Paid

Drugs & Targets

FDA approves Vectibix for use in wild-type ras metastatic colorectal cancer

FDA approved the supplemental Biologics License Application for Vectibix (panitumumab) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.
Drugs & Targets

Novartis Kisqali receives positive CHMP opinion for HR+/HER2- locally advanced or metastatic breast cancer

Novartis said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Kisqali (ribociclib) in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative locally advanced or metastatic breast cancer as initial endocrine-based therapy.
In Brief

Gideon Blumenthal named acting deputy director of FDA Office of Hematology & Oncology Products

Gideon Blumenthal has been appointed acting deputy office director of the Office of Hematology and Oncology Products at FDA. Blumenthal is a medical oncologist and serves as the associate director of precision therapeutics in OHOP. The appointment was announced by Richard Pazdur, director of the Oncology Center of Excellence and OHOP acting director. Blumenthal previously... […]