Bristol-Myers and AbbVie speed toward FDA approval with a 'breakthrough' cancer drug

A new drug for blood cancer from Bristol-Myers Squibb ($BMY) and AbbVie ($ABBV) is on the fast track to FDA approval, winning a priority review to treat multiple myeloma.

The antibody, elotuzumab, is designed to train the immune system's attention on a protein called SLAMF7, expressed by tumor cells that might otherwise go unnoticed by the body's natural defenses. With the priority review tag, the agency promises to give Bristol-Myers and AbbVie a final decision within 6 months, shortening the standard 10-month time frame.

The pair plans to market elotuzumab as Empliciti, aiming to use the drug as part of a cocktail for multiple myeloma patients who have already undergone one or more rounds of therapy. In Phase III results submitted to the FDA, a combination of elotuzumab, Celgene's ($CELG) Revlimid and generic dexamethasone beat out the two older drugs on their own. The antibody picked up the FDA's coveted breakthrough-therapy designation last year based on positive Phase II data, guaranteeing its makers access to top agency officials through the development process.

Elotuzumab has taken a winding path to FDA review. In 2008, Bristol-Myers licensed the drug from PDL BioPharma for $30 million up front just before PDL spun off its biotech division into a company called Facet. Abbott Laboratories ($ABT) bought Facet for $450 million in 2010 and then spun off its proprietary pharma business into AbbVie in 2013, effectively partnering the new company with Bristol-Myers in the process.

Now the pair are working together to fortify their respective oncology portfolios.

For Bristol-Myers, success with elotuzumab would follow its headline-grabbing work with Opdivo, an antibody that marshals an immune system attack on cancer by blocking the protein PD-1 and leads a new pack of oncology treatments poised to bring in more than $30 billion at its peak.

As for AbbVie, the Illinois drugmaker is looking to build out a franchise in blood cancer after splurging $21 billion for Pharmacyclics and a 50% share of its ​chronic lymphocytic leukemia (CLL) treatment Imbruvica. Alongside partner Roche ($RHHBY), AbbVie is speeding ahead with the Phase III CLL treatment venetoclax in hopes of piecing together a blockbuster combo.

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