Boehringer Ingelheim’s Phase III treatment for the rare bone and blood cancer acute myeloid leukemia cleared the FDA’s requirements for a breakthrough designation therapy. The drug maker said Tuesday that the polo-like kinase inhibitor named volasertib offers a new mode of action, and success could help older patients who cannot pursue the typical AML remission induction therapy that involves high doses of chemotherapy. The treatment‘s goal is to stop the cancer by inducing cell death by targeting an enzyme associated with cell division.
Sanofi is ankle-deep in EU approvals. The European Commission approved the company’s MS drug Lemtrada for relapsing remitting multiple sclerosis, PMLive reported Monday. This is in addition to giving the all-clear in August for the company to market the MS oral Aubagio. PMLive notes that while Novartis has been able to market Gilenya in the region since 2011, these approvals give it an edge over Biogen Idec’s Tecfidera, which has been tied up with patent and data protection issues.
GlaxoSmithKline is no longer pursuing the experimental Crohn’s disease drug vercirnon, reports FierceBiotech, which tracked down results on ClinicalTrials.gov and saw “Terminated” next to three Phase III trials. The move follows last month’s announcement that GSK put the drug on hold after data showed it failed to meet its Phase III targets.
Teva signed a multi-year deal with Cancer Research Technology and the charity Cancer Research UK to explore cancer drugs that protect cells from chemotherapy damage, a strategy the trio described in a statement as “an in-built antidote to the toxic effect of the anti-tumor drug.” The agreement covers new target validation through compound creation, and will tap into Cancer Research UK’s network of institutes which includes Oxford’s Gray Institute, London Research Institute and Glasgow’s Beatson Institute.