Novartis gains first-line approval for Zykadia in lung cancer

The European Commission has followed the EMA’s CHMP positive opinion by approving Novartis’ Zykadia for first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumours are ALK-positive.

The approval follows a similar decision in the US last month by the FDA. The decision will open up the possibility to treat a proportion of the 3-7% of all patients with NSCLC that are ALK-positive. The approval brings Novartis into direct competition with Pfizer’s Xalkori , which was previously the primary mode of treatment for patients who tested ALK-positive.

The decision was based on the Ascend-4 Phase 3 trial, where the study met its primary endpoint by demonstrating a 45% reduction in the risk of progression compared with the chemotherapy arm. It also found that Zykadia doubled progression-free survival (PFS), as patients that received Zykadia had a median PFS of 16.6 months, against those on chemotherapy with 8.1 months.

"Today's EC approval of Zykadia as a first-line treatment of ALK+ non-small cell lung cancer is an important step forward for patients with this type of serious disease," said Bruno Strigini, CEO, Novartis Oncology. "Our commitment to innovation in lung cancer will continue and we look forward to providing additional advancements for patients as the incidence of the disease grows around the world."

Though the treatment area within the larger NSCLC market is relatively small, Novartis will be happy to get its approval in early. There are a new wave of rival treatments currently moving through the gears, including Takeda’s Alunbrig and Roche’s Alecensa – the latter having already shown superiority against Xalkori in a head-to-head study earlier this year.

Novartis will be hoping to establish its drug quickly, as a first-line therapy, before this wave of new drugs manage to establish themselves as equivalent standards of treatment.