Thalidomide LipomedMultiple myeloma (MM)
Development and Regulatory status
Recommended for approval (Positive opinion)
Recommended for EU approval by CHMP for use in adults. The proposed indication is “Thalidomide Lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥65 years or ineligible for high dose chemotherapy”. Thalidomide Lipomed will be available as a 100mg coated tablet .
Immunosuppressant, with immunomodulatory, anti-inflammatory and anti-neoplastic effects
Multiple myeloma is responsible for 15-20% of deaths from haematological cancer and ~2% of all deaths from cancer. Incidence in Europe is 4.5-6.0/100,000/year with a mortality rate of 4.1/100,000/year. Median age at presentation is 70 years .
Multiple myeloma (MM)