AbbVie's Imbruvica Combo Gets FDA Nod for Rare Lymphoma

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AbbVie, Inc.ABBV and partner J&J JNJ announced that the FDA has granted approval to a supplemental new drug application (sNDA) looking for label expansion of their cancer drug Imbruvica in combination use with Roche's RHHBY Rituxan (rituximab) for the treatment of Waldenström's macroglobulinemia (WM), a rare form of Non-Hodgkin's lymphoma.

The approval was based on data from the phase III iNNOVATE study evaluating Imbruvica plus Rituxan compared to Rituxan alone for the treatment of adult patients with Waldenström's macroglobulinemia. Data from the study showed that the combination significantly reduced the risk of disease progression or death by 80% compared to placebo plus Rituxan.The data also showed that treatment with the combination led to a 30-month progression-free survival rate of 82% compared to 28% for patients on Rituxan alone. The approval came about two months ahead of expectations.

AbbVie's stock has risen 1.3% this year so far, underperforming the industry 's increase of 5.6%.

With the latest approval, Imbruvica is approved for nine indications across six different cancer types. It is jointly developed and commercialized by J&J and AbbVie.

Imbruvica is a key revenue driver at AbbVie and has multi-billion dollar potential. The drug generated revenues of $850 million in the second quarter of 2018, representing an increase of 35.6% year over year. Strong patient uptake including higher market share and growth across multiple indications, particularly chronic lymphocytic leukemia (CLL) led to the strong performance of Imbruvica. The latest label expansion approval for Imbruvica can drive sales higher in future quarters.

AbbVie is exploring the prospect of expanding Imbruvica's label into solid tumors and autoimmune diseases. Several studies on Imbruvica are ongoing to evaluate the drug alone or in combination in different patient segments. AbbVie expects Imbruvica peak sales of more than $7 billion and revenues of about $5 billion in 2020.

Another important cancer drug in AbbVie's oncology portfolio is Venclyxto/Venclexta. AbbVie is also 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 AML. Data from the phase III MURANO study of Venclexta plus Rituxan in relapse/refractory CLL presented in September showed that the combination led to a profound improvement in progression free survival compared to Teva's TEVA Treanda plus Rituxan.

Regulatory applications seeking approval for the combination use in this broader patient population were approved in the United States in June. Label expansion for this indication should expand the patient population for Venclexta significantly and boost its commercial potential. Also, in July, AbbVie filed U.S. regulatory application for Venclexta in first-line of acute myeloid leukemia (AML) while data from the late-stage program in multiple myeloma is expected in 2019.

AbbVie currently has a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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