June 18, 2021
Otsuka Pharmaceutical Co., Ltd.
Approval in Japan for Otsuka's minor BCR-ABL mRNA measurement kit
A marker to monitor treatment effectiveness for acute lymphoblastic leukemia (ALL)
Otsuka Pharmaceutical Co., Ltd. announces today that it has received the first regulatory approval in Japan for the manufacture and sales of the Otsuka minor BCR-ABL mRNA measurement kit as an in-vitro diagnostic product.
The kit is for use diagnostic support and monitor treatment effectiveness for Philadelphia Chromosome- positive acute lymphoblastic leukemia (Ph+ALL) and Otsuka expects that the kit can support identification of the most appropriate treatment opportunities for patients in Japan with ALL.
In patients with ALL, lymphocytes (a type of white blood cell) become malignant at an early stage of differentiation and proliferate unrestrainedly without maturing into functional lymphocytes. Early diagnosis and treatment initiation are important because the condition progresses rapidly The number of patients in Japan was reported to be about 5,000 in a survey by the Japanese MHLW in 2017.
The Diagnostic Division of Otsuka has launched WT1 mRNA Measurement Kit II "Otsuka" and Major BCR-ABL mRNA Measurement Kit "Otsuka" as in-vitro diagnostic agents for blood cancer. Otsuka will continue to contribute to medical treatment with the aim of developing diagnostic agents that can maximize the capabilities of therapeutic agents.
Information in this news release was current as of the original release date.