Roche has been given marketing approval in Japan for alectinib, a drug developed for a specific type of advanced lung cancer.
Japan is the first country to approve alectinib, which has been given a green light to treat non-small cell lung cancer (NSCLC) patients who test positive for the anaplastic lymphoma kinase (ALK) fusion gene.
Approval of alectinib was based on the results of a Japanese phase I/II trial, which indicated that more than 90 per cent of Xalkori-naïve patients treated with the drug responded to treatment, with 83 per cent of them free of progression after 12 months.
“The approval of alectinib, a treatment specifically targeted to ALK-positive lung cancer, in Japan is great news for people living with this difficult to treat disease,” commented Roche’s chief medical officer Sandra Horning.
Roche’s drug targets the same patient population as Pfizer’s rival drug Xalkori (crizotinib), which reached the market as a treatment for ALK-positive NSCLC in the US in 2011 and Europe a year later, pulling in $282m in sales last year.
Xalkori made a dramatic difference to the prospects of patients with ALK-positive NSCLC, who account for around 3 to 5 per cent of the total NSCLC population, but patients eventually develop resistance to the drug after nine to 12 months’ therapy.
Earlier this year, Novartis received approval in the US for its own ALK inhibitor Zykadia (ceritinib; LDK378) for patients who cannot tolerate or have failed treatment with Xalkori. Alectinib ,which is the third drug in the class to be registered, has been granted breakthrough status by the FDA for patients with ALK-positive NSCLC who have progressed on Pfizer’s drug.
Both Zykadia and alectinib have slightly different molecular profiles to Xalkori, raising the hope that they will be effective in non-responders with secondary ALK mutations. They also appear to be particularly active on brain metastases.