The Food and Drug Administration has approved the use of Avastin (bevacizumab) with chemotherapy to treat advanced cervical cancer – the first biologic to be authorised for this indication in combination with other agents.
In separate decisions, regulatory authorities in the US and Europe have paved the way for the introduction of two new medicines for different blood cancers – substantially increasing the treatment options for patients with a number of rare cancers.
A Phase 3 trial of a combination therapy for metastatic melanoma has been stopped early because an interim analysis showed an overall survival benefit for the treatment group compared with the control, according to the developer GlaxoSmithKline Plc.
Pharming Group NV of the Netherlands has received approval to market its drug for hereditary angioedema (HAE), Ruconest, in the US following approval by Food and Drug Administration. The approval comes nearly four years after the drug was authorised for marketing in Europe.
The US Food and Drug Administration has approved a new histone deacetylase (HDAC) inhibitor developed by Topotarget of Denmark to treat patients with peripheral T cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma.
Arzerra (ofatumumab), a monoclonal antibody that targets CD20, has been approved in Europe for a new use in patients with chronic lymphocytic leukaemia – this time as a first-line combination therapy for those who are ineligible for fludarabine chemotherapy.
The European Medicines Agency’s main scientific committee is recommending approval of a second new treatment for hepatitis C virus infection that doesn’t require co-administration with interferon. Daklinza (daclatasvir) is the latest in a new class of direct-acting antivirals.
The European Medicine Agency has announced a review of ibuprofen medicines taken at high doses because of the risk of cardiovascular disease. The review covers medicines taken orally, but not topical treatments such as creams and gels.
The European Medicines Agency has selected the first two of what may be several medicines to be reviewed under its ‘adaptive licensing’ pilot project. The agents, which haven’t been identified, will be examined by stakeholders, including HTA bodies, to determine their suitability for future marketing.
The US Food and Drug Administration has approved a new recombinant product for the treatment of Haemophilia A, an inherited, sex-linked blood clotting disorder that is caused by defects in the Factor VIII gene.