The FDA approval of Alunbrig comes after results from a phase II clinical trial showed positive tumor response rates. The ALTA (ALK in Lung Cancer Trial of AP26113) trial, which is ongoing, is an open-label trial for patients with ALK+ NSCLC, whose cancer had progressed on crizotinib. Alunbrig is continuing to be studied in a phase III trial to assess efficacy and safety in comparison to crizotinib in patients with locally advanced or metastatic ALK+ NSCLC who have not received prior treatment with an ALK inhibitor.2 The most common side effects, occurring in at least 25% of patients, were nausea, diarrhea, fatigue, cough, and headache.1 Full prescribing information for Alunbrig can be found here.
“The rapid development of Alunbrig is a tribute to the dedication of many research scientists and clinicians who carefully designed and developed this new medicine to address unmet medical needs in the ALK+ NSCLC patient population. Most importantly, we would like to thank the patients and families who participated in the clinical trials,” said Andy Plump, M.D., Ph.D., Takeda Chief Medical and Scientific Officer.2
An estimated 3-5% of lung tumors have mutations on the ALK gene, which stands for Anaplastic Lymphoma Kinase. ALK mutations are more common in light smokers (defined as less than 10 pack years*) and/or never-smokers (patients are considered “never smokers” if they have smoked less than 100 cigarettes in their lifetime). These mutations are also associated with younger patient age and adenocarcinomas. In its normal capacity, the ALK gene provides instructions for a protein (anaplastic lymphoma kinase) that plays an important role in cell growth, division, and maturation. Damage to the genes causes normal cells to change and become cancer cells. When there is a mutation to ALK gene, the cancerous cells are activated to grow and multiply.3,4
Alunbrug is a targeted therapy discovered by ARIAD Pharmaceuticals, Inc., which was acquired by Takeda in February 2017.2
Brigatinib. U.S Food and Drug Administration - Approved Drugs. Accessed at: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm555841.htm
Takeda Announces FDA Accelerated Approval of ALUNBRIGTM (brigatinib). April 28, 2017. Takeda - News Release. Accessed at: https://www.takeda.com/newsroom/newsreleases/2017/alunbrig-fda-approval/
My Cancer Genome. Accessed online on 8/14/16 at https://www.mycancergenome.org/.
Genetics Home Reference, National Institutes of Health. Accessed online on 8/2/16 at https://ghr.nlm.nih.gov/.