|AbbVie's Michael Severino|
AbbVie ($ABBV) and Roche's ($RHHBY) cancer drug venetoclax, awaiting FDA approval, picked up another breakthrough therapy nod from the agency for its potential as part of a combination treatment for leukemia.
The FDA heralded venetoclax's efficacy in chronic lymphocytic leukemia, or CLL, when paired with Roche's Rituxan, an antibody aimed at the cancer-related protein CD20. In a 49-patient clinical trial, the combination of venetoclax, which targets the protein B-cell lymphoma-2, and Rituxan shrank the tumors of 84% of volunteers, ridding 6 patients of their CLL entirely.
The designation marks venetoclax's second breakthrough tag, following the FDA's April decision to confer the same honor on the drug for its results as a monotherapy in CLL patients with a particular genetic mutation. The breakthrough program promises drug developers special access to top FDA officials and the potential of a shorter approval process.
"This second breakthrough therapy designation for venetoclax granted by the FDA underscores the significant potential of this therapy in treating relapsed/refractory CLL patients, and reflects AbbVie's commitment to providing breakthrough therapies for cancer patients," AbbVie Chief Scientific Officer Michael Severino said in a statement.
Meanwhile, AbbVie and Roche are expecting to win a first CLL approval for venetoclax this summer after receiving the FDA's priority review designation earlier this month. The drug's initial indication targets patients with 17p deletion, a tough-to-treat variant that accounts for up to 10% of all CLL cases and as many as half of all relapsed or refractory instances of the cancer, according to AbbVie.
The pair's clinical program also includes late-stage studies in other forms of CLL and mid-stage trials testing the drug against non-Hodgkin's lymphoma, diffuse large B-cell lymphoma, acute myeloid leukemia and multiple myeloma.
Venetoclax's potential success is particularly key for AbbVie, which paid $21 billion for Pharmacyclics last year to get a 50% share of the CLL drug Imbruvica. Management believes Imbruvica can bring in billions each year with the help of an expanded label, and pairing it with venetoclax could create a best-in-class combination, according to the company.
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