A dual immunotherapy regimen of Opdivo (nivolumab) and Yervoy (ipilimumab) can prolong the survival of patients with untreated, inoperable malignant pleural mesothelioma (MPM), according to data from a Phase 3 clinical trial. Findings from this study about MPM, a severe form of cancer of the pleura (the protective lining surrounding the lungs), were presented by Bristol…
XPro1595, an investigational therapy by INmune Bio, can lower brain inflammation in people with mild to moderate Alzheimer’s disease, according to interim results of a clinical trial. Specifically, the Phase 1b clinical trial (NCT03943264) shows evidence that XPro1595 decreases white matter free water, a biomarker of neuroinflammation measured by magnetic resonance imaging (MRI). XPro1595 was…
The first patients have been injected in a Phase 3 trial investigating the safety and performance of Blue Earth Diagnostics‘ imaging agent rhPSMA-7.3 (18F) in detecting prostate cancer in men with suspected disease recurrence, the company announced. The SPOTLIGHT trial (NCT04186845) is recruiting patients at several sites in the U.S. and at a single site in Finland.…
Elevar Therapeutics and Tanner Pharma Group have partnered to make Apealea (paclitaxel micellar) accessible in areas outside the U.S. where the medication is not available. The companies have created a global named patient program, also known as an early or expanded access program, which provides physicians with a framework to legally and ethically prescribe investigational…
The U.S. Food and Drug Administration (FDA) has accepted to review two new Merck applications requesting the approval of Keytruda (pembrolizumab) for the treatment of patients with different forms of triple-negative breast cancer (TNBC). One of the two supplemental biologics license applications (sBLAs) was granted priority review, which speeds FDA action, with a Prescription Drug User…
The U.S. Food and Drug Administration (FDA) has accepted and given priority review designation to Biogen‘s application requesting the approval of aducanumab (BIIB037) for the treatment of Alzheimer’s disease. While the Prescription Drug User Fee Act (PDUFA) action date is set for March 7, 2021 — meaning a decision is due by then — the agency said it…
Bristol Myers Squibb and Bluebird Bio have resubmitted a biologics license application (BLA) with additional information requested by the U.S. Food and Drug Administration to consider the approval of idecabtagene vicleucel (ide-cel) for adults with hard-to-treat multiple myeloma. According to a press release, the BLA now includes further details on the CAR T-cell therapy’s chemistry, manufacturing, and control — a module necessary to…
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Blenrep (belantamab mafodotin-blmf), a first-in-class treatment for heavily pretreated adults with relapsed or refractory multiple myeloma, its developer, GlaxoSmithKline, announced. The approval is specific for people who have been given at least four previous therapies, including a CD38 inhibitor, a proteasome inhibitor, and an immunomodulatory…
Fate Therapeutics will soon initiate a Phase 1 trial investigating its CAR T-cell therapy, FT819, across several B-cell cancers, including chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), and non-Hodgkin’s lymphoma (NHL). The announcement follows the clearance of Fate’s investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA). The trial will…
The addition of Tecentriq (atezolizumab) to first-line treatment with Avastin (bevacizumab) and chemotherapy does not significantly extend survival without disease worsening in people with newly-diagnosed advanced ovarian cancer, a recent trial shows. While the IMagyn050 Phase 3 trial (NCT03038100) failed to meet one of its primary endpoints, researchers are gathering more data to determine whether…
