The Food and Drug Administration has given its first approval to a single-agent immunotherapy for cancer – Amgen Inc’s Blincyto (blinatumomab) for the treatment of refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
A kinase inhibitor which is already authorised for myelofibrosis has now been approved by the Food and Drug Administration for polycythemia vera, another bone marrow disorder. The drug, Jakafi (ruxolitinib), was developed by Incyte Pharmaceuticals Inc and Novartis.
After issuing a complete response letter in late 2013, the Food and Drug Administration has now approved Lemtrada (alemtuzumab) for patients with relapsing multiple sclerosis. This follows a review of efficacy data from two Phase 3 trials.
Olaparib, a drug with an unusual clinical history, has been given a positive scientific review by the European Medicines Agency paving the way for its use as a treatment for women with a subtype of ovarian cancer.
The European Medicines Agency said that it now has procedures in place to review data on candidate vaccines or therapies aimed at protecting or treating patients infected with the Ebola virus with a view to making these medicines available as quickly as possible.
The US Food and Drug Administration has approved the first combination pill to treat chronic hepatitis C virus genotype 1 infection. Harvoni (ledipasvir and sofosbuvir) is also the first treatment that doesn’t require co-administration with interferon or ribaviron.
The European Medicines Agency’s Committee for Advanced Therapies (CAT) is recommending that the marketing authorisation for the cartilage implant Maci be suspended because the developer, Genzyme (Sanofi SA), has closed the product’s EU manufacturing site.
From 1 January 2015, the European Medicines Agency will begin to publish clinical data used by companies to support their applications to market new drugs in the EU – a policy that is expected to have wide-ranging implications for medicines research across Europe.
For the first time, two patients suffering from a rare genetic blood disorder, for which there is currently no approved medicine, participated in a discussion at the main scientific committee of the European Medicines Agency where a candidate medicine for their disease was being reviewed.
The European Medicines Agency has given positive opinions for 15 new medicines including treatments for hepatitis C infection, Cushing’s syndrome and for non-small cell lung and gastric cancers. The decisions were announced on 26 September.