EMA Adopts a New Indication for Ceritinib

It is now also indicated for the first-line treatment of ALK-positive advanced NSCLC
22 May 2017

On 18 May 2017, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product ceritinib (Zykadia).

The marketing authorisation holder for this medicinal product is Novartis Europharm Ltd.

The CHMP adopted a new indication as follows:

"Zykadia as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)."

For information, the full indications for Zykadia will be as follows:

"Zykadia as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Zykadia as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib."

In addition, since all specific obligations of the conditional marketing authorisation have been fulfilled, the marketing authorisation for Zykadia will be switched from conditional to full approval.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

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Last update: 22 May 2017

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