The European Commission has expanded the scope of Novartis’ Zykadia to include the first line treatment of patients with non-small cell lung cancer (NSCLC) whose tumours are anaplastic lymphoma kinase (ALK)-positive.
The drug was originally cleared in the region in 2015 to treat patients with ALK+ metastatic non-small cell lung cancer who have progressed on or are intolerant to Pfizer's Xalkori (crizotinib).
Its wider approval comes on the back of data from the Phase III ASCEND-4 trial, which showed a 45 percent reduction in the risk of disease progression patients taking Zykadia verus those taking chemotherapy.
Those treated with first-line Zykadia had a median progression-free survival (PFS) of 16.6 months compared to 8.1 months for patients treated with standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance.
The drug also showed a benefit in patients with brain metastases with a median PFS of 10.7 months compared to 6.7 months in the chemotherapy arm.
Around 3-7 percent of all patients with NSCLC have an ALK gene rearrangement.