AbbVie, Inc. (ABBV - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for label expansion of its leukemia drug, Venclexta. The label expansion application sought EU approval for the combination use of its cancer drug Venclexta and Roche’s (RHHBY - Free Report) Rituxan for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (“CLL”) who have received at least one prior therapy. If approved, Venclexta/Rituxan will become the first chemotherapy-free, fixed duration treatment option for CLL patients.
Regulatory applications seeking approval for the combination use in this broader patient population were approved in the United States in June.
The FDA approval and regulatory applications in the EU for the combination use were based on positive data from the phase III MURANO study of Venclexta plus Rituxan in relapse/refractory CLL. Data from the phase III MURANO study presented last year showed that the combination led to a profound improvement in progression free survival compared to Teva’s (TEVA - Free Report) Treanda plus Rituxan.
Venclexta is jointly marketed by AbbVie and Roche’s Pharma arm, Genentech in the United States and by AbbVie outside the United States. Venclexta is marketed by the trade name of Venclyxto in the EU.
The FDA approval for label expansion of Venclexta for this indication should expand the patient population for the drug significantly and boost its commercial potential.
Meanwhile, AbbVie is studying Venclyxto/Venclexta to expand its label to address the broader relapsed/refractory CLL patient population, expand into earlier lines of therapy and broaden into other hematologic malignancies like multiple myeloma and acute myeloid leukemia (AML).
In July, AbbVie also filed a U.S. regulatory application for Venclexta in first-line AML while data from the phase III program in multiple myeloma is expected in 2019.
So far this year, AbbVie’s stock has declined 4.6% against the industry’s increase of 7.1%.
In fact, last week, AbbVie fell 3.6% following a lawsuit filed by the California insurance department. The lawsuit accused AbbVie of giving illegal kickbacks to doctors to prescribe its top-selling drug Humira, a treatment for rheumatoid arthritis and other inflammatory conditions.
AbbVie currently has a Zacks Rank #3 (Hold). A better-ranked large-cap drug stock is Bristol-Myers Squibb Company (BMY - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings estimates increased 3.4% for 2018 and 2.7% for 2019 over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 6.39%. Shares of the company have risen 13.9% in the past three months.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce ""the world's first trillionaires,"" but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>