Chugai Pharma's Alecensa Bags European Nod for Adjuvant Treatment

India Pharma Outlook Team | Tuesday, 11 June 2024

Chugai Pharmaceutical Co, a drug manufacturer declared that the European Commission has sanctioned a Chugai originated anaplastic lymphoma kinase (ALK) inhibitor Alecensa monotherapy, as adjuvant treatment following growth resection for grown-up patients with ALK-positive non-small cell lung cancer (NSCLC) at high risk of recurrence. The marketing authorization application was supported by data from the phase III ALINA trial, which demonstrated that Alecensa reduced the risk of disease recurrence or death in patients with resected ALK-positive NSCLC by 76%.1

“We are very pleased that Alecensa, a Chugai originated medicine, received approval in Europe following the US approval for adjuvant treatment of ALK-positive early-stage NSCLC. We believe that this approval will have a significant impact, providing a new treatment opportunity for patients who have dealt with the risk of recurrence even after undergoing tumour resection. We remain committed to working with Roche to bring the benefits of this drug to patients around the world.” said Chugai’s president and CEO, Dr. Osamu Okuda.

In the ALINA study, Alecensa diminished the risk of illness repeat or death by 76% contrasted and platinum-based chemotherapy in individuals with totally resected IB (growths = 4 cm) to IIIA (UICC/AJCC seventh version) ALK-positive NSCLC. In an exploratory examination, an improvement of central nervous system illness free endurance was noticed contrasted and platinum-based chemotherapy. This is especially important for people with ALK-positive NSCLC, who are more likely than people with other types of NSCLC to develop brain metastases. The wellbeing and tolerability of Alecensa in the ALINA preliminary were for the most part predictable with past clinical study in the metastatic setting and no unexpected security discoveries were noticed.

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