The European regulator’s Committee for Medicinal Products in Human Use has issued a whole host of decisions which include recommendations for an extension to the labels of Novartis’ Aclasta and Johnson & Johnson’s Velcade.
The CHMP has recommended that the label on Aclasta (zoledronic acid) be expanded to include the treatment of osteoporosis in post-menopausal women and men at increased risk of fracture, including those with a recent low-trauma hip fracture. The drug is currently indicated for use in post-menopausal women and for the treatment of Paget’s disease.
J&J’s Velcade (bortezomib) has been given a provisional green light for its use in combination with melphalan and prednisone for the treatment of patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with bone marrow transplant. It is currently indicated as monotherapy for patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation.
However the CHMP had some bad news for Sanofi-Aventis. The agency adopted a negative opinion for an extension of indication of Taxotere (docetaxel) to be used to treat operable breast cancer whose tumours overexpress the protein HER2.
