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Empliciti on track for European approval in multiple myeloma

CHMP backs BMS and AbbVie's therapy after an accelerated assessment

BMS AbbVie Empliciti elotuzumab

Bristol-Myers Squibb and AbbVie's multiple myeloma therapy Empliciti has been recommended for approval in the EU after an accelerated assessment.

The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Empliciti (elotuzumab) for use in combination with Celgene's Revlimid (lenalidomide) and corticosteroid drug dexamethasone as a second-line therapy for multiple myeloma patients.

Empliciti targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7) and is thought to work by activating the body's immune system to attack and kill multiple myeloma cells.

The immuno-oncology drug was first approved in the US last November and launched the following month at a price of around $10,000 per month, undercutting market leader Revlimid which costs around $14,000.

It is one of four new multiple myeloma therapies that saw their first marketing approvals last year, along with Janssen Biotech's Darzalex (daratumumab), Takeda's Ninlaro (ixazomib) and Novartis' Farydak (panobinostat).

These new products are expected to help drive the global market for multiple myeloma therapies from $8.9bn in 2014 to an estimated $22.4bn by 2023, according to GlobalData.

Despite the increasingly crowded market, the market analysis firm predicts Empliciti could reach peak sales of $4.2bn ahead of Darzalex with sales of $3.7bn in that year.

According to the European Medicines Agency (EMA), in 2012, around 39,000 people had multiple myeloma in the EU. Only half of patients diagnosed with the disease are still alive after five years with currently available treatment.

The CHMP's positive opinion is based on a 646-patient phase III study evaluating Empliciti plus lenalidomide and dexamethasone against lenalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma.

In patients also taking Empliciti, the disease progressed around four months more slowly, and nearly 80% of patients taking BMS and AbbVie's drug saw a complete or partial shrinkage of their tumours compared to 66% in those only taking lenalidomide and dexamethasone alone.

Article by
Phil Taylor

2nd February 2016

From: Regulatory

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