US regulators will undertake a speedy review of Roche group Genentech’s alectinib as a treatment for certain forms of lung cancer.
The US Food and Drug Administration will consider the drug’s use for people with ALK-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Pfizer's Xalkori (crizotinib).
The priority review, which speeds up the assessment time to within six months, is based on results from two Phase II studies showing that alectinib shrank tumours in this patient group.
The NP28761 trial showed an objective response rate of 47.8% in patients taking the drug and a median response of 7.5 months, while the NP28673 study showed an ORR of 50% and a median response of 11.2 months.
Sandra Horning, chief medical officer and head of Global Product Development at Genentech, said new treatments options are urgently needed, “especially because the disease often spreads to the brain at progression”.
Alectinib was awarded ‘breakthrough’ status in the US in 2013.