Bristol-Myers and AbbVie win FDA approval for a 'breakthrough' myeloma treatment

Partners Bristol-Myers Squibb ($BMY) and AbbVie ($ABBV) picked up a speedy FDA approval for their cancer immunotherapy, preparing to launch a key cog in each company's oncology pipeline.

The injection, developed as 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. The FDA approved it to treat multiple myeloma alongside Celgene's ($CELG) Revlimid and the generic corticosteroid dexamethasone, indicating the antibody for patients who have already received at least one prior treatment.

The approval comes about three months ahead of schedule and follows a flurry of FDA activity in multiple myeloma. Earlier this month, the agency approved Takeda's Ninlaro, which joins Johnson & Johnson's ($JNJ) Darzalex and Novartis' ($NVS) Farydak among multiple myeloma treatments cleared this year.

Elotuzumab, to be marketed as Empliciti, is key to AbbVie's future in oncology as it works to build a franchise in blood cancer. This year, the company spent $21 billion for Pharmacyclics and a 50% share of its ​chronic lymphocytic leukemia (CLL) treatment Imbruvica, and management justified that price tag by pointing to the potential of combination therapies. To that end, AbbVie is working with Roche ($RHHBY) on a Phase III CLL treatment called venetoclax in hopes of piecing together a blockbuster cocktail.

For Bristol-Myers, the approval of another immunotherapy bolsters its pole position among companies with so-called checkpoint inhibitors, which similarly expose cancer cells to immune system attack. The company's Opdivo has won FDA approvals in melanoma and lung cancer and currently leads a class of similar therapies analysts say could bring in more than $30 billion a year at their peak.

Empliciti, which received the FDA's breakthrough therapy designation, has taken a circuitous path to approval. 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.

- read the statement

Read more on