Roche's Genentech unit has won accelerated FDA approval for Alecensa as a second-line therapy for non-small cell lung cancer (NSCLC).
Alecensa (alectinib) has been approved to treat patients with advanced, ALK-positive NSCLC who have failed prior treatment with Pfizer's Xalkori (crizotinib), which was the first ALK inhibitor to reach the market in 2012.
Accelerated approval gives the FDA leeway to clear early access to a medicine that fills an unmet medical need for a serious condition based on early evidence suggesting clinical benefit.
The FDA's Richard Pazdur, who heads the agency's Office of Hematology and Oncology Products, said: "[Alecensa] provides a new therapy for a group of patients who would have few treatment options once their disease no longer responds to treatment with Xalkori."
Alectinib was originally developed by Chugai - part of the Roche group - and was launched in Japan last year. It is one of three ALK inhibitors on the market alongside Xalkori and Novartis' Zykadia (ceritinib), which was approved for marketing in the US and Europe earlier this year, also as a second-line therapy after Xalkori.
In pivotal trials, Alecensa shrank tumours in up to 44% of people with ALK-positive NSCLC who progressed on Xalkori with a 60% response rate in a subset of people with tumours that spread to the brain or other parts of the central nervous system (CNS).
Lung cancer is the leading cause of cancer death in the US, with an estimated 221,200 new diagnoses and 158,000 deaths this year, according to the National Cancer Institute. NSCLC accounts for around 90% of all lung cancers, and ALK gene mutations are present in about 5% of NSCLC cases.
Alecensa is being studied as a first-line therapy for ALK-positive NSCLC in the phase III ALEX study, which is part of its commitment to convert the current accelerated registration to a full approval.
Analysts have suggested the drug's efficacy profile - particularly its data on progression-free survival - could make it a fierce rival to Xalkori and a potential best-in-class blockbuster.
The new approval caps off a fertile period for NSCLC patients, with Eli Lilly claiming FDA approval for its EGFR-targeting antibody Portrazza (necitumumab) last month, and patients in the UK with T790M-positive tumours getting early access to AstraZeneca's EGFR inhibitor Tagrisso (omisertinib).
Meanwhile, Xalkori has also been granted a priority review for Xalkori as a treatment for patients with ROS1-positive NSCLC, which account for 1% of all NSCLC cases, as well as approval as a first-line NSCLC therapy in Europe.