Roche’s Alecensa approved by FDA as lung cancer treatment

Betsy Goodfellow | April 19, 2024 | News story | Medical Communications FDA, Oncology, Roche, lung cancer 

Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) for the adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

Alecensa is now the first and only FDA-approved ALK inhibitor approved for patients with ALK-positive early-stage NSCLC who have already undergone surgery to remove the tumour.

The approval follows positive results from the phase 3 ALINA study which demonstrated that Alecensa reduced the risk of disease recurrence or death by 76% compared to platinum-based chemotherapy in people with completely secected IB to IIIA ALK-positive NSCLC.

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Levi Garrway MD PhD, Roche’s chief medical officer and head of global product development, commented: “With an unprecedented 76% reduction in the risk of disease recurrence or death versus chemotherapy, Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer. At Roche, our goal is to give patients the best chance of cure by bringing effective, targeted treatments to early-stage disease before their cancer has spread. This approval brings us one step closer to achieving that mission.”

Betsy Goodfellow

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