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 about $1.6 billion (1.5 billion CHF) in 2023.
Levi GarrawayAlecensa “significantly improves” the standard of care for people with this type of lung cancer, said Genentech CMO and head of global product development Levi Garraway in a Thursday press release.
“The approval of Alecensa marks a pivotal moment for people newly diagnosed with early-stage ALK-positive lung cancer, who until now, were not able to receive ALK-specific therapy,” ALK Positive’s Director of Research and Clinical Affairs Ken Culver said. “These patients, who are typically diagnosed at a younger age, often face recurrence and have a higher risk of developing brain metastases than those with other types of NSCLC.”
Pfizer’s Xalkori was the first to win approval for ALK-positive cancers in 2011, but the field has several competitors now, including drugs from Novartis and Takeda.