Lung Cancer Drug Receives Second Breakthrough Therapy Designation
FDA grants Roche’s drug Alecensa another Breakthrough Therapy Designation.
Roche’s ALK inhibitor Alecensa (alectinib) recently received a second FDA Breakthrough Therapy Designation for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer who have not received prior treatment with an ALK inhibitor.
This latest Breakthrough Therapy Designation was based on findings from the phase 3 J-ALEX study, which explored the safety of the drug compared with crizotinib.
Included in the study were 207 patients with ALK-positive, advanced or recurrent non-small cell lung cancer, according to a press release from Roche. Patients included had not received prior chemotherapy, or had only 1 line of chemotherapy.
ALK-positive non-small cell lung cancer is typically diagnosed in younger patients with little to no history of smoking.
Findings from the study suggest that Alecensa is able to increase progression-free survival compared with crizotinib. The drug was well tolerated and had a consistent safety profile, according to the press release.
Investigators also found that serious adverse events occurred less frequently among patients taking Alecensa compared with patients taking crizotinib (27% versus 51%, respectively). Common adverse events experienced by patients taking Alecensa were constipation, nausea, diarrhea, vomiting, visual disturbance, alternation in taste, and elevated liver enzymes.
Alecensa received its first FDA Breakthrough Therapy Designation in 2013 for the treatment of patients with ALK-positive non-small cell lung cancer whose disease progressed while being treated with crizotinib, according to Roche.
The drug is currently marketed in the United States and Israel for patients with ALK-positive metastatic non-small cell lung cancer who progressed on, or are intolerant to, crizotinib. In Japan, the drug is indicated in patients with recurrent or advanced non-small cell lung cancer.
Previous studies have found that the drug can shrink tumors in 44% of patients with ALK-positive non-small cell lung cancer who progressed on crizotinib, according to Roche. The drug has also demonstrated positive activity in metastases in the brain, which may indicate that it is able to cross the blood-brain barrier.
There is an ongoing phase 3 clinical trial that compares Alecensa to Xalkori in patients with advanced ALK-positive non-small cell lung cancer, Roche reported.
“The J-ALEX study that supports the second Breakthrough Designation for Alecensa showed superior efficacy versus the standard of care, crizotinib, in Japanese people with advanced ALK-positive disease,” said Sandra Horning, MD, chief medical officer and Head of Global Product Development. “The decision by the FDA to grant a second breakthrough therapy designation is recognition of the clinically meaningful improvement in efficacy and safety that Alecensa brings to the care of people with advanced ALK-positive lung cancer who have not received prior treatment with an ALK inhibitor.”