On Monday, the U.S. Food and Drug Administration (FDA) announced the granting of regular approval to Alecensa (alectinib) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC).
Previously, alectinib had received an FDA breakthrough therapy designation as a frontline treatment for patients with ALK-positive NSCLC.
In December 2015, alectinib received accelerated approval for treatment of patients with ALK-positive metastatic NSCLC whose disease progressed or who were intolerant of crizotinib. In April
, Genentech released data in which Alecensa was reported more effective than Xalkori (crizotinib), anyway. The recent news converts the previous designation into a full approval for the drug.
In the Phase 3 ALEX study (NCT02075840), 303 patients with ALK-positive NSCLC who had not received prior systemic therapy for metastatic disease were enrolled and the drug exhibited an improvement in progression-free survival (PFS), the primary efficacy outcome. It was additionally discovered that treatment with alectinib in this cohort of patients reduced the risk of disease progression by 47%.
Further research is required to evaluate overall survival data, as only a quarter of events have been reported at present.
“Our goal is to develop medicines that have the potential to significantly improve upon the standard of care,” Sandra Horning, MD, chief medical officer and head of Global Product Development, Genentech, said in a news release. “In our pivotal study, Alecensa significantly extended the time that people lived without their disease worsening compared to crizotinib and showed a marked reduction in the risk of their cancer spreading to the brain.”
Serious adverse events (AEs) occurred in 28% of patients treated with alectinib, and included renal impairment, hyperbilirubinemia, increased alanine aminotransferase, and increased aspartate aminotransferase. Common AEs, defined as occurring in ≥20% of patients being treated with alectinib included fatigue, constipation, edema, myalgia, and anemia.
Per the FDA, the recommended dose of alectinib is 600 mg to be taken orally, twice daily with food.
An estimated 75,000 people are diagnosed with ALK-positive NSCLC annually, and the condition primarily affects a patient population with a median age of 52 years old.
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