The National Institute for Health and Care Excellence issued a Final Appraisal Determination recommending panitumumab as an option for patients with previously untreated, RAS wild-type metastatic colorectal cancer in adults in combination with the FOLFOX or FOLFIRI chemotherapy regimens.
EnGeneIC Ltd., a clinical stage biopharmaceutical company focused on developing its proprietary EDV nanocell platform for targeted cyto-immunotherapy in cancer, said FDA has granted Orphan Drug Designation to EGFR-targeted, doxorubicin-loaded EDV nanocells for the treatment of glioblastoma multiforme.
Agendia Inc. said its MammaPrint 70-Gene Breast Cancer Risk-of-Recurrence test is now included with the highest medical evidence level 1A in the latest version of AGO (German Association of Gynecological Oncology) guidelines for the care of breast cancer patients in Germany.
Lexicon Pharmaceuticals Inc. said FDA approved Xermelo (telotristat ethyl) 250 mg as a first and only orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog therapy in adults inadequately controlled by SSA therapyi.
Merck and Pfizer Inc. said FDA accepted for priority review the BLAfor avelumab for patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-based therapy.
Bristol-Myers Squibb announced that Columbia University Medical Center and Peter MacCallum Cancer Centre joined the International Immuno-Oncology Network (II-ON), a global peer-to-peer collaboration between BMS and academia that aims to advance immuno-oncology science and translational medicine to improve patient outcomes.
Exelixis Inc. and Bristol-Myers Squibb Co. entered into a clinical development collaboration to evaluate Cabometyx (cabozantinib), Exelixis' small molecule inhibitor of receptor tyrosine kinases, with BMS's Opdivo (nivolumab), either alone or in combination with Yervoy (ipilimumab).
Exelixis Inc. announced a new collaboration with Roche on a phase Ib dose escalation study that will evaluate the safety and tolerability of cabozantinib, Exelixis' tyrosine kinase inhibitor, in combination with atezolizumab, Roche's anti-PD-L1 immunotherapy, in patients with locally advanced or metastatic solid tumors.
Advaxis Inc. granted SELLAS Life Sciences Group a license to develop a novel cancer immunotherapy agent using Advaxis' proprietary Lm-based antigen delivery technology with SELLAS' patented WT1 targeted heteroclitic peptide antigen mixture (galinpepimut-S).
FDA approved the nivolumab (Opdivo) injection for intravenous use for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
