The European Medicines Agency said June 22 that it had recommended an extension of indication for the cancer drug everolimus to treat hormone receptor–positive, HER2–negative advanced breast cancer.
Everolimus (Afinitor, Novartis), already recommended by the EMA to treat pancreatic and renal cell cancers, is now recommended throughout the European Union in combination with exemestane as a second-line treatment in postmenopausal women in whom aromatase inhibitors have failed.
EMA also extended indications of agents used to treat two rheumatic diseases.
Etanercept (Enbrel), marketed by Pfizer and already licensed in Europe to treat rheumatic arthritis in adults, is now recommended as a treatment for polyarthritis (rheumatoid factor positive or negative), extended oligoarthritis, and psoriatic arthritis in children and adolescents in whom methotrexate has failed or is inappropriate. The indication for etanercept also was extended to treatment of enthesitis-related arthritis in adolescents 12 years and older not responding to conventional therapy.
Adalimumab (Humira), marketed by Abbott and licensed in Europe to treat a range of rheumatic diseases, will now be indicated for the treatment of adults with severe axial spondyloarthritis who have had an inadequate response to, or are intolerant of, nonsteroidal anti-inflammatory drugs. The new indication covers patients without radiographic evidence of axial spondyloarthritis but with evidence of inflammation determined by MRI or elevated C-reactive protein.
Also at its June meeting, the agency recommended a new six-in-one combination vaccine developed for use outside the European Union. Hexaxim, marketed by Sanofi Pasteur, will be used in children aged 6 weeks to 2 years old to inoculate against diphtheria, tetanus, pertussis, hepatitis B, polio, and diseases caused by Haemophilus influenzae type B, including meningitis. The vaccine is administered as three doses 4 or more weeks apart.
Five of the active substances in the vaccine have been used in other vaccines and have been previously combined in Pentaxim, also manufactured by Sanofi Pasteur. The new vaccine adds Hansenula polymorpha-derived recombinant hepatitis B surface antigen. Clinical trials in Argentina, Mexico, Peru, Turkey, Thailand, and South Africa found the new vaccine to be as effective and safe as Pentaxim plus a monovalent hepatitis B vaccine, EMA said.
EMA recommended three additional new medications:
• Teduglutide (Revestive, Nycomed), a subcutaneous injection to treat short-bowel syndrome, a condition in which nutrients are not absorbed as a result of severe intestinal disease or the surgical removal of a large portion of the small intestine.
• Glycopyrronium bromide (Enurev, Novartis), a maintenance bronchodilator treatment for symptom relief in adults with chronic obstructive pulmonary disease.
• Ceftaroline fosamil (Zinforo, AstraZeneca), an infusion for treatment of adults with complicated skin and soft-tissue infections and community-acquired pneumonia.
The agency also announced that it was restricting indications for two medications on safety concerns. Following reports from Germany of hypersensitivity reactions, the agency advised clinicians not to prescribe tolperisone for indications other than poststroke spasticity and to use oral formulations in place of injectable ones. Tolperisone is a muscle relaxant used in Europe since the 1960s and only available in a handful of countries.
EMA recommended restricting the use of trimetazidine to second-line, add-on therapy after reports from France of movement disorders including Parkinsonian symptoms, restless leg syndrome, tremors and gait instability associated with the medicine. Trimetazidine-containing medicines have been available since the 1970s in Europe and are used in the treatment of patients with angina pectoris. Clinicians are also advised not to prescribe in patients with these and related movement disorders, or those who have severe renal impairment.
All EMA recommendations require European Commission approval to be final.