Roche group Genentech says its application to expand the use of Alecensa to include first-line treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) has been approved by US regulators.
The decision rides on the back of data from the Phase III ALEX study, which showed the drug significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 47 percent compared to crizotinib.
Median PFS was found to be 25.7 months for people who received Alecensa (alectinib) compared with 10.4 months for those taking crizotinib, according to the data.
The study also showed that the drug significantly cut the risk of the cancer spreading to or growing in the brain or central nervous system compared to crizotinib by 84 percent.
The US FDA also converted Alecensa's initial accelerated approval in December 2015 for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib to a full approval.
European regulators are yet to rule on the drug’s use in the first-line setting, but the Committee for Medicinal Products for Human use has recommended its approval, and patients in the UK are already getting access following its inclusion in the country’s Early Access to Medicines Scheme.
Alecensa is also already approved for use within the European Union to treat adults with ALK positive NSCLC who have previously been treated with crizotinib.
Roche has previously noted that most patients with ALK-positive NSCLC develop resistance to the current standard of care within one year of treatment, and around 60 percent will develop metastases in the central nervous system, highlighting the need for new treatment options.