FDA approves Novartis’ Zykadia as first-line lung cancer treatment
pharmafile | May 30, 2017 | News story | Manufacturing and Production, Sales and Marketing |Â Â FDA, NSCLC, NovartisÂ
The FDA has announced it has approved Novartis’ Zykadia (ceritinib) as a first line treatment in the expanded indication of metastatic non-small cell lung cancer (NSCLC) in patients with anaplastic lymphoma kinase (ALK)-positive tumours.
The decision to approve the treatment stemmed from 376-participant Phase 3 trial results which showed that Zykadia produced a median progression-free survival rate of 16.6 months, more than double the 8.1 months achieved by standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance. Overall intracranial response rate was 57% in patients with measurable brain metastases, while chemotherapy only produced a rate of 22%.
“Today’s approval represents the next step in the development of Zykadia as a treatment option for ALK-positive metastatic NSCLC, bringing this important medication to a patient population where a need still exists,” remarked ,” said Bruno Strigini, CEO of Novartis Oncology. “At Novartis, we are tireless in our pursuit of developing novel medicines to treat lung cancer, and the first-line approval of Zykadia for ALK-positive metastatic NSCLC illustrates our commitment to cancer patients.”
The drug was given priority review by the FDA earlier this year for the expanded indication, and was originally awarded accelerated approval for ALK-positive metastatic NSCLC in 2014 for patients already treated with Pfizer’s Xalkori (crizotinib).
Matt Fellows
Related Content
Novartis receives SMC approval for early breast cancer treatment
Novartis has announced that its treatment for early breast cancer, Kisqali (ribociclib), has received approval …
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
