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European Commission Approves Roche's Alecensa as First Targeted Adjuvant Therapy for Early-Stage ALK-Positive Lung Cancer | 2024 | iPharmaCenter

Roche announced that the European Commission has approved Alecensa (alectinib) as the first targeted adjuvant treatment for adults with ALK-positive early-stage non-small cell lung cancer (NSCLC). This landmark approval is based on the Phase III ALINA study, which showed that Alecensa significantly reduced the risk of disease recurrence or death by 76% in patients with resected ALK-positive NSCLC.


The ALINA trial, a Phase III study, involved patients with stage IB (tumor ≥ 4 cm) to IIIA ALK-positive NSCLC who had undergone complete tumor resection.

The results revealed that Alecensa lowered the risk of disease recurrence or death by an unprecedented 76% compared to platinum-based chemotherapy.

This significant finding is particularly relevant given the high recurrence rate among early-stage lung cancer patients post-surgery, even after adjuvant chemotherapy.


Additionally, the study highlighted an improvement in central nervous system disease-free survival, a crucial outcome for ALK-positive NSCLC patients who face a higher risk of brain metastases. The safety profile of Alecensa was consistent with previous trials, with no new safety concerns identified.


Alecensa has transformed the treatment landscape for advanced ALK-positive NSCLC and is already approved in over 100 countries for both first- and second-line treatment. With this new approval, Alecensa can now play a critical role in the adjuvant setting for resectable ALK-positive disease, addressing a significant unmet medical need.

This approval in Europe follows the U.S. FDA's approval in April 2024 for adjuvant use in similar patient populations.


Routine testing for ALK, EGFR, and PD-L1 biomarkers in resected surgical tissue or biopsy from patients with stage IB to IIIA and select IIIB NSCLC is recommended by international guidelines to support clinicians in making informed treatment decisions.


About the ALINA Study

The ALINA study is a Phase III, randomized, active-controlled, multicenter, open-label trial comparing the efficacy and safety of adjuvant Alecensa with platinum-based chemotherapy in patients with resected Stage IB to IIIA ALK-positive NSCLC. The trial included 257 patients randomly assigned to receive either Alecensa or chemotherapy. The primary endpoint was disease-free survival, with secondary endpoints including overall survival and adverse event rates.


About Lung Cancer

Lung cancer remains a leading cause of cancer-related deaths globally, claiming approximately 1.8 million lives annually. NSCLC accounts for about 85% of all lung cancer cases. Despite advancements in treatment, nearly half of early-stage lung cancer patients experience recurrence post-surgery. Early diagnosis and treatment are critical to improving survival rates and achieving potential cures.


About Alecensa (alectinib)

Alecensa is an oral, highly selective, central nervous system-active medication developed by Chugai, a member of the Roche Group, for treating ALK-positive NSCLC.

It is approved in over 100 countries for advanced and metastatic ALK-positive NSCLC. In April 2024, the U.S. FDA approved Alecensa as an adjuvant treatment following tumor resection for patients with ALK-positive NSCLC, and in June 2024, the European Commission granted a similar approval. This new indication allows Alecensa to be used as monotherapy for adults with ALK-positive NSCLC at high risk of recurrence after surgery.

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