The European Medicines Agency has recently released their positive opinion of ALUNBRIG, which is a treatment for anaplastic lymphoma kinase+ (ALK+) non-small cell lung cancer (NSCLC). They have recommended this therapy for those who have not yet been treated with an ALK inhibitor. The EMA has crafted this opinion based off of results of the Phase 3 ALTA-1L trial, a study meant to evaluate the safety and efficacy of ALUNBRIG in comparison to crizotinib. The positive results of this trial not only gave confidence to researchers and participants, but it allowed for a positive reaction from the EMA.
About Non-Small Cell Lung Cancer (NSCLC)
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, and it comes in three different types: adenocarcinomas, squamous cell carcinomas, and large cell carcinomas. The majority of these cancers are caused by smoking cigarettes, but exposure to certain chemicals or materials may also increase the risk of cancer. These substances include arsenic, asbestos, chloride, formaldehyde, certain alloys or pigments, and other chemicals. A history of lung cancer in the family may also heighten one’s chance of developing NSCLC.
The early stages of this cancer see symptoms such as chest pain, coughing to the point of coughing up blood, fatigue, a loss of appetite, shortness of breath, losing weight, and wheezing. Later stages cause pain and tenderness in the bones, drooping eyelids, a hoarse or different voice, joint pain, nail problems, facial swelling, weakness, and trouble swallowing.
A diagnosis is obtained through a physical exam and evaluation of family and medical history. Tests will then be performed to confirm the diagnosis, as well as to assess the spread. These tests include bone scans, chest x-rays, MRIs, CT scans, complete blood counts, PET scans, sputum tests, thoracentesis, and biopsies. Further testing may be necessary to stage the cancer.
Surgery is typically the first step in treatment. The procedure may remove a lobe of the lung, a segment of the lung, or the entire organ. Other forms of treatment include chemotherapy, targeted therapy, laser therapy, photodynamic therapy, and radiation therapy.
ALUNBRIG is a tyrosine kinase inhibitor (TKI) that is intended to find and stop the anaplastic lymphoma kinase genetic mutations, developed by Takeda Pharmaceuticals. This therapy is meant for those who have ALK+ metastatic NSCLC and have not been treated with ALK inhibitors.
It has already been approved in over 40 countries throughout the world, including the U.S. and European Union. The FDA has given it multiple designations, such as the Breakthrough Therapy and Orphan Drug designations.
About the ALTA-1L Trial
The ALTA-1L trial enrolled 275 participants throughout the world in the randomized, double-blind, open-label, comparative, multicenter trial. All participants were required to have ALK+ metastatic or locally advanced non-small cell lung cancer without having received previous treatment of ALK inhibitors. They were given either ALUNBRIG or crizotinib.
The primary endpoint of this study was progression-free survival, with secondary endpoints of objective response rates and overall survival, safety, and tolerability. Results showed that the safety profile remained consistent with the previous findings. They also proved that ALUNBRIG was superior over crizotinib after more than two-years of follow-up. It had a progression free survival of 24 months, compared to crizotinib’s 11 months.
Researchers are excited by the results of this trial, as it addresses an unmet need in the world of healthcare. ALK+ NSCLC is a rare form of lung cancer, resulting in a lower number of treatment options. Takeda hopes that this treatment not only improves the medical world but the lives of patients as well.
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