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Response to Checkpoint Inhibition in Urothelial Cancer May Be Affected by Autoimmune Events
July 2nd 2019The development of an immune-related adverse event was associated with improved patient response in an FDA analysis of patients with advanced urothelial cancer treated with a PD-1/PD-L1 inhibitor.
Regorafenib Plus Nivolumab Limits Tumor Growth In Gastric and Colorectal Cancers
July 2nd 2019In an interview with <em>Targeted Oncology</em>, Shota Fukuoka, MD, PhD, of the Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan, commented on the results of the study and the future plans to expand the research with a larger cohort.
Neratinib Combo Seeking FDA Approval in HER2+ Metastatic Breast Cancer
July 1st 2019A supplemental New Drug Application has been submitted to the FDA for the potential approval of neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have progressed on 2 or more prior HER2-targeted treatments.
Inaugural Cancer Research Institute STAR Awards Scientists Studying Cancer Immunology
July 1st 2019The Cancer Research Institute announced 5 US scientists accepted into their inaugural CRI Lloyd J. Old STAR Program for taking on potentially transformative research in cancer immunology. The scientists were announced at the CRI’s recent “Immuno-Oncology: A Future Look” event at the New York Academy of Sciences, which also recognized and celebrated the seventh annual Cancer Immunotherapy Month.
A Look Back at FDA News from June 2019
July 1st 2019In June 2019, the FDA approved a number of agents many fields, including diffuse large B-cell lymphoma, head and neck squamous cell carcinoma, small cell lung cancer, gastroenteropancreatic neuroendocrine tumors, and multiple myeloma. The FDA also approved the fifth biosimilar for trastuzumab and another biosimilar for bevacizumab across several indications.
Phase III Shows Benefit With Olaparib in Platinum-Sensitive BRCA+ Relapsed Ovarian Cancer
June 30th 2019In an interview with <em>Targeted Oncology, </em>Richard T. Penson, MD, discussed the significance of the findings recently presented for the SOLO3 trial in patients with platinum-sensitive, relapsed <em>BRCA-</em>positive ovarian cancer.
Cristofanilli Reviews CDK 4/6 Inhibitors in the Case of a Patient With ER-Positive Breast Cancer
June 29th 2019During a recent <em>Targeted Oncology </em>case-based peer perspectives live dinner event, Massimo Cristofanilli, MD, explained the options for treatment based on the case scenario of a woman with ER-positive breast cancer.<br />
Meta-Analysis Reviews Risk of Subsequent Malignancies After Thyroid Cancer
June 28th 2019An updated systematic review and new meta-analysis of the incidence of subsequent malignant neoplasms following thyroid cancer has found that there was no significant increased relative risk of breast cancer, salivary cancer, or combined hematologic malignancies based on whether or not patients had received radioactive iodine.
FDA Approves Bevacizumab Biosimilar Zirabev
June 28th 2019The FDA has approved Zirabev, a biosimilar to bevacizumab for 5 indications. Zirabev has been approved for the treatment of patients with metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non–small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer.
Upfront Daratumumab/Rd Combo Approved by FDA for Transplant-Ineligible Myeloma
June 28th 2019The frontline combination of daratumumab with lenalidomide and dexamethasone has been approved by the FDA for the treatment of patients with multiple myeloma who are ineligible for autologous stem cell transplantation.
Frontline Treatment With Lenalidomide Plus R-CHOP May Benefit Select Patients With DLBCL
June 27th 2019Lenalidomide plus standard R-CHOP immunochemotherapy may help select patients with activated B-cell-type diffuse large B-cell lymphoma who have a poor prognosis, based on data from the phase III ROBUST trial presented at the 2019 International Conference on Malignant Lymphoma.<br />
Durvalumab and Chemotherapy Improves OS in Extensive-Stage SCLC
June 27th 2019Frontline durvalumab led to a statistically significant and clinically meaningful improvement in overall survival (OS) in combination with etoposide and platinum-based chemotherapy in patients with extensive-stage small cell lung cancer, according to the results of a planned interim analysis of the phase III CASPIAN trial.
Turk Discusses Modern Thyroid Cancer Pathology and Management
June 27th 2019In an interview with <em>Targeted Oncology</em>, Andrew Turk, MD, discussed his presentation at the <em>3rd Annual</em> Congress on Oncology and Pathology as well as the current state of molecular testing for thyroid cancer and the future of testing and diagnostics.
