Chugai files for additional tumor-agnostic indication of Alecensa

Japanese drugmaker Chugai Pharmaceutical (TYO:4519) today revealed that it has filed a regulatory application with the Ministry of Health, Labor and Welfare (MHLW) for an additional indication of its anti-cancer agent/ALK inhibitor Alecensa (alectinib) for ALK fusion/rearrangement gene-positive unresectable advanced or recurrent solid tumors, including pediatric patients.

Chugai, which is majority-owned by Roche (ROG: SIX), gained MHLW approval for the drug as a treatment for adjuvant therapy for ALK fusion gene-positive non-small cell lung cancer (NSCLC) in August last year. The drug generated sales of 31 billion yen ($212.6 million) for Chugai in the last fiscal year

“I am very pleased that Alecensa has reached the regulatory application stage as a tumor-agnostic treatment for ALK fusion / rearrangement gene-positive solid tumors. This application represents an important step in expanding the treatment potential of Alecensa beyond non-small cell lung cancer and anaplastic large cell lymphoma, a hematological malignancy, for which it has already been approved, to various solid tumors with ALK fusion / rearrangement genes. We will work toward obtaining approval to deliver Alecensa as a new treatment option to patients with various cancer types as quickly as possible,” said Chugai’s president and chief executive, Dr Osamu Okuda.