- 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.
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)
About ALK-positive anaplastic large-cell lymphoma (ALCL)
ALCL is non-Hodgkin's lymphoma originated in T-cells in lymphocytes, which is one of four subtypes of peripheral T-cell lymphoma classified as malignant lymphoma. The malignancy is categorized as “intermediate-grade,” in which disease progression is observed on a monthly basis. In Japan, the percentage of ALCL in malignant lymphomas is from 1.5 to 2.0%1, 2), about half of which have been reported as ALK-positive.3,4) Considering that the 5-year survival rate with successful treatment has been reported to be 60% in patients with ALK-positive ALCL who received chemotherapy in another global study, the percentage of recurrent and refractory cases is estimated to be 40%.3)
Prescribing Information *The underlined parts were newly added.
|Product name:||Alecensa® capsule 150 mg|
|Nonproprietary name:||alectinib hydrochloride|
|Indications:||○ALK fusion gene positive unresectable, recurrent / advanced non-small cell lung cancer
○Recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma
|Dosage and administration:||
〈ALK fusion gene-positive unresectable, recurrent or advanced non-small cell lung cancer〉
〈Recurrent or refractory ALK positive anaplastic large-cell lymphoma〉
Trademarks used or mentioned in this release are protected by law.
- Lymphoma Study Group of Japanese Pathologists. The World Health Organization classification of malignant lymphomas in Japan: Incidence of recently recognized entities. Pathol Int. 2000 Sep; 50(9): 696-702
- Aoki R, Karube K, Sugita Y, Nomura Y, Shimizu K, Kimura Y, et al. Distribution of malignant lymphoma in Japan: Analysis of 2260 cases. 2001-2006. Pathol Int. 2008 Mar; 58(3): 174-82
- Savage KJ, Harris NL, Vose JM, Ullrich F, Jaffe ES, Connors JM, et al. ALK- anaplastic large-cell lymphoma is clinically and immunophenotypically different from both ALK+ ALCL and peripheral Tcell lymphoma, not otherwise specified: report from the International Peripheral T-Cell Lymphoma Project. Blood. 2008 Jun 5; 111(12): 5496-504
- Sibon D, Fournier M, Brière J, Lamant L, Haioun C, Coiffier B, et al. Long-Term Outcome of Adults With Systemic Anaplastic Large-Cell Lymphoma Treated Within the Groupe d'Étude des Lymphomes de l'Adulte Trials. J Clin Oncol. 2012 Nov 10; 30(32): 3939-46
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