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BMS' Empliciti approved by FDA for multiple myeloma

Clearedfor use in with Celgene's Revlimid and corticosteroid dexamethasone

BMS Bristol-Myers Squibb Emplicitis elotuzumab 

Bristol-Myers Squibb's Empliciti has become the third new treatment approved for multiple myeloma in the US in a fortnight.

Empliciti (elotuzumab) has been cleared by the FDA for use in combination with two other drugs - Celgene's proteasome inhibitor Revlimid (lenalidomide) and the corticosteroid dexamethasone - in patients with multiple myeloma who have received between one and three prior treatment regimens.

BMS says the drug - which targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7) and stimulates immune responses against tumour cells - is the first and only immuno-stimulatory antibody for multiple myeloma.

The approval comes two weeks after Janssen Biotech's Darzalex (daratumumab) became the first antibody to be given a green light by the FDA for myeloma, and a few days after the agency gave the go-ahead to Takeda's Ninlaro (ixazomib), the first orally-active proteasome inhibitor to reach the market. Novartis' Farydak (panobinostat) also became the first HDAC inhibitor to be approved for myeloma back in February.

The new therapies provide new options for patients with multiple myeloma, the second most common form of blood cancer. It occurs in infection-fighting plasma cells found in the bone marrow and afflicts around 27,000 people a year in the US, causing more than 11,000 deaths.

The roll-out of new therapies is predicted to expand the market for myeloma therapies in eight major markets - the US, UK, France, Germany, Italy, Spain, Japan and Canada - from a level of $7.3bn last year to almost $9bn by 2021, according to GBI Research.

Empliciti has been given the nod on the back of the ELOQUENT-2 trial, which showed that patients taking Empliciti plus Revlimid and dexamethasone experienced a delay in the amount of time before their disease worsened (19.4 months) compared to participants taking only Revlimid and dexamethasone (14.9 months).

All told, 78.5% of those taking the Empliciti regimen experienced a complete or partial shrinkage of their tumours compared to 65.5% of those taking Revlimid and dexamethasone alone. 

Empliciti is also being tested in trials involving treatment-naïve myeloma patients and those with 'smouldering' multiple myeloma (SMM), an early stage of the disease in which patients have markers for disease activity but no overt symptoms.

Walter Capone, chief executive of the Multiple Myeloma Research Foundation (MMRF) in the US, said: "The approval of elotuzumab marks another important milestone in the treatment of multiple myeloma in a short period of time."

Article by
Phil Taylor

1st December 2015

From: Sales, Regulatory

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