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.
This makes Empliciti the first and only immunostimulatory antibody to be approved for the treatment of multiple myeloma.
Empliciti is also under review in the EU as a combination therapy for the treatment of multiple myeloma patients who have received one or more prior therapies. It has been granted accelerated assessment by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
While AbbVie and Bristol-Myers are co-developing Empliciti, the latter will be solely responsible for commercial activities. Bristol-Myers plans to start shipping the drug in a couple of days.
We are encouraged by the FDA approval of Empliciti. Per information provided by Bristol-Myers in its press release, more than 114,200 new cases of multiple myeloma are diagnosed annually, resulting in more than 80,000 deaths globally. Moreover, it has been observed that the disease remains mostly incurable with less than half the patients surviving for five or more years after diagnosis.
We note that Johnson & Johnson’s JNJ Darzalex (daratumumab) also gained FDA approval last month for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.
Among other approved drugs for the treatment of multiple myeloma are Kyprolis and Velcade.
Currently, both AbbVie and Bristol-Myers are Zacks Rank #3 (Hold) stocks. Achillion Pharmaceuticals, Inc. ACHN is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).
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