IIb/III clinical trial, announced CytoDyn Inc., developer of the drug. A total of 15 patients have also been enrolled to the phase II trial of patients with mild to moderate COVID-19.
Telemedicine Takes the Lead in Cancer Care Strategy During the COVID-19 Outbreak
April 16th 2020In an interview with Targeted Oncology, H. Jack West, discussed the role telemedicine has taken to support the treatment and post-treatment surveillance of patients with cancer during the COVID-19 pandemic.
Cabozantinib Improves Survival in Phase III METEOR Trial of Advanced Renal Cell Carcinoma
April 16th 2020Cabozantinib achieved improvements in the progression-free survival, overall survival, and objective response rate in patients with previously treated advanced renal cell carcinoma compared with everolimus, according to data from the phase III METEOR study.