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FDA approves BMS and AbbVie’s Empliciti for multiple myeloma

pharmafile | December 1, 2015 | News story | Manufacturing and Production, Sales and Marketing AbbVie, BMS, Bristol-Myers Squibb, Empliciti, FDA, elotuzumab, multiple myeloma 

The US healthcare regulator has approved Empliciti – a multiple myeloma treatment co-developed by Bristol-Myers Squibb and AbbVie.

The FDA signed-off on Empliciti (elotuzumab) as a treatment for multiple myeloma in combination with Celgene’s Revlimid (lenalidomide) and the steroid treatment dexamethasone, in patients who have received one to three prior therapies.

The decision means BMS and AbbVie have gained the first approval of an immuno-stimulatory antibody for multiple myeloma. Increasing the body’s immune responses with these monoclonal antibodies – which are directed to immune-receptor molecules – is strategy increasingly used in cancer therapy. This expanding class of agents functions on crucial receptors, either blocking those that suppress immune responses or activating others that amplify immune responses. BMS’ Yervoy (ipilimumab) is another example of a drug using this type of action.

The approval is based on a Phase III study that demonstrated that the Empliciti, Revlimid and dexamethasone combination reduced the risk of disease progression or death compared by 30% more to Revlimid alone.

Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with BMS solely responsible for commercial activities. The US company says it expects to begin shipping Empliciti, which is available for injection for intravenous use in 300 mg and 400 mg vials, within days. Empliciti is also under review by the European Medicines Agency and has been granted accelerated assessment.

“At Bristol-Myers Squibb, we are leading a revolution in cancer treatment that is changing expectations for patients with some of the hardest-to-treat cancers. With today’s approval of Empliciti, we are pleased to now bring the promise of our immuno-oncology research to patients with multiple myeloma,” says Francis Cuss, chief scientific officer at Bristol-Myers Squibb. “Empliciti represents a fundamentally different approach of directly activating the immune system in patients with relapsed or refractory multiple myeloma, delivering improved outcomes for those in need.”

“Empliciti in combination with lenalidomide and dexamethasone is an important new option for patients with multiple myeloma and healthcare providers who are treating this cancer,” says Michael Severino, who is executive vice president of research and development and chief scientific officer at AbbVie. “AbbVie is pleased to have partnered with Bristol-Myers Squibb in making this new treatment available for patients with relapsed or refractory multiple myeloma.”

Lilian Anekwe

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