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  5. A Marker to Monitor Treatment Effectiveness For Chronic Myeloid Leukemia(CML) Approval in Japan for Otsuka's Major BCR-ABL mRNA Measurement Kit

September 16, 2014

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

A Marker to Monitor Treatment Effectiveness For Chronic Myeloid Leukemia(CML)
Approval in Japan for Otsuka's Major BCR-ABL mRNA Measurement Kit

  • Treatment of chronic myeloid leukemia (CML) has made great strides over the past decade following the introduction of molecular targeted cancer therapies. Otsuka's diagnostics division has developed a testing kit that has the world's highest level of detection sensitivity for monitoring treatment effectiveness on CML.
  • With approximately 11,000 CML patients in Japan and that number increasing, and since molecular-level assessment of treatment effectiveness has been limited in Japan up until now, development of a testing kit has been eagerly awaited in order to assess disease relapse and treatment effectiveness using internationally recognized measurement values.
  • The Otsuka Major BCR-ABL mRNA Measurement Kit is capable of measuring minutely residual leukemia cells at the molecular level, which is an international standard. The kit can be used to monitor treatment effectiveness or detect early relapse and thus is expected to contribute to the clinical management of CML.

Tokyo, Japan (September 16) - On September 3, Otsuka Pharmaceutical Co., Ltd. received regulatory approval in Japan for the manufacture and sales of the Otsuka Major BCR-ABL mRNA Measurement Kit as an extracorporeal diagnostic pharmaceutical product meeting international standards for use as an aid to diagnose and monitor treatment effectiveness for chronic myeloid leukemia (CML).


Information in this news release was current as of the original release date.

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