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FDA grants breakthrough therapy designation to Alecensa for first-line treatment of ALK–positive NSCLC
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The FDA granted a new breakthrough therapy designation to alectinib for the treatment of adults with advanced ALK–positive non–small cell lung cancer who have not received prior treatment with an ALK inhibitor, according to the drug’s manufacturer.
The open-label, phase 3 J-ALEX study included 207 previously untreated patients with ALK–positive, advanced or recurrent NSCLC who were randomly assigned to receive alectinib (Alecensa, Genentech) or crizotinib (Xalkori, Pfizer).
Patients who received alectinib demonstrated a 66% reduced risk for disease progression or death compared with those treated with crizotinib (HR = 0.34, 95% CI, 0.17-0.7).
Median PFS was not reached in the alectinib arm, whereas patients in the crizotinib arm demonstrated a median PFS of 10.2 months (95% CI, 8.2-12).
Grade 3 to grade 4 adverse events occurred more frequently with crizotinib than alectinib (51% vs. 27%).
The most common adverse events in the alectinib arm included nausea (74%), diarrhea (73%), vomiting (59%), visual disturbance (55%), dysgeusia (52%), constipation (46%), and an elevation in alanine transaminase (32%) and aspartate transaminase (31%).
The FDA previously granted breakthrough therapy designation and accelerated approval to alectinib for the treatment of patients with ALK–positive NSCLC whose disease progressed on or after treatment with crizotinib.
“The decision by the FDA to grant a second breakthrough therapy designation is recognition of the clinically meaningful improvement in efficacy and safety that alectinib brings to the care of people with advanced ALK–positive lung cancer who have not received prior treatment with an ALK inhibitor,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a press release.