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AbbVie (ABBV) Venclexta Gets Breakthrough Therapy Tag for MDS

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AbbVie Inc. (ABBV - Free Report) announced that the FDA has granted a Breakthrough Therapy designation to Venclexta (venetoclax) in combination with azacitidine for the potential treatment of adult patients with previously untreated intermediate-, high- and very high-risk myelodysplastic syndrome (“MDS”) based on the revised International Prognostic Scoring System.

This is the sixth Breakthrough Therapy tag granted to Venclexta for a cancer indication, including tough-to-treat myeloid malignancies.

A Breakthrough Therapy status is granted to medicines being evaluated for serious conditions where early clinical evidence indicates said medicines’ potential for substantial improvement over available therapies.

The above designation was based on data from the phase Ib M15-531 study. The company is also investigating Venclexta+azacitidine in the phase Ib M15-522 study for the treatment of MDS in patients with relapsed/refractory disease. The phase III VERONA study is evaluating Venclexta plus azacitidine in patients with newly diagnosed higher-risk MDS.

Shares of AbbVie have rallied 8.3% so far this year compared with the industry’s growth of 9%.

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We remind investors that AbbVie and Roche (RHHBY - Free Report) jointly develop Venclexta (called Venclyxto in Europe). The companies jointly commercialize the drug in the United States while AbbVie markets it outside the country.

In May 2021, the European Commission approved Venclyxto in combination with hypomethylating agents azacitidine or decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (“AML”), who are ineligible for intensive chemotherapy in Europe. Venclexta is already approved in the United States for a similar indication. It is also approved in both the United States and EU for certain patients with chronic lymphocytic leukemia (“CLL”).

Venclexta/Venclyxto is a key cancer drug in AbbVie’s portfolio. The drug generated revenues of $405 million for AbbVie in the first quarter of 2021, reflecting growth of 24.5% year over year on an operational basis.

AbbVie is also studying Venclyxto/Venclexta to expand the latter’s 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. Potential label expansions in the future should drive sales.

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 five hematologic cancers, has multi-billion-dollar potential. Several studies on Imbruvica are ongoing to evaluate the drug alone or in combination in different patient segments.

AbbVie believes that oncology will be its major growth driver over the next decade.

Zacks Rank & Stock to Consider

AbbVie currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Alexion Pharmaceuticals, Inc. , which has a Zacks Rank #2 (Buy) at present. You can see  the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Alexion’s earnings estimates have been revised 0.1% upward for 2021 and 0.1% upward for 2022 over the past 60 days. The stock has rallied 16.9% year to date.


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