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Abbvie/Roche's Leukemia Drugs Combination Gets FDA Approval

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AbbVie, Inc. (ABBV - Free Report) announced that the FDA has granted 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”) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

Venclexta is jointly marketed by AbbVie and Roche’s Pharma arm, Genentech in the United States and by AbbVie outside the United States.

The FDA approval for combination use was based on positive data from the phase III MURANO study of Venclexta plus Rituxan in relapse/refractory CLL

Data from the study, presented in September last year, showed that the combination led to a profound improvement in progression free survival compared to Teva Pharmaceutical’s (TEVA - Free Report) Treanda plus Rituxan(BR). Results from the study showed that a fixed duration of treatment with Venclexta plus Rituxan significantly reduced the risk of disease progression or death by 81% compared with BR. Overall response rate (ORR) was 92% in the Venclexta/Rituxan arm compared to 72% for BR.

Concurrently, the FDA also approved Venclexta as a monotherapy for CLL or SLL patients, with or without 17p deletion. Until now, as a monotherapy, Venclexta was approved to treat patients with CLL with 17p deletion, as detected by an FDA-approved test.

The FDA approval for label expansion of Venclexta for this indication should expand the patient population for Venclexta significantly and boost its commercial potential. With the latest approval, Venclexta/Rituxan becomes the first oral, chemotherapy-free, fixed duration treatment option for CLL patients. 

Also, this summer, AbbVie will file a regulatory application in the United States for Venclexta in acute myeloid leukemia (AML) while a phase III program in multiple myeloma is also progressing well.

AbbVie’s shares have gained 3.8% this year so far against the industry’s decline of 3.7%.

AbbVie currently carries a Zacks Rank #3 (Hold). A better-ranked large-cap pharma stock is Eli Lilly & Company (LLY - Free Report) , with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Lilly’s earnings estimates increased 5.8% for 2018 and 3.2% for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with an average beat of 8.20%. Shares of Lilly have gained 2% this year so far.

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