FDA News

FDA grants priority review to Alecensa for ALK-positive non-small cell lung cancer

The FDA granted priority review to alectinib for the first-line treatment of patients with ALK-positive, locally advanced or metastatic non-small cell lung cancer, according to the drug’s manufacturer.

The supplemental new drug application included results from the phase 3 ALEX and J-ALEX studies, designed to evaluate alectinib (Alecensa, Genentech/Roche) — a kinase inhibitor — as first-line treatment for patients with ALK-positive, locally advanced or metastatic NSCLC as detected by an FDA-approved test.

“Phase 3 results showed Alecensa reduced the risk of disease worsening by more than half compared to the current standard of care and lowered the risk of tumors spreading to or growing in the brain by more than 80%,” Sandra Horning, MD, chief medical officer and head of global product development, said in a company-issued release. “We are working closely with the FDA to bring this medicine as an initial treatment for people with ALK-positive NSCLC as soon as possible.”

The randomized, multicenter, open-label ALEX trial evaluated the efficacy and safety of alectinib compared with crizotinib (Xalkori, Pfizer) in 303 treatment-naive patients with ALK-positive NSCLC whose tumors were characterized by the VENTANA ALK (D5F3) CDx Assay (Roche Tissue Diagnostics).

Patients treated with alectinib experienced a reduced risk for disease worsening or death (HR = 0.47; 95% CI, 0.34-0.65) and longer median PFS as assessed by an independent review committee (25.7 months vs. 10.4 months; HR = 0.5; 95% CI, 0.36-0.7) than patients treated with crizotinib.

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 led to a lower 12-month cumulative rate of CNS progression (9.4% vs. 41.4%).

The most common serious adverse events included increased alanine transferase and aspartate transferase and anemia.

The open-label, randomized J-ALEX trial compared the efficacy and safety of alectinib with crizotinib in 207 Japanese patients with ALK-positive, advanced or recurrent NSCLC who had not been treated with an ALK inhibitor.

In that trial, alectinib reduced risk for disease worsening or death (HR = 0.38; 95% CI, 0.26-0.55), and led to longer median PFS (25.9 months vs. 10.2 months).

Further, treatment with alectinib reduced the risk for CNS progression by 81% in patients without baseline metastases (HR = 0.19; 95% CI, 0.07-0.53) and by 49% in patients with brain metastases (HR = 0.51; 95% CI, 0.16-1.64).

The most common serious adverse events included blood creatine phosphokinase increase and interstitial lung disease.

The FDA set an action date for Nov. 30.

The FDA granted priority review to alectinib for the first-line treatment of patients with ALK-positive, locally advanced or metastatic non-small cell lung cancer, according to the drug’s manufacturer.

The supplemental new drug application included results from the phase 3 ALEX and J-ALEX studies, designed to evaluate alectinib (Alecensa, Genentech/Roche) — a kinase inhibitor — as first-line treatment for patients with ALK-positive, locally advanced or metastatic NSCLC as detected by an FDA-approved test.

“Phase 3 results showed Alecensa reduced the risk of disease worsening by more than half compared to the current standard of care and lowered the risk of tumors spreading to or growing in the brain by more than 80%,” Sandra Horning, MD, chief medical officer and head of global product development, said in a company-issued release. “We are working closely with the FDA to bring this medicine as an initial treatment for people with ALK-positive NSCLC as soon as possible.”

The randomized, multicenter, open-label ALEX trial evaluated the efficacy and safety of alectinib compared with crizotinib (Xalkori, Pfizer) in 303 treatment-naive patients with ALK-positive NSCLC whose tumors were characterized by the VENTANA ALK (D5F3) CDx Assay (Roche Tissue Diagnostics).

Patients treated with alectinib experienced a reduced risk for disease worsening or death (HR = 0.47; 95% CI, 0.34-0.65) and longer median PFS as assessed by an independent review committee (25.7 months vs. 10.4 months; HR = 0.5; 95% CI, 0.36-0.7) than patients treated with crizotinib.

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 led to a lower 12-month cumulative rate of CNS progression (9.4% vs. 41.4%).

The most common serious adverse events included increased alanine transferase and aspartate transferase and anemia.

The open-label, randomized J-ALEX trial compared the efficacy and safety of alectinib with crizotinib in 207 Japanese patients with ALK-positive, advanced or recurrent NSCLC who had not been treated with an ALK inhibitor.

In that trial, alectinib reduced risk for disease worsening or death (HR = 0.38; 95% CI, 0.26-0.55), and led to longer median PFS (25.9 months vs. 10.2 months).

Further, treatment with alectinib reduced the risk for CNS progression by 81% in patients without baseline metastases (HR = 0.19; 95% CI, 0.07-0.53) and by 49% in patients with brain metastases (HR = 0.51; 95% CI, 0.16-1.64).

The most common serious adverse events included blood creatine phosphokinase increase and interstitial lung disease.

The FDA set an action date for Nov. 30.