FDA Approves First-Line Non-Small Cell Lung Cancer Drug

The FDA recently approved a supplemental new drug application for alectinib (Alecensa) as a first-line therapy for anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NCSLC), according to a press release.

The new approval was based on positive results from the phase 3 ALEX clinical trial, which investigated the efficacy of alectinib versus crizotinib.

Included in the trial were 303 patients with ALK-positive NSCLC who had not received treatment for metastatic disease and whose disease was confirmed to be ALK-positive by the VENTANA ALK (D5F3) CDx Assay, according to the release.

The primary efficacy outcome was progression-free survival (PFS) determined by RECIST v1.1. Secondary outcomes included PFS determined by an independent committee, time to central nervous system (CNS) progression, objective response rate, duration of response, and overall survival.

The investigators discovered that treatment with alectinib reduced the risk of progression by 47% compared with crizontinib, according to the release.

The researchers also found that the median PFS was 25.7 months for the alectinib cohort, while it was only 10.4 months for the crizotinib cohort.

Notably, treatment with alectinib lowered the risk of cancer metastasizing to the CNS by 84% compared with crizotinib, according to Genentech.

The safety profile was consistent with previous studies. Genentech said the most common side effects include tiredness, constipation, swelling, and low red blood cell count.

“Our goal is to develop medicines that have the potential to significantly improve upon the standard of care,” said Sandra Horning, MD, chief medical officer and head of Global Product Development, Genentech. “In our pivotal study, Alecensa significantly extended the time that people lived without their disease worsening compared to crizotinib and also showed a marked reduction in the risk of their cancer spreading to the brain.”

Alectinib previously received breakthrough therapy designation for the treatment of patients with ALK-positive NSCLC who have not received previous treatment with an ALK inhibitor.

Additionally, Genentech reported that the FDA converted the drug’s previous accelerated approval for the treatment of people with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib to full approval from a second-line therapy, according to the release.

“ALK-positive lung cancer is often found in younger people, who tend to have more advanced disease at the time of diagnosis, and comes with a unique set of challenges," said Bonnie J. Addario, a lung cancer survivor and founder of the Bonnie J. Addario Lung Cancer Foundation. “We applaud advancements in care, like the approval of Alecensa, which provides a new initial treatment option for people with this type of lung cancer.”