FDA approved an expansion to the Imbruvica (ibrutinib) prescribing information based on data supporting its use in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.
Health Canada provided conditional approval of Ibrance (palbociclib) for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer as initial endocrine-based therapy for metastatic disease. The Health Canada approval of Ibrance is based on the final results of the phase II PALOMA-1/TRIO 18 trial (n=165), which studied... […]
The European Commission approved a variation to the terms of the Marketing Authorisation of eribulin for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy for advanced or metastatic disease.
AbbVie and CytomX Therapeutics Inc. entered into a collaboration to co-develop Probody Drug Conjugates against CD71, also known as transferrin receptor 1 (TfR1). Probody therapeutics are designed to take advantage of conditions in the tumor microenvironment to enhance the tumor-targeting features of an antibody and reduce drug activity in healthy tissues. Under the agreement, CytomX... […]
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.
