Genentech oncology treatment granted first-of-a-kind approval

The first adjuvant treatment for tumour-resected early-stage anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) has been approved by the US Food and Drug Administration (FDA). This authorisation was granted to Genentech’s (a member of the Roche Group) small molecule treatment Alecensa ^® (alectinib).

“Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer,” summarised Dr Levi Garraway, Chief Medical Officer and Head of Global Product Development, Roche.

According to Genentech, Alecensa is a kinase inhibitor that has shown “significant” efficacy in patients with this disease. With this benefit also demonstrated in those with CNS metastases, the treatment could be used in individuals with early-stage disease.

Evidence supporting the US FDA’s regulatory approval

The approval is based on positive results from the Phase III ALINA trial. This study compared the safety and efficacy of adjuvant Alecensa to platinum-based chemotherapy in patients with resected Stage IB (tumor ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC.

Findings from the trial showed that Alecensa reduced the risk of disease recurrence or death in these patients by 76 percent compared to platinum-based chemotherapy. Additionally, exploratory analysis reported an improvement in central nervous system (CNS)-disease-free survival (DFS).

“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,” shared Ken Culver, Director of Research and Clinical Affairs at ALK Positive, Inc.

This new treatment authorisation from the US FDA follows results released on 31 August 2023. At the time of the announcement of the data, Dr Garraway stated that promisingly, if approved, “Alecensa has the potential to treat cancer before it has spread.”

These data were subsequently presented at the European Society of Medical Oncology Congress 2023 Presidential Symposium. Data from the trial were recently published in the New England Journal of Medicine.