Chugai's Alecensa Receives TFDA Approval for ALK-Positive NSCLC in Taiwan

Chugai Pharmaceutical announced that Chugai Pharma Taiwan, a wholly-owned subsidiary of Chugai, had received an import drug license from the Taiwan Food and Drug Administration (TFDA) for Alecensa® (alectinib), a product of Chugai, to be used as an adjuvant treatment for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who had had their tumours removed (tumours 4 cm or node positive). In Taiwan, Chugai-originated product development, regulatory filing, import, and sales fall within the purview of CPT.

The approval of Alecensa as an adjuvant treatment for early-stage ALK-positive NSCLC in Taiwan brings us great satisfaction. Clinical settings are eagerly awaiting the outcomes of the ALINA research, which showed a 76% reduction in the probability of death or recurrence. We think Taiwan's lung cancer therapy will benefit from this approval. Takashi Okamoto, President of CPT, stated, "We are still dedicated to provide this drug to patients who are waiting for treatment as soon as feasible.

Based on the outcomes of the worldwide Phase 3 ALINA research, which evaluated Alecensa as an adjuvant treatment for patients with fully resected IB (tumour ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC, the approval was granted.