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Devyser’s Gene Screening Test for Breast, Ovarian Cancers Approved in Europe

Devyser’s Gene Screening Test for Breast, Ovarian Cancers Approved in Europe

Devyser’s hereditary breast and ovarian cancer (HBOC) test has received a CE mark from the European Commission and is now approved as a diagnostic test for both cancers in Europe. The CE mark is a certification for products sold in the European Economic Area to indicate the product has met all legal standards, and has been evaluated to meet…

Fewer, Higher Doses of Radiation Therapy Safe for Early Breast Cancer

Fewer, Higher Doses of Radiation Therapy Safe for Early Breast Cancer

For people with early breast cancer, delivering radiation therapy in fewer, larger doses does not increase the risk of long-term side effects from treatment, a new study demonstrates. The study, “Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer,” was published in the Journal of Clinical Oncology. Radiation therapy,…

New Light-activated CAR T-cells May Help Reduce Therapy Side Effects

New Light-activated CAR T-cells May Help Reduce Therapy Side Effects

Scientists have developed a new CAR T-cell immunotherapy strategy that uses light to activate the immune cells specifically in cancerous regions. The approach, which worked well in mice, may help reduce treatment-related side effects in cancer patients. The study, “Engineering light-controllable CAR T cells for cancer immunotherapy,” was published in the journal Science Advances. Chimeric…

Phase 3 Trial Launched to Test Cabometyx-Tecentriq in Advanced Kidney Cancer

Phase 3 Trial Launched to Test Cabometyx-Tecentriq in Advanced Kidney Cancer

Exelixis has launched a Phase 3 trial that will investigate the safety and efficacy of a combination therapy of Cabometyx (cabozantinib) and Tecentriq (atezolizumab) in people with advanced renal cell carcinoma (RCC) whose cancer progressed while being treated with an immune checkpoint inhibitor or shortly thereafter. The pivotal study, called CONTACT-03 (NCT04338269), aims to enroll approximately 500…

CAR T-cell Therapy Tecartus Granted FDA Approval for Mantle Cell Lymphoma

CAR T-cell Therapy Tecartus Granted FDA Approval for Mantle Cell Lymphoma

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Kite Pharma’s CAR T-cell therapy Tecartus (brexucabtagene autoleucel) for adults with relapsed or refractory mantle cell lymphoma (MCL). The decision comes less than six months after the FDA accepted to analyze, under priority review status, Kite’s biologics license application, shortening review time from the standard 10…

Yale Researcher Wins NIH Merit Award, Supporting Immunotherapy Work

Yale Researcher Wins NIH Merit Award, Supporting Immunotherapy Work

The National Institutes of Health (NIH) has given an R37 Merit Award to support the work of Kurt Schalper, MD, PhD, in the field of immunotherapy for the next seven years. An estimated 5% of all NIH-funded researchers are selected to receive this multiyear merit award. Schalper, an assistant professor of pathology and medicine at…

FDA Approves Tecentriq Combo for Certain Advanced Melanomas

FDA Approves Tecentriq Combo for Certain Advanced Melanomas

The U.S. Food and Drug Administration (FDA) has approved the immunotherapy Tecentriq (atezolizumab), in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib), for the treatment of BRAF V600 mutation-positive advanced melanoma. The decision comes after promising findings from IMSPIRE150 (NCT02908672), a Phase 3 trial in which the triple combination significantly extended the time patients lived without signs…

Sarclisa Triple Combo Prolongs Life Without Disease Progression in Some Myeloma Patients, Interim Data Show

Sarclisa Triple Combo Prolongs Life Without Disease Progression in Some Myeloma Patients, Interim Data Show

A combination of Sarclisa (isatuximab) plus standard Kyprolis (carfilzomib) and dexamethasone treatment significantly delays disease progression or death in people with relapsed or refractory multiple myeloma, interim results from a Phase 3 clinical trial suggest. The findings were shared at the European Hematology Association (EHA) 2020 Virtual Congress, in a presentation titled, “Isatuximab plus carfilzomib and dexamethasone…

EU Approval Urged for GSX’s Belantamab Mafodotin for Heavily Treated Myeloma

EU Approval Urged for GSX’s Belantamab Mafodotin for Heavily Treated Myeloma

GlaxoSmithKline’s investigational therapy belantamab mafodotin has been recommended for approved in the European Union, by the Committee for Medicinal Products for Human Use (CHMP), for heavily treated multiple myeloma patients. The marketing authorization application, accepted for review in February, is specific for people with relapsed or refractory disease who were previously treated with an immunomodulatory agent, a proteasome…

First Patient Dosed in Trial Testing Belantamab Mafodotin, Nirogacestat Combo in RRMM Patients

First Patient Dosed in Trial Testing Belantamab Mafodotin, Nirogacestat Combo in RRMM Patients

A Phase 1b clinical trial evaluating GlaxoSmithKline (GSK)’s belantamab mafodotin, in combination with SpringWorks Therapeutics’ nirogacestat, in people with relapsed or refractory multiple myeloma, has dosed its first patient, SpringWorks announced. The safety and preliminary effectiveness of this combination are being assessed as a sub-study in GSK’s ongoing DREAMM-5 platform trial (NCT04126200). “We are delighted to…