Taiwan FDA Nods Chugai's Alecensa To Treat ALK positive NSCLC

Chugai Pharmaceutical Co., Ltd. reported the announcement of Chugai Pharma Taiwan Ltd. Chugai's subsidiary CPT received a license from TFDA to import Alecensa for ALK-positive NSCLC patients post-tumour resection. CPT manages the development, regulatory submission, import, and sales of products that originate from Chugai in Taiwan.

“We are very pleased that Alecensa has been approved in Taiwan as adjuvant therapy for early-stage ALK-positive NSCLC. The results of the ALINA study, which demonstrated a 76% reduction in the risk of recurrence or death, have generated significant anticipation in clinical settings. We believe this approval will have a positive impact on lung cancer treatment in Taiwan. We remain committed to delivering this medication to patients awaiting treatment as swiftly as possible,” said Takashi Okamoto, president of CPT.

The endorsement comes from findings of the ALINA study, a worldwide phase 3 clinical trial of Alecensa as a supplementary treatment in individuals with fully removed IB (tumor = 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC.

The ALINA trial [NCT03456076] is a phase III, multicenter, open-label study comparing the effectiveness and safety of adjuvant Alecensa (alectinib) versus platinum-based chemotherapy in individuals with resected Stage IB to IIIA anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). The research involved 257 patients who were assigned randomly to either the Alecensa or chemotherapy group. The main focus is on the survival without disease. Secondary measures consist of overall survival and the proportion of patients experiencing adverse events.