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Velcade in combination with Dexamethasone, or with Dexamethasone and Thalidomide in multiple myeloma


The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Velcade ( Bortezomib ).

The CHMP adopted a new indication as follows: Velcade in combination with Dexamethasone, or with Dexamethasone and Thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high dose chemotherapy with haematopoietic stem cell transplantation.

For information, the full indication(s) for Velcade will be as follows:

a) Velvade as monotherapy is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation;

b) Velcade in combination with Melphalan and Prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high dose chemotherapy with haematopoietic stem cell transplantation.

c) Velcade in combination with Dexamethasone, or with Dexamethasone and Thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high dose chemotherapy with haematopoietic stem cell transplantation.

More than 1 in 5 patients ( 20% ) receiving Velcade have experienced the following side effects: nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia ( nerve pain ), anemia, leukopenia ( low levels of white blood cells ), constipation, vomiting, lymphopenia ( low levels of a certain type of white blood cells ), rash, pyrexia ( fever ), and anorexia. ( Xagena )

Source: European Medicines Agency ( EMA ), 2013

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