[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]

• Alecensa receives approval based on the results of a Japanese investigator initiated study in children and adults with the rare disease?ALK?fusion gene-positive anaplastic large-cell lymphoma (ALK-positive ALCL)
• Alecensa is now available as a new treatment option for recurrent or refractory ALK-positive ALCL

TOKYO, February 21, 2020 --?Chugai Pharmaceutical Co., Ltd.?(TOKYO: 4519) announced today that?it has obtained approval for its anti-cancer agent/ALK inhibitor, Alecensa^??capsule 150 mg (nonproprietary name: alectinib hydrochloride)?from the Ministry of Health, Labour and Welfare for an additional indication of recurrent or refractory?ALK?fusion gene-positive anaplastic large-cell lymphoma. ?Chemotherapy is usually used for the treatment of ALCL. However, standard therapies have not been established in patients with post-chemotherapy recurrent ALCL, resulting in a growing demand for new pharmaceutical products,??said Dr. Osamu Okuda, Chugai?s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. ?The approval for the additional indication of Alecensa will offer a new treatment option to patients with these unmet medical needs. We will strive to make Alecensa as one of the standard therapies for ALK-positive non-small cell lung cancer, with the aim of making a significant contribution to the treatment of hematologic cancers.? This approval is based on the results from the investigator initiated study (the ALC-ALCL study) started in May 2015. The study was conducted as a part of the ?Research Project on Practical Application of Innovative Cancer Therapy? by Japan Agency for Medical Research and Development.?In the ALC-ALCL study, the response rate (primary endpoint, assessed by the central review committee) and safety were evaluated in 10 patients with relapsed or refractory ALK-positive ALCL who are 6 years or older (6-70 years). The response rate which was the primary endpoint was 80.0% (two-sided 90% confidence interval: 56.15-95.91%).?The incidence of adverse reactions was 100.0%. The most common adverse reactions were maculopapular rash (40.0 %, 4/10 cases), upper respiratory tract infection, bronchitis and increased blood alkaline phosphatase (30.0 %, 3/10 cases),?respectively. [Reference information] Media release issued by Chugai on June 3, 2019 Title: Chugai Files for Additional Indication of ALK Inhibitor ALECENSA for Recurrent or Refractory?ALK?Fusion Gene-Positive Anaplastic Large Cell Lymphoma (ALCL) https://www.chugai-pharm.co.jp/english/news/detail/20190603163000_622.html

Prescribing Information?*The underlined parts were newly added.

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