August 9, 2017 - Episode 1

FDA Approval in AML, Priority Review Designation in NSCLC, and More


An FDA approval in acute myeloid leukemia, a priority review designation in non—small cell lung cancer, and exclusive sit-down interviews with Drs Tanios Bekaii-Saab and Geoffrey Oxnard.

Welcome to OncLive News Network! I’m Gina Columbus.

The FDA has approved CPX-351 for adult patients with newly diagnosed therapy-related acute myeloid leukemia or AML with myelodysplasia-related changes.

The approval for CPX-351, which is a fixed-combination of daunorubicin and cytarabine, comes several months ahead of the FDA deadline. It was based on an improvement in overall survival in a phase III study comparing CPX-351 with traditional cytarabine and daunorubicin, known as 7+3, for patients with newly diagnosed t-AML or AML-MRC.

Results showed that the median OS was 9.56 months with CPX-351 versus 5.95 months with 7+3, representing a 31% reduction in the risk of death.

Additionally, the complete response or CR with incomplete platelet or neutrophil recovery rate was 47.7% versus 33.3% for CPX-351 and 7+3, respectively. For CR alone, the rates were 37.3% for CPX-351 and 25.6% for 7+3.

At 12 months, the OS rate was 41.5% in the CPX-351 arm versus 27.6% in the 7+3 group. At 24 months, 31.1% of patients enrolled in the CPX-351 arm of the study remained alive compared with 12.3% with 7+3. The median event-free survival was 2.53 months with CPX-351 versus 1.31 months with 7+3.

CPX-351 was approved with a boxed warning advising against interchanging the medication with other daunorubicin- and/or cytarabine-containing products. The FDA also advised against using CPX-351 in patients with a history of serious hypersensitivity to daunorubicin, cytarabine, or any component of the formulation.


In non—small cell lung cancer, the FDA has granted a priority review to a supplemental new drug application for alectinib for the frontline treatment of patients with ALK-positive locally advanced or metastatic disease.

The agency is scheduled to issue a final ruling by November 30, 2017. Alectinib was previously approved for patients with metastatic ALK-positive NSCLC who have progressed on or are intolerant to crizotinib.

The frontline application is based on results from the phase III ALEX and J-ALEX studies. When compared with crizotinib, alectinib improved progression-free survival by 53% in the ALEX study and by 62% in the J-ALEX trial.

Alectinib was also found to reduce the risk for progression in the central nervous system by 84% versus crizotinib in the ALEX trial. The 12-month cumulative rate of CNS progression for patients with or without existing CNS metastases at baseline was 9.4% in the alectinib arm and 41.4% for crizotinib.


This week, we sat down with Dr Tanios Bekaii-Saab of Mayo Clinic to share his insight on the recent FDA accelerated approval of nivolumab for the treatment of adult and pediatric patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.


We also met up with Dr Geoffrey Oxnard of Dana-Farber Cancer Institute, who discussed his views on the utility of liquid biopsies in the field of lung cancer.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.