FDA Approves Novartis’ Zykadia for ALK-Positive NSCLC

The FDA has approved Novartis’ lung cancer drug Zykadia four months ahead of its Aug. 24 PDUFA date, the Swiss drug giant said Tuesday.

The drug, an anaplastic lymphoma kinase tyrosine kinase inhibitor, is indicated for patients with metastatic anaplastic lymphoma kinase (ALK) positive non-small-cell lung cancer (NSCLC), who were previously treated with Pfizer’s Xalkori (crizonitib).

Zykadia (ceritinib) also was given orphan drug status along with a breakthrough therapy designation and priority review because of trial results that demonstrated significant improvement over available therapies in safety and efficacy, the FDA said. All 163 patients in a multicenter, single-arm and open-label trial were treated with 750 mg of once-daily Zykadia. Of these, 54.6 percent demonstrated overall responses of 7.4 months of tumor shrinkage.

Zykadia’s clinical development program is ongoing at more than 300 centers in 30 countries. Two Phase II trials are testing previously treated and treatment-naïve ALK-positive NSCLC patients, while two Phase III trials are comparing the drug with chemotherapy in treated and treatment-naïve patients.

Although roughly 85 percent to 90 percent of lung cancer cases around the world are from NSCLC, only between two and seven percent are ALK-positive, a mutation that can fuse with other genes to form a fusion protein that promotes development and growth of cancer, almost guaranteeing disease progression, Novartis says.

The drugmaker says that it has already submitted an application for Zykadia to EU regulators and that filings are in progress in other areas of the world. — Lena Freund

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