The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Axsome Therapeutics‘ AXS-05, an investigational oral therapy for the treatment of agitation in people with Alzheimer’s disease. This designation is intended to accelerate the development and review of potential therapies for serious diseases. It is awarded upon clinical evidence of substantial improvement…
The combination therapy of melflufen (melphalan flufenamide) and dexamethasone continues to be safe and to elicit deep and durable responses in hard-to-treat patients with relapsed or refractory multiple myeloma, top-line data from a Phase 2 clinical trial shows. The findings will support Oncopeptides‘ submission of a new drug application requesting accelerated approval of melflufen for treating relapsed…
The U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) as a treatment for people with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) — the second most common form of skin cancer — that is not curable by surgery or radiation therapy. The decision was based on data from a Phase 2 trial called…
The U.S. Food and Drug Administration (FDA) has granted priority review to the new drug application (NDA) Myovant Sciences submitted earlier this year requesting the approval of relugolix for the treatment of men with advanced prostate cancer. The priority review status will shorten relugolix’s regulatory review for this indication from the standard 10 months to…
A team at Griffith University’s Institute for Glycomics in Australia has received $300,000 in funding from The Bourne Foundation, as well as a further funding pledge from Tour de Cure, to advance research into the development of blood tests for the early diagnosis of ovarian cancer. “Despite decades of research, there is currently no easily accessible, non-invasive and…
Belantamab mafodotin, GlaxoSmithKline’s investigational antibody-drug conjugate, continues to show promise when used alone or in combination with other approved therapies to treat people with relapsed or refractory multiple myeloma, according to data from two clinical trials. Findings from both trials — DREAMM-2 (NCT03525678) and DREAMM-6 (NCT03544281) — were presented in two posters at the recent…
The Chinese National Medical Products Administration (NMPA) has approved Keytruda (pembrolizumab) as a second-line therapy for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors have at least 10% of cells producing the PD-L1 protein. With the new approval, Keytruda is now available in China for five indications across three different…
Scientists used a new imaging technique to assess the structure of amyloid-beta aggregates — known culprits in Alzheimer’s development — that are present inside nerve cells at early stages of the disease, a study reports. These findings, from a mouse model, may be important to understanding the different stages of Alzheimer’s progression. The study, “Super‐Resolution Infrared Imaging of…
The U.S. rates of advanced prostate cancer continued to rise in men 50 and older after the U.S. Preventive Services Task Force (USPSTF) recommended in 2012 against prostate-specific antigen (PSA)-based screening for all men, an American Cancer Society study shows. Notably, the annual increase in men ages 50–74 with the most advanced stage disease after…
Investigators using targeted proteomics — a technique to detect proteins of interest — on samples of ovarian cancer found a wide variety of biomarkers that might help predict which chemotherapies patients are more likely to respond to, the precision medicines company mProbe reported. Identifying these tumor biomarkers is crucial not only to spotting potential targets for future therapies, but also…
