This article has been corrected to state that Roche filed a supplemental new drug application (sNDA), not a supplemental biologics application (sBLA).
NEW YORK – Roche on Monday said the US Food and Drug Administration has accepted its supplemental new drug application (sNDA) seeking approval for the ALK inhibitor Alecensa (alectinib) as adjuvant therapy for early-stage ALK-positive non-small cell lung cancer.
In its application, Roche has submitted data from the Phase III ALINA trial, in which Alecensa reduced the risk of disease recurrence or death by 76 percent in the adjuvant setting compared with chemotherapy. Alecensa is currently approved as a first-line treatment for ALK-positive metastatic NSCLC.
Roche noted that if approved, Alecensa would be the first and only ALK inhibitor for early-stage, ALK-positive NSCLC. In the lung cancer space, however, precision medicines are moving into earlier lines of treatment. Roche, in 2021, achieved FDA approval for its checkpoint inhibitor Tecentriq (atezolizumab) as an adjuvant treatment for certain NSCLC patients with PD-L1-expressing tumors. And the year before that, the agency approved AstraZeneca's EGFR inhibitor Tagrisso (osimertinib) in the adjuvant setting for EGFR-mutated NSCLC.
In the ALINA trial, researchers compared the activity of Alecensa with platinum-based chemotherapy in 257 patients with resected stage IB to IIIA ALK-positive NSCLC. The primary endpoint of the trial is disease-free survival, and secondarily, investigators are tracking overall survival, pharmacokinetics, and adverse events. The company reported in October that the two-year, disease-free survival rate was 94 percent in the Alecensa arm and 64 percent in the chemo arm. At three years, 89 percent of patients on Alecensa had no disease recurrence compared with 54 percent of those on chemo.
The FDA has granted Roche's sNDA priority review and is assessing it under its Real-Time Oncology Review pilot program, which aims to speed promising treatments to patients through a more efficient review process. The FDA is expected to decide whether to approve Alecensa for adjuvant NSCLC treatment by May 22.