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Home Industry News Novartis receives CHMP backing for Zykadia lung cancer approval

Novartis receives CHMP backing for Zykadia lung cancer approval

23rd May 2017

Novartis has announced that its cancer drug Zykadia has been recommended for European approval in a new lung cancer indication.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended expanding the licence for Zykadia to include the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumours are ALK-positive.

This decision was based on positive findings from the phase III ASCEND-4 study, which showed that first-line Zykadia was associated with a 45 percent reduction in the risk of disease progression compared to standard pemetrexed-platinum chemotherapy.

A final approval decision is expected from the European Commission within two months, with the regulator usually expected to follow the CHMP recommendation.

Bruno Strigini, chief executive officer for Novartis Oncology, said: "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 US Food and Drug Administration granted Zykadia breakthrough therapy designation for the first-line treatment of patients with ALK-positive NSCLC that has metastasised to the brain.

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