AstraZeneca and Foundation Medicine Inc. will collaborate to develop companion diagnostic assays to identify patients most likely to benefit from medicines within AstraZeneca’s oncology pipeline. AstraZeneca will utilize the Quality Systems Regulations-compliant version of Foundation Medicine’s comprehensive genomic profiling assay for solid tumors to enroll patients into clinical trials of therapies that target genomically driven... […]
The European Medicines Agency Committee for Medicinal Products for Human Use issued a positive opinion for Imbruvica (ibrutinib) for the treatment of adult patients with previously-untreated chronic lymphocytic leukemia. The positive CHMP recommendation follows the March 2016 FDA approval of Imbruvica for the first-line treatment of patients with CLL. If approved by the European Commission,... […]
Health Canada approved Lynparza (olaparib) capsules as a maintenance treatment for patients with platinum-sensitive relapsed BRCA-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer. Lynparza is the first poly ADP-ribose polymerase inhibitor available in Canada, and has been granted the Health Canada Notice of Compliance with Conditions, based on... […]
FDA granted accelerated approval to Venclexta tablets (venetoclax) for patients diagnosed with chronic lymphocytic leukemia with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.
FDA granted Orphan Drug Designation to VAL-083 in the treatment of ovarian cancer. The investigational drug candidate, developed by DelMar Pharmaceuticals Inc., previously received an orphan designation for glioma and medulloblastoma in the United States and glioma in Europe. In more than 40 phase I and II clinical studies sponsored by NCI, VAL-083 demonstrated clinical […]
FDA approved Cabometyx (cabozantinib) tablets for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.
FDA approved Gilotrif (afatinib) tablets for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.
The University of Chicago and AbbVie entered into a five-year collaboration in oncology. Initially, both organizations will work together to advance research in several areas of oncology, which could include, among others, breast, lung, prostate, colorectal and hematological cancer. Research projects are chosen by a joint steering committee, comprised of representatives from each organization. AbbVie... […]
FDA granted accelerated approval to Venclexta tablets (venetoclax) for patients diagnosed with chronic lymphocytic leukemia with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.
FDA granted priority review for atezolizumab (MPDL3280A) for the treatment of people with locally advanced or metastatic non-small cell lung cancer whose disease expresses the protein PD-L1, as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy. “In a study of atezolizumab in people with previously treated advanced lung cancer,... […]
