Results from a pre-specified interim analysis from the phase III J-ALEX study found that Alecensa (alectinib) reduced the risk of disease worsening or death by 66 percent compared to (Xalkori) crizotinib in Japanese people with advanced or recurrent ALK-positive non-small cell lung cancer (HR=0.34, 99% CI: 0.17-0.70, p<0.0001) who had not received prior treatment with an ALK inhibitor.
FDA has accepted a New Drug Application for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act target action date is Feb. 27, 2027.
