FDA Approves Empliciti for Multiple Myeloma

A new blood cancer drug made by Bristol-Myers Squibb at its East Syracuse plant has been approved by the Food and Drug Administration.

The FDA has granted approval to the use of the drug Empliciti for treating patients with multiple myeloma.

AbbVie Inc.ABBV and its partner Bristol-Myers Squibb Company BMY announced that the FDA has approved Empliciti (elotuzumab) in combination with Revlimid (lenalidomide) and dexamethasone for the treatment of multiple myeloma patients who have received one to three prior therapies. The agency has approved Empliciti in combination with two other therapies, Revlimid (lenalidomide) and dexamethasone (a type of corticosteroid), to treat people with multiple myeloma and those who have received one to three prior medications.

Researchers conducted the study on 646 participants whose multiple myeloma came back after or did not respond to previous treatment.

Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. The FDA estimates there will be nearly 27,000 cases of multiple myeloma this year and more than 11,000 deaths related to the cancer.

Empliciti (elotuzumab) is an immuno-stimulatory antibody targeting SLAMF7, a cell-surface glycoprotein that is highly and uniformly expressed on myeloma cells and Natural Killer cells, but not on normal solid tissues or on haematopoietic stem cells. In comparison, patients who were taking only dexamethasone and Revlimid saw 65.5 percent tumor shrinkage. Priority review status is granted to applications for drugs that, if approved, would be a significant improvement in safety or effectiveness in the treatment of a serious condition.

The Wall Street Journal reported the monthly cost of Empliciti for biweekly doses is about $10,000. It is available for injection in 400 mg and 300 mg vials.

Empliciti’s most common side effects included fatigue, diarrhea, fever, constipation, cough, peripheral neuropathy, nasal infection, respiratory infection, loss of appetite, and pneumonia.

Meanwhile, experts believe that the approval of Empliciti offers hope for the multiple myeloma community who urgently need a treatment option which extends the time patients live without their condition progressing.