[2017/12/19] New Indication for Innomustine®
TAIPEI, Taiwan, R.O.C.—Dec. 01, 2017 -- InnoPharmax Inc. Inc. announced that the Taiwan Food and Drug Administration (TFDA) approved the supplement of new indication application for its Innomustine® Injection (bendamustine hydrochloride) for the treatment of previously untreated indolent CD20-positive, stage III-IV Non-Hodgkin's lymphoma, in combination with rituximab and previously untreated CD20-positive, stage III-IV Mantle Cell Lymphoma in combination with rituximab, in patients ineligible for autologous stem cell transplantation.

  

 Innomustine® Injection was approved for the treatment of Binet stage B and C chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin's lymphoma (NHL) as monotherapy in patients, who have been treated with at least one chemotherapy and progressed within 6 months following treatment with rituximab in Sep. 2011 by TFDA.  Based on the results of clinical studies conducted in Europe and Japan, InnoPharmax submitted the supplement for new indications in March 2017.  The supplement was approved recently by TFDA.  To include the two additional indications in the system of National Health Insurance, InnoPharmax is preparing to amend the reimbursement policy of Innomustine® Injection with National Health Insurance Administration.

 

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