Novartis’ Zykadia scores priority review and breakthrough designation from FDA

pharmafile | February 23, 2017 | News story | Sales and Marketing Novartis, zykadia 

Novartis’ lung cancer treatment Zykadia (ceritinib) has been awarded both priority review and breakthrough therapy designation by the US Food and Drug Administration (FDA), the company has announced.

Priority review has been given for the drug’s use in patients with metastatic non-small cell lung cancer (NSCLC) whose tumours are anaplastic lymphoma kinase (ALK)-positive, while breakthrough designation was given for the first-line treatment of ALK-positive metastatic NSCLC with metastases in the brain.

In October last year, the drug showed significant benefits over chemotherapy in both progression-free survival and overall response rate, though overall survival remained at the same level. Novartis later claimed that the drug was doubly effective compared to chemo in slowing NSCLC progression.

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The announcement may serve to boost the company’s efforts against rival Alcensa, produced by Roche, who leads the market with sales over $70 million; Zykadia has made sales of around $50 million by comparison.

Matt Fellows

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