The drug, approved in Japan last year, had been granted Breakthrough Therapy designation by the FDA.
Roche has announced that an oral anaplastic lymphoma kinase (ALK) inhibitor developed by the company has been granted priority review by the US regulatory authority. The company filed a New Drug Application for alectinib (Alecensa) within 2 years of being granted a Breakthrough Therapy designation for the treatment of patients with ALK-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed or are intolerant to crizotinib.
Alectinib was approved in Japan last year for the treatment of ALK-positive NSCLC patients, based on the results of a phase 1/2 study that included individuals whose tumors had advanced, were recurrent, or were unresectable. The 90% response rate in the Japanese population may have been responsible for the drug being approved based on the early phase results.
The NDA filed with the FDA provides results of 2 phase 2 studies. One was a single-arm, open-label, multicenter trial (NP28761) evaluating the safety and efficacy of alectinib in 87 people with ALK-positive NSCLC whose disease progressed on crizotinib. Nearly 50% of trial participants saw their tumor shrink. Those with metastases to the brain or other regions of the central nervous system (CNS) also saw their cancer respond to alectinib, indicating that the drug crosses the blood-brain-barrier, a lipid-rich region which is usually difficult to penetrate. The duration of primary tumor response was sustained for a median period of 7.5 months. Most common grade 3 or greater adverse events in the trial were dyspnea and increased levels of muscle and liver enzymes.
A second trial (NP28673) evaluated the safety and efficacy of alectinib in 138 individuals with a similar profile as in NP28761. Using RECIST criteria, a 50% response rate was observed with respect to tumor shrinkage in this population. While the median duration of response was longer in this group (11.2 months), a CNS response in those with brain and other CNS metastases was observed. Dyspnea was the most common grade 3 or higher adverse event observed in NP28673.
Sales discussions around the drug began immediately following approval in Japan, with experts predicting a blockbuster status for alectinib—analysts at Cowen and Company project the drug could bring in annual sales of $1 billion by 2020.
The decision date for alectinib for US approval is set for March 4, 2016.