Roche’s Genentech touts label expansion for blockbuster lung cancer drug Alecensa

Roche’s Genentech said that Alecensa scored a label expansion from the FDA, with the drug now approved as an adjuvant treatment following tumor resection in patients with ALK-positive non-small cell lung cancer.

The approval is based on data from the Phase 3 ALINA study that showed Alecensa reduced the risk of disease recurrence or death by 76% compared to those in the control arm who received chemotherapy following surgery.

Additional data shared at ESMO last year showed that at 24 months, Alecensa’s disease-free survival was 93.6% versus chemo’s 63.7%. One year later, Roche’s drug hit 88.7% versus 64% with chemo.

The drug is already approved for first-line metastatic disease and those who have progressed from Pfizer’s Xalkori. It’s also one of Roche’s 20 top-selling drugs, bringing in…
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