The European Commission approved the expanded use of Novartis’ Zykadia® (ceritinib) to include first-line treatment of advanced non-small-cell lung cancer (NSCLC) in patients with anaplastic lymphoma kinase (ALK)-positive tumors.
“Today's EC approval of Zykadia as a first-line treatment of ALK-positive NSCLC is an important step forward for patients with this type of serious disease,” said Bruno Strigini, Pharm.D., CEO, Novartis Oncology. “Our commitment to innovation in lung cancer will continue and we look forward to providing additional advancements for patients as the incidence of the disease grows around the world.”
Last month, the FDA approved the ALK-inhibitor Zykadia as first-line therapy for ALK-positive NSCLC following confirmation by an FDA-approved test. Expanded use of Zykadia as first-line therapy for ALK-positive NSCLC in Europe and in the U.S. was based on data from the Phase III ASCEND-4 study in 376 previously untreated adult patients with stage IIIB or IV ALK-positive advanced NSCLC. Participants received either oral Zykadia therapy with standard pemetrexed-based platinum doublet chemotherapy, followed by pemetrexed maintenance therapy.
The study met its primary endpoint, confirming that treatment using Zykadia was associated with a 45% reduction in the risk of disease progression, compared with chemotherapy. Mean progression-free survival was 16.6 months for Zykadia-treated patients, compared with 8.1 months for patients treated using standard first-line pemetrexed-platinum chemotherapy and pemetrexed maintenance. Among patients with measurable brain metastases at baseline, the overall intracranial response rate (OIRR) was 72.2% for Zykadia-treated patients and 27.3% for chemotherapy patients. For patients without brain metastases at baseline, progression-free survival was 26.3 months, compared with 8.3 months for chemotherapy-treated patients.
Earlier this month the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended EC approval of Novartis’ Kisqali® (ribociclib) combined with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor-2-negative (HR+/HER2–) locally advanced or metastatic breast cancer. FDA approval of Kisqali plus an aromatase inhibitor was granted in March for the same indication.