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AbbVie's Venclexta Multiple Myeloma Studies Put on Hold by FDA

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AbbVie, Inc. (ABBV - Free Report) announced that the FDA has placed a partial clinical hold on all studies evaluating its leukemia drug, Venclexta (venetoclax) for the treatment of multiple myeloma. The decision was taken after, in the ongoing phase III BELLINI study, a higher proportion of deaths were observed in the Venclexta arm compared to the control arm of the study.

Following the observation, it has been instructed that until the data is further analyzed, no new patients should be enrolled in any studies of Venclexta for multiple myeloma. Meanwhile, those who are already enrolled in multiple myeloma studies and receiving benefit from Venclexta have been instructed to continue with treatment after consulting their doctor

Venclexta is presently approved for other cancer types like newly-diagnose chronic lymphocytic leukemia (CLL) and second-line treatment of certain acute myeloid leukemia (AML) patients. The clinical hold does not impact any of the approved indications for Venclexta. It is presently not approved to treat multiple myeloma.

The BELLINI study is evaluating the safety and efficacy of Venclexta plus Takeda’s Velcade (bortezomib) and dexamethasone in patients with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and have received one to three prior lines of therapy. The combination is being compared to treatment with Velcade, dexamethasone and placebo.

AbbVie’s stock has declined 12.3% this year so far against an increase of 3.7% recorded by the industry.



Venclexta is jointly marketed by AbbVie and Roche’s (RHHBY - Free Report) 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.

For AbbVie, Venclexta brought in revenues of $344 million in 2018, up more than 100% year over year driven by uptake in the second-line plus setting following approval in the United States as well as EU in the broad relapsed/refractory CLL segment (MURANO study) in 2018. Venclexta is a key drug in AbbVie’s oncology portfolio.

AbbVie is studying Venclyxto/Venclexta to expand the 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. As mentioned above, regulatory applications seeking approval for Venclexta plus Rituxan for relapse/refractory CLL (based on MURANO study data) were approved in the United States and in the EU in 2018.

Data from the phase III MURANO study of Venclexta plus Rituxan in relapse/refractory CLL showed that the combination led to a profound improvement in progression free survival compared to Teva’s (TEVA - Free Report) Treanda plus Rituxan. In November 2018, AbbVie gained FDA approval for Venclexta in first-line AML. Label expansion for these indications has expanded the patient population of Venclexta significantly. However, pipeline setbacks like the clinical hold on the multiple myeloma studies will hurt the growth prospects of this important oncology drug.

Another important cancer drug in AbbVie’s portfolio is Imbruvica, which it markets in partnership with J&J (JNJ - Free Report) . Imbruvica, currently approved for quite a few indications, has multi-billion dollar potential. AbbVie is exploring the potential to expand 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.

AbbVie currently carries a Zacks Rank #3 (Hold). You can seethe complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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