FDA News

FDA approves Alecensa for ALK-positive metastatic non-small cell lung cancer

The FDA approved alectinib for the first-line treatment of patients with ALK-positive metastatic non-small cell lung cancer, as detected by an FDA-approved test.

The agency’s decision included data from the open-label, randomized, active-controlled, multicenter phase 3 ALEX study — designed to evaluate the efficacy and safety of alectinib (Alecensa; Genentech/Roche), a kinase inhibitor, in 303 patients with ALK-positive NSCLC who had not received prior systemic therapy for metastatic disease.

The researchers characterized patients as ALK-positive using the VENTANA ALK (D5F3) CDx Assay (Roche Tissue Diagnostics).

Researchers randomly assigned patients 1:1 to receive either alectinib or crizotinib (Xalkori, Pfizer).

Investigator-assessed PFS served as the primary endpoint. Secondary endpoints included independent review committee PFS, time to progression, objective response rate, duration of response and OS.

Patients treated with alectinib experienced a 47% reduction in risk for disease worsening or death (HR = 0.53; 95% CI, 0.38-0.73) and longer median PFS as assessed by an independent review committee (25.7 months vs. 10.4 months).

In addition, treatment with alectinib reduced the risk for progression in the central nervous system by 84% (HR = 0.16; 95% CI, 0.1-0.28), and fewer patients assigned alectinib experienced 12-month CNS progression (9.4% vs. 41.4%).

“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 at Roche, said in company-issued release. “In our pivotal study, Alecensa significantly extended the time that people lived without their disease worsening compared with crizotinib and also showed a marked reduction in the risk for their cancer spreading to the brain.”

The safety profile appeared consistent with those previously seen. The most common grade 3 to 4 adverse events included increased creatinine (4.1%), hyperbilirubinemia (5%), hyponatremia (6%), aspartate transaminase (6%), alanine transaminase (6%) and anemia (7%).

In addition, the FDA also converted to full approval the agent’s initial accelerated approval, made in December 2015, for the treatment of patients with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib.

The FDA approved alectinib for the first-line treatment of patients with ALK-positive metastatic non-small cell lung cancer, as detected by an FDA-approved test.

The agency’s decision included data from the open-label, randomized, active-controlled, multicenter phase 3 ALEX study — designed to evaluate the efficacy and safety of alectinib (Alecensa; Genentech/Roche), a kinase inhibitor, in 303 patients with ALK-positive NSCLC who had not received prior systemic therapy for metastatic disease.

The researchers characterized patients as ALK-positive using the VENTANA ALK (D5F3) CDx Assay (Roche Tissue Diagnostics).

Researchers randomly assigned patients 1:1 to receive either alectinib or crizotinib (Xalkori, Pfizer).

Investigator-assessed PFS served as the primary endpoint. Secondary endpoints included independent review committee PFS, time to progression, objective response rate, duration of response and OS.

Patients treated with alectinib experienced a 47% reduction in risk for disease worsening or death (HR = 0.53; 95% CI, 0.38-0.73) and longer median PFS as assessed by an independent review committee (25.7 months vs. 10.4 months).

In addition, treatment with alectinib reduced the risk for progression in the central nervous system by 84% (HR = 0.16; 95% CI, 0.1-0.28), and fewer patients assigned alectinib experienced 12-month CNS progression (9.4% vs. 41.4%).

“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 at Roche, said in company-issued release. “In our pivotal study, Alecensa significantly extended the time that people lived without their disease worsening compared with crizotinib and also showed a marked reduction in the risk for their cancer spreading to the brain.”

The safety profile appeared consistent with those previously seen. The most common grade 3 to 4 adverse events included increased creatinine (4.1%), hyperbilirubinemia (5%), hyponatremia (6%), aspartate transaminase (6%), alanine transaminase (6%) and anemia (7%).

In addition, the FDA also converted to full approval the agent’s initial accelerated approval, made in December 2015, for the treatment of patients with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib.