Genentech Wins FDA Approval for First Adjuvant Therapy for ALK-Positive, Early NSCLC

Published: Apr 19, 2024 By Tristan Manalac

Genentech_iStock, Sundry Photography

Pictured: Genentech’s sign at its headquarters in California/iStock, Sundry Photography

The FDA on Thursday greenlit the use of Genentech’s Alecensa (alectinib) for the adjuvant treatment of patients with early-stage, anaplastic lymphoma kinase-positive non-small cell lung cancer who have undergone tumor resection.

With the approval, Alecensa is now the “first and only” ALK inhibitor approved for this indication and patient population, according to Genentech.

Thursday’s regulatory win is backed by data from the Phase III ALINA trial, a randomized, active-controlled and open-label study comparing adjuvant Alecensa with platinum-based chemotherapy. The study enrolled 257 patients with Stage IB to IIIA tumors who had undergone resection and tested positive for anaplastic lymphoma kinase (ALK) using an FDA-approved test.

Results from ALINA, which the company released in October 2023, showed that…
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