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EMA fast-tracks BMS multiple myeloma drug

Published on 01/02/16 at 09:26am
Empliciti pack shot

The EMA has recommended granting a marketing authorisation for Bristol Myers-Squibb and AbbVie’s immunotherapy Empliciti for the treatment of multiple myeloma.

The drug is to be used in combination with Revlimid (lenalidomide) and the anti-inflammatory medicine dexamethasone for the treatment of patients who have received at least one prior therapy.

The Committee for Medicinal Products for Human Use (CHMP) recommendation was based on a Phase III trial comparing the combination of Empliciti/Revlimid/dexamethasone versus Revlimid and dexamethasone in patients with relapsed or refractory multiple myeloma. The trial enrolled 646 patients whose multiple myeloma relapsed after, or did not respond to, previous treatment. In patients also taking Empliciti, the disease progressed an average 4.2 months more slowly than in patients taking only lenalidomide and dexamethasone.

In addition, 78.5% of patients taking Empliciti with lenalidomide and dexamethasone saw a complete or partial shrinkage of their tumours, compared to 65.5% in those only taking lenalidomide and dexamethasone.

The CHMP’s decision is a big step towards full European approval. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation – after which (if successful) EU member states will decide individually whether or not to pay for the drug on their various health systems.

EMA’s approval follows the European regulator granting Empliciti (elotuzumab) orphan designation in 2012, and accelerated assessment last year. This guarantees a decision within 150 days with the aim of making new treatments available quickly in areas of unmet medical need. In 2012, around 39,000 people had multiple myeloma in the European Union. With currently available treatments, only half of patients diagnosed with the disease survive beyond five years.

Multiple myeloma affects the division of plasma cells in the blood, which becomes out of control, resulting in abnormal, immature plasma cells multiplying and filling up the bone marrow. These abnormal cells interfere with the production of normal white blood cells, red blood cells and platelets, which can cause complications including infections, anaemia, bone pain and fractures, raised blood calcium levels and kidney dysfunction.

Myeloma UK chief executive Eric Low welcomed the positive recommendation, calling it a ‘major step forward’ in myeloma treatment. He says: “The evidence we have from clinical trials suggests that Empliciti is an effective drug in a difficult to treat patient population, so it is great to see this positive approval. As we eagerly await the final European Commission guidance it is important that key stakeholders including the various HTA bodies and payers, Myeloma UK and the pharmaceutical company work together to ensure access to Empliciti across the UK as soon as possible.”

Joel Levy

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