NEW YORK – Japan-based pharmaceutical company Takeda today announced that the European Commission has approved its selective tyrosine kinase inhibitor brigatinib (Alunbrig) as a monotherapy for patients with ALK-positive, advanced non-small cell lung cancer as a first-line option.
The approval presents another treatment option for patients with ALK rearrangements, who make up three-to-five percent of all patients with metastatic NSCLC.
The approval comes in the wake of positive results from the Phase III ALTA-1L trial, which compared brigatinib to the ALK inhibitor crizotinib (Pfizer's Xalkori) in 275 patients with locally advanced or metastatic ALK-positive NSCLC. Patients in both the brigatinib and crizotinib arms of the trial had not been previously treated with an ALK inhibitor, although slightly over a quarter of the patients in both arms had received chemotherapy first.
"ALK-positive NSCLC is a complex and nuanced disease, and people with this form of lung cancer may benefit from the availability of a variety of treatment options," Stefania Vallone, president of Lung Cancer Europe, said in a statement about the approval. The latest approval applies in all European Union member states as well as Norway, Liechtenstein, and Iceland.
The primary endpoint of the global, multicenter ALTA-1L trial was progression-free survival, for which brigatinib resulted in a median of 24 months versus 11 months with crizotinib, as assessed by a blinded independent review committee (BIRC). Patients with baseline brain metastases also benefitted significantly from brigatinib; after a two-year follow-up, brigatinib had reduced the risk of intracranial disease progression or death by 69 percent, according to the BIRC.
"Patients with ALK-positive NSCLC, particularly those who have developed brain metastases, have been in need of additional treatment options that are proven effective in the first-line setting," Sanjay Popat, a consultant medical oncologist with the Royal Marsden NHS Foundation Trust, said in a statement.
Brigatinib has been approved in 40 countries, including the US, for patients with metastatic ALK-positive NSCLC who don't tolerate crizotinib, or who have progressed on crizotinib. In the US, the FDA has granted Orphan Drug Designation for brigatinib in ROS1-positive and EGFR-positive NSCLC, in addition to ALK-positive NSCLC.