New Agent Shows Synergy With JAK Inhibitor in Myelofibrosis After Ruxolitinib Failure
June 27th 2019In an interview with <em>Targeted Oncology, </em>Marina Kremyanskaya, MD, PhD, discussed the results from the phase II trial investigating the effects of CPI-0610 with or without ruxolitinib in patients with MF. Overall, the drug was well tolerated and effective in patients who had previously progressed on ruxolitinib or received inadequate responses to treatment.
BLU-667 Continues to Show Durable Responses in RET-Altered Thyroid Cancers
June 26th 2019The RET inhibitor BLU-667 induced durable responses in patients with advanced, <em>RET-</em>altered medullary thyroid cancer and papillary thyroid cancer, according to updated results of the ARROW trial focused on the patients with thyroid cancer that were presented at the 2019 ASCO Annual Meeting.
High Response Rate Seen With Concurrent Ibrutinib Plus CAR T-Cell Therapy in High-Risk CLL
June 26th 2019Significant activity was observed when ibrutinib was administered concurrently with CD19-directed CAR T-cell therapy compared with separately in patients with high-risk relapsed/refractory chronic lymphocytic leukemia who had progressed on or were intolerant of ibrutinib. Data presented at the 15th International Conference on Malignant Lymphoma show a high response rate with this concurrent treatment.
Expert Discusses Combinations, Other Research for the Treatment of Indolent Lymphomas
June 26th 2019Mitchell Smith, MD, PhD, discussed the most recent research and agents under investigation for the treatment of indolent lymphomas. He also highlighted how conversations transpire when discussing the watch-and-wait approach with his asymptomatic patients.
KEYNOTE-189 Updates Show Improved Outcomes for Metastatic Nonsquamous NSCLC
June 26th 2019In an interview with <em>Targeted Oncology, </em>Shirish Gadgeel, MBBS, of the Department of Medicine, Hematology/Oncology Division, University of Michigan, discussed recent study updates from the phase III KEYNOTE-189 trial and potential implications for the combination on clinical practice.
Fidler Examines a Case of NSCLC With Rapid Progression on Standard Frontline Therapy
June 26th 2019During a recent <em>Targeted Oncology </em>live case-based peer perspectives presentation, Mary Jo J. Fidler, MD, reviewed treatment options in the first and second line based on a case study of a patient with NSCLC who experiences rapid progression on her first-line regimen.
Ibrutinib Maintenance Appears Safe in MCL Following Induction Therapy
June 25th 2019Ibrutinib as a maintenance therapy for patients with mantle cell lymphoma who respond to frontline induction therapy with or without autologous stem cell transplant appeared safe and feasible, according to the results of a recent study presented at the 2019 ASCO Annual Meeting.
PFS Not Improved With Atezolizumab/Cobimetinib Combo in Phase III IMspire170 Trial
June 25th 2019The phase III IMspire170 trial failed to meet its primary endpoint according to topline results from the study. The combination of atezolizumab and cobimetinib did not improve progression-free survival compared with pembrolizumab in patients with previously untreated<em> BRAF </em>V600 wild-type melanoma.
Prefilled Syringe of Lanreotide Approved for GEP-NETs by FDA
June 25th 2019A prefilled syringe of lanreotide has been approved by the FDA to enable healthcare providers to administer the injection easier to adults with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.
Niraparib Granted FDA's Priority Review for Advanced Ovarian Cancer
June 25th 2019A priority review designation has been granted by the FDA to a supplemental biologics license application for niraparib as a treatment for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 prior chemotherapy regimens, and who have either a <em>BRCA </em>mutation or have homologous recombination deficiency and progressed >6 months after their last platinum-based regimen.
Partial Clinical Hold Lifted for One Venetoclax Trial in Multiple Myeloma
June 24th 2019The FDA has lifted a partial clinical hold placed on the phase III CANOVA trial, which is investigating the combination of venetoclax and dexamethasone in comparison with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma and a transformation (11;14) abnormality.
Phase III CheckMate 459 Trial in Unresectable HCC Misses Primary Endpoint
June 24th 2019Topline results from the phase III CheckMate 459 trial revealed that the trial did not meet its primary endpoint of improved overall survival with nivolumab as compared with sorafenib for the treatment of patients with newly diagnosed, unresectable hepatocellular carcinoma.