Non-small cell lung cancer (NSCLC) patients have a new treatment available following the US Food & Drug Administration's (FDA's) approval of Alunbrig (brigatinib). The Takeda Pharmaceuticals medication received Accelerated Approval for treatment of patients with anapestic lymphoma kinase-positive (ALK+) NSCLC who progressed on or are intolerant to Xalkori (crizotinib).
Bonnie Addario, founder and chair of the Addario Lung Cancer Foundation (ALCF), welcomed the FDA's decision, commenting: "For patients with ALK+ metastatic NSCLC who have progressed on or are intolerant to crizotinib, who are facing the uncertainty of disease progression and the potentially devastating impact of brain metastases, the approval of Alunbrig offers a new hope." Her comments echoed those of Christophe Bianchi, MD, president of Takeda Oncology, who described the FDA's approval of the drug as an "important milestone".
Lung cancer claims the lives of more Americans than any other form of cancer, according to figures from the Centers for Disease Control and Prevention. More than 200,000 people in the US are diagnosed with the condition each year, with 150,000 deaths attributed to lung cancer annually. NSCLC is the most common form of lung cancer, accounting for around 85 percent of the new cases of lung cancer diagnosed each year.
The importance of the approval was highlighted by D. Ross Camidge, MD, PhD, director of thoracic oncology at the University of Colorado, who explained: "There is still a need for additional ALK inhibitors like Alunbrig (brigatinib), which have a manageable safety profile and may address mechanisms of clinical resistance to crizotinib, including progression in the central nervous system."
Alunbrig (brigatinib) is a kinase inhibitor, a class of drugs used to treat a number of different forms of cancer, including leukemia, breast cancer, melanoma and renal cancer. It received FDA approval for treating adults with NSCLC following a Phase 2 ALK in Lung Cancer Trial of AP26113 (ALTA) involving 222 patients with locally advanced or metastatic ALK+ NSCLC who progressed on crizotinib.
The study showed more than half (54 percent) of the patients given Alunbrig (brigatinib) during the trial achieved a confirmed overall response to the medication. The drug is administered once daily as a second line therapy for adults with NSCLC who carry the ALK mutation. Around five percent of patients with the condition carry this mutation.
Takeda Pharmaceuticals is not the only company to make progress with lung cancer medication in recent weeks. Earlier this month, AstraZeneca and MedImmune announced "highly encouraging" results in a Phase III PACIFIC trial of Imfinzi (durvalumab) as a sequential treatment for patients with NSCLC. The drug is now being tested as a first-line monotherapy treatment for NSCLC patients.
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