EC Approves Roche's Alecensa for Early-Stage Lung Cancer Treatment

Roche has secured a significant milestone with the European Commission's (EC) approval of Alecensa (alectinib) as the inaugural targeted adjuvant therapy for patients with early-stage, ALK-positive lung cancer. This approval pertains specifically to adults with non-small cell lung cancer (NSCLC) at a high risk of recurrence, who will now have Alecensa available as a monotherapy.

The decision from the EC was heavily influenced by the auspicious results from the late-stage ALINA study. Roche revealed that Alecensa was able to reduce the risk of disease recurrence by an impressive 76% when compared to platinum-based chemotherapy in patients whose ALK-positive NSCLC had been completely resected, spanning stages 1b to 3a. This represents a considerable advancement in the treatment protocol for this patient cohort.

Moreover, an exploratory analysis indicated that patients receiving Alecensa experienced improved central nervous system disease-free survival. Importantly, the safety and tolerability profile of Alecensa remained consistent with previous trials conducted in metastatic settings, thereby reinforcing its reliability and efficacy.

Globally, lung cancer remains one of the leading causes of cancer-related deaths, with NSCLC accounting for up to 85% of all lung cancer cases. Despite the current standard of care involving adjuvant chemotherapy, approximately half of all patients with early-stage lung cancer face cancer recurrence post-surgery.

Levi Garraway, Roche’s Chief Medical Officer and head of global product development, hailed the EC's decision as a landmark for individuals who traditionally faced a significant risk of their cancer returning after surgical intervention. He emphasized that this is the first instance in Europe where patients who have undergone surgical resection of ALK-positive NSCLC can be treated with an ALK inhibitor, significantly lowering the risk of disease recurrence or mortality.

Alecensa, which was initially developed at Chugai, a Roche Group member, has already garnered approval in over 100 countries as both a first-line and second-line treatment for ALK-positive, metastatic NSCLC. This latest endorsement from the European Commission follows closely on the heels of the drug's approval by the US Food and Drug Administration (FDA) as an adjuvant treatment for ALK-positive NSCLC patients post-tumour resection, contingent on detection through an FDA-approved test.

Roche’s recent accomplishments are not confined to Alecensa alone. The company also received approval from the US regulator for its human papillomavirus self-collection solution. This innovation aims to eliminate current barriers to cervical cancer screening by providing an alternative to traditional clinician collection methods, thus potentially increasing screening accessibility and compliance.

In summary, Alecensa's approval by the EC marks a pivotal development in the treatment landscape for early-stage, ALK-positive NSCLC patients. With its proven efficacy in reducing the risk of recurrence and consistent safety profile, Alecensa stands to significantly improve patient outcomes following surgical resection. This advancement underscores Roche’s commitment to pioneering targeted therapies that address critical needs within the oncology community.