Roche’s Alecesna has been cleared for use in Europe as a first-line treatment for ALK-positive non-small cell lung cancer (NSCLC), offering a new option for patients newly diagnosed with the disease.
The approval is based on data from the Phase III ALEX study, which showed that the drug significantly cut the risk of disease worsening or death by 53 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 findings also showed that Alecensa slashed the risk of tumours spreading to, or growing in the brain or central nervous system (CNS) compared to crizotinib by 84 percent. Around 60 percent of patients will develop metastases in the central nervous system.
Noting that many ALK-positive lung cancer patients see their disease progress within a year of treatment, said Sandra Horning, MD, Roche’s chief medical officer and head of Global Product Development said EU approval of Alecensa “heralds a new era for these patients, who now have a treatment option available that halves the risk of disease progression compared with the previous standard of care, crizotinib and is also highly effective against brain metastases.”
The European Commission also converted the Alecensa’s existing conditional approval for use when prior treatment with crizotinib has failed to a standard one.