Partners Roche ($RHHBY) and AbbVie ($ABBV) are speeding toward FDA approval with a cancer treatment tabbed as a potential blockbuster, picking up a priority review for a blood cancer therapy.
The drug, venetoclax, is up for a shortened 6-month FDA review in chronic lymphocytic leukemia after receiving the FDA's breakthrough therapy designation.
In Phase II trials, the treatment met its main goal of beating back cancer growth in CLL. Venetoclax, formerly ABT-199, is designed to block the protein B-cell lymphoma-2, which can help cancer cells survive in the blood. The drug's first target is patients who have CLL with a 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.
AbbVie and Roche are taking a broad approach to blood cancer with venetoclax, running 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.
The drug's future is particularly vital to AbbVie, which paid $21 billion for Pharmacyclics last year to get a 50% share of the CLL drug Imbruvica. AbbVie believes Imbruvica can bring in billions a year with the help of a widened label, and pairing it with venetoclax could create a best-in-class combination, according to the company.
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