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Novartis drug Zykadia granted FDA Priority Review.

M2 EQUITYBITES-February 24, 2017-Novartis drug Zykadia granted FDA Priority Review

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Novartis has announced that its supplemental New Drug Application (sNDA) has been accepted for filing by the FDA, and that it has received Priority Review for the expanded use of Zykadia (ceritinib) as a first-line treatment for patients with ALK+ metastatic NSCLC, World Pharma News reported on Friday.

The FDA has granted Priority Review approval for the expanded use of Zykadia as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC), whose tumours are anaplastic lymphoma kinase (ALK)-positive when detected by an FDA-approved test.

Breakthrough Therapy designation has also been granted to Zykadia by the FDA, for the first-line treatment of patients with ALK+ metastatic NSCLC with metastases to the brain.

The sNDA submission for first-line use of Zykadia is based on initial analysis of the results from ASCEND-$, a global Phase III randomised, multi-centre clinical trial to evaluate the drug's safety and efficiency compared with platinum-based chemotherapy.

In a statement, Vas Narasimhan - global head drug development and chief medical officer at Novartis - said the company is "committed to advancing our understanding of mutation-driven lung cancer, where there continues to be significant unmet need."

"Today's Priority Review of Zykadia for newly diagnosed patients with ALK+ metastatic NSCLC, including Breakthrough Therapy designation for those with brain metastases, brings us closer to delivering the right treatment to the right patient at the right time," he added.

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Date:Feb 24, 2017
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