The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending marketing authorization of Onivyde (irinotecan liposome injection, nal-IRI), in combination with 5-fluorouracil and leucovorin, for the treatment of metastatic adenocarcinoma of the pancreas in adult patients who have progressed following gemcitabine based therapy.
GlaxoSmithKline and the University of Leicester in the U.K. will collaborate to discover and develop novel medicines to treat high-grade non-Hodgkin’s lymphoma. The project is part of GSK’s Discovery Partnerships with Academia initiative. Professor Simon Wagner, from the Department of Cancer Studies, who is leading the project on behalf of the University of Leicester, said:... […]
Kisplyx (lenvatinib), in combination with everolimus, received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor targeted therapy. The opinion was based on results from a phase II trial that showed... […]
Health Canada approved Imbruvica (ibrutinib) as an oral, once-daily, single-agent targeted therapy for previously untreated patients with active chronic lymphocytic leukemia. This is the fourth Canadian approval for Imbruvica, which is now approved for use in all lines of CLL therapy.
Eli Lilly and Company and Boehringer Ingelheim will collaborate on a phase Ib study that will evaluate the safety and tolerability of Lilly’s abemaciclib in combination with Boehringer Ingelheim’s BI 836845, in patients with HR+, HER2- metastatic breast cancer. According to the companies, the collaboration has the potential to expand to phase II trials in... […]
Guardant Health and OncoMed Pharmaceuticals will collaborate using Guardant Health’s digital sequencing technology to develop a custom blood test that looks for specific biomarkers relevant to OncoMed’s ongoing phase Ia/Ib trial of its anti-RSP03 antibody. RSPO3 gene overexpression, including RSPO3 gene fusions, appear to drive tumor growth in subsets of several cancers, including colon, ovarian,... […]
The U.K.’s National Institute for Health and Care Excellence recommended the use of Firmagon (degarelix) for men with advanced hormone-dependent prostate cancer with spinal metastases. This announcement follows a three-year review process and NICE’s most recent draft Appraisal Consultation Document published in June 2015, which recommended against the use of Firmagon within its marketing authorization... […]
FDA approved a premarket approval supplement application for Novocure’s second generation Optune system. The Tumor Treating Fields delivery system is now available to glioblastoma patients in the U.S. The new model features a generator that is less than half the weight and half the size of the generator in the first generation system. Additional improvements... […]
FDA granted Orphan Drug Designation to TK216 for the treatment of Ewing sarcoma. Oncternal Therapeutics Inc., the drug’s sponsor, is in the process of initiating a first-in-human phase I trial of TK216 in relapsed or refractory Ewing sarcoma. The company recently received Fast Track Designation in this indication. TK216 is a first-in-class small molecule that... […]
FDA granted a Rare Pediatric Disease Designation to ABT-414, an investigational antibody drug conjugate targeting the epidermal growth factor receptor for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine Glioma, known to be highly aggressive and difficult to treat brain tumors found at the base of the brain. According to AbbVie, the drug’s... […]
