FDA Grants Priority Review for Alecensa in Some ALK-Positive NSCLC

The oral ALK inhibitor Alecensa has been granted priority review by the FDA for patients with early-stage ALK-positive NSCLC.

The Food and Drug Administration (FDA) has accepted a supplemental New Drug Application and granted Priority Review to oral ALK inhibitor Alecensa (alectinib) as an adjuvant postsurgical treatment for patients with early-stage ALK-positive non-small cell lung cancer (NSCLC), according to an announcement from Alecensa manufacturer Genentech.

Treatment with Alecensa was shown to result in a 76% reduction in the risk of disease recurrence or death versus treatment with chemotherapy among patients with stage 2 to 3A disease in findings from the phase 3 ALINA trial presented at the 2023 ESMO conference, while two-year disease-free survival (DFS; the time following treatment that a patient lives with no signs or symptoms of disease) was 93.8% and 63%, respectively, and three-year DFS rates were 88.3% and 53.3%.

“Treatment with adjuvant (Alecensa) resulted in a statistically significant and clinically meaningful improvement in DFS compared with chemotherapy,” Dr. Ben Solomon, a medical oncologist at the Peter MacCallum Cancer Centre in Australia, said in a presentation of the data, also stating that “the DFS benefit was seen consistently across subgroups and an (improvement) in (central nervous system)-DFS was observed.”

The FDA previously granted accelerated approval to Alecensa for patients with metastatic ALK-positive NSCLC following progression on Xalkori (crizotinib) in 2015, which followed its 2013 breakthrough therapy designation for patients with ALK-positive NSCLC who had experienced progression on Xalkori. The agency approved Alecensa as a frontline treatment for metastatic ALK-positive NSCLC in 2017, also converting its prior accelerated approval to a full approval at the time.

Regarding the supplemental New Drug Application and Priority Review, the agency is expected to make its decision by May 22, 2023 with Alecensa poised to potentially become the first ALK inhibitor approved for this patient population, according to the announcement. Priority Review designation, according to the agency’s website, “will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications.”

According to the announcement, the application is under review via the agency’s Real-Time Oncology Review pilot program, working to make safe and effective treatments available as quickly as possible.

ALINA launched in August of 2016 and the trial, with the participation of 257 patients, is estimated to be completed in November of 2026, according to its listing on clinicaltrials.gov.

Trial results presented at ESMO also showed that among the intention-to-treat population of patients with stage 1B to 3A disease, two-year DFS rates were 93.6% and 63.7% for those treated with Alecensa and chemotherapy, respectively, while three-year DFS rates were 88.7% and 54%. Incidence of severe or life-threatening side effects was 30% and 31%, respectively, with no deaths due to side effects reported among patients in either cohort. There were 5.5% of patients in the Alecensa arm and 12.5% of patients in the chemotherapy arm who discontinued treatment due to side effects, according to Genentech.

“Adjuvant (Alecensa) was tolerable and in line with the known safety profile of (Alecensa),” Solomon said. “Adjuvant (Alecensa) represents an important new treatment strategy for patients with resected, stage 1B-3A, ALK-positive, NSCLC.”

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