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EMA's CHMP backs Novartis' Zykadia for first-line use in lung cancer

PBR Staff Writer Published 22 May 2017

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval to expand the use of Novartis' Zykadia (ceritinib) in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

Zykadia, which is to be subjected orally, is a selective inhibitor of the ALK gene. Capable of combining with other genes to form an abnormal fusion protein, the ALK gene boosts the development and growth of certain tumors in cancers like the NSCLC.

Till date, Zykadia has been approved in the European Union (EU) for the treatment of ALK-positive advanced NSCLC in adult patients who were previously treated with crizotinib.

Novartis Oncology CEO Bruno Strigini said: "Novartis is committed to bringing targeted treatment options to more patients living with lung cancer who may benefit from them.

"Today, we've taken an important step towards fulfilling that commitment with the potential approval of Zykadia as a first-line treatment option for those in the EU diagnosed with ALK-positive advanced NSCLC."

The positive opinion from CHMP opinion was driven by the results of a randomized, open-label, phase 3 study dubbed as ASCEND-4 study held at multiple centres across the world.

The trial featured 376 adult patients having Stage IIIB or IV ALK-positive advanced NSCLC who did not receive any prior therapy for their advanced disease.

The late stage trial demonstrated that Zykadia-treated patients had a 45% reduction in the risk of disease progression compared to those treated with standard pemetrexed-platinum chemotherapy with pemetrexed maintenance. Both the patient groups were subjected to first-line treatments.

The median progression-free survival (PFS) in the Zykadia arm was 16.6 months compared to 8.1 months recorded in the chemotherapy arm.

If approved, Zykadia will go on to become a new treatment option for previously untreated and newly diagnosed patients having ALK-positive advanced NSCLC.


Image: Novartis headquarters in Basel, Switzerland. Photo: courtesy of Novartis AG.