Japanese drugmaker Chugai Pharmaceutical (TYO: 4519) says its Taiwan subsidiary (CPT) has obtained an import drug license from the Taiwan Food and Drug Administration (TFDA) for Alecensa (alectinib) as an adjuvant treatment following tumor resection (tumors ≥ 4 cm or node positive) for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
CPT is responsible for the development, regulatory submission, import, and sales of Chugai-originated products 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.
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