A less-frequent, fixed dose regimen of Imfinzi (durvalumab) has been approved in the European Union and U.K. to treat adults with locally advanced, inoperable non-small cell lung cancer (NSCLC), announced the therapy’s developer, AstraZeneca. This new dosing option, which will reduce the need for medical appointments, will be available to NSCLC patients weighing more than…
Axsome Therapeutics has launched a Phase 3 trial that will assess the safety and efficacy of AXS-05, the company’s investigational oral treatment for agitation associated with Alzheimer’s disease. If positive, data from the trial is expected to support Axsome’s submission of an application requesting the therapy’s approval for treating Alzheimer’s patients with agitation. According to…
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Harpoon Therapeutics‘ investigational immunotherapy HPN217 as a possible treatment of multiple myeloma. The designation encourages the development of potential therapies for rare and serious diseases by granting them various financial and regulatory benefits. These include exemptions from certain fees, trial protocol assistance, and seven years…
Mindfulness can significantly improve brain health and pain perception in breast cancer survivors, according to a small Canadian study. The findings suggest that an eight-week mindfulness intervention can reduce activity in parts of the brain related to pain and to emotional reactivity (having a heightened emotional response to something unpleasant). The study, “Reduced Emotional Reactivity…
The first participant has been dosed in a Phase 3 trial investigating a triple combination of melflufen (melphalan flufenamide) plus dexamethasone and under-the-skin Darzalex (daratumumab) in people with heavily treated multiple myeloma. The trial, dubbed LIGHTHOUSE (NCT04649060), had been delayed by the COVID-19 pandemic but is now recruiting an estimated 240 participants, ages 18 and…
ADP-A2M4, an investigational therapy that uses engineered immune cells to fight cancer, showed an acceptable safety profile and promising effectiveness in people with synovial sarcoma, a rare cancer that develops around the joints and tendons, new clinical trial data show. The findings were presented at the Connective Tissue Oncology Society (CTOS) annual meeting by trial…
The prescribing information for Nubeqa (darolutamide) — used to treat men with prostate cancer that has not spread to other parts of the body — will be updated to include overall survival data for patients with non-metastatic castration-resistant prostate cancer (nmCRPC), according to Bayer, one of the therapy’s developers. Specifically, data demonstrating that Nubeqa lowers…
Combining the experimental vaccine galinpepimut-S (GPS) with the immune checkpoint inhibitor Keytruda (pembrolizumab) induces promising responses in people with metastatic ovarian cancer who failed one or two prior lines of treatment, early data from a Phase 1/2 trial show. The combination kept all eight patients in a first evaluated group in the trial (NCT03761914) without signs…
Roche has launched a diagnostic genetic test to detect mutations in the PIK3CA gene in patients with advanced or metastatic breast cancer in the European Union. The cobas PIK3CA mutation test, performed in the lab (in vitro) and previously available for research purposes only, is now available in countries accepting the CE mark. “We are pleased to…
Donanemab (LY3002813), Eli Lilly’s experimental antibody-based immunotherapy, slowed cognitive and functional decline in patients at the earlier stages of Alzheimer’s disease, according to data from a Phase 2 trial. Findings from this trial, called TRAILBLAZER-ALZ (NCT03367403), also showed donanemab had a favorable safety profile, which was consistent with observations from previous clinical trials. “We are…
