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AbbVie's (ABBV) Venclyxto Gets EU Nod for First-Line AML

Zacks Equity Research
·4-min read

AbbVie ABBV and partner Roche RHHBY announced that the European Commission has granted approval to their cancer drug, Venclyxto as a combination therapy for acute myeloid leukemia (AML). With the latest approval, Venclyxto in combination with hypomethylating agents, azacitidine or decitabine, can be used for the treatment of adult patients with newly diagnosed AML who are ineligible for intensive chemotherapy in Europe

The approval was based on data from the phase III VIALE-A study and phase Ib M14-358 study. Data from the VIALE-A study showed that a combination regimen of Venclexta plus azacytidine led to statistically significant improvement in overall survival (OS) compared to azacytidine alone. Data from the M14-358 study demonstrated that patients treated with Venclyxto plus azacitidine or decitabine achieved high remission rates.

AbbVie’s stock has risen 6.9% this year so far compared with an increase of 7.4% for the industry.

The approval was expected as last month the European Committee for Medicinal Products for Human Use (CHMP) had given a positive opinion recommending approval of Venclyxto for the expanded use. Venclexta (Venclyxto’s brand name in United States) is already approved in the United States for a similar indication. Meanwhile, it is approved in both the United States and EU for certain patients with chronic lymphocytic leukaemia (CLL).

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AbbVie and Roche jointly develop Venclyxto (called Venclexta in United States). The companies jointly commercialize the drug in the United States while AbbVie markets it outside the United States. Venclexta/Venclyxto is a key cancer drug in AbbVie’s portfolio. Label expansion approvals in the past couple of years have expanded the eligible patient population of Venclexta significantly, which is boosting sales from the drug. Venclexta 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 label to address the broader relapsed/refractory chronic lymphocytic leukemia (CLL) patient population, expand into earlier lines of therapy, and broaden into other hematologic malignancies like multiple myeloma and AML.

AbbVie expects to release data from a phase III study on Venclexta in myelodysplastic syndrome or MDS and combination data for Imbruvica and Venclexta in previously treated mantle cell lymphoma (MCL) and frontline chronic lymphocytic leukemia in 2021.

Another important cancer drug in AbbVie’s portfolio is Imbruvica,which it markets in partnership with J&J JNJ. 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 10 years.

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

A better-ranked stock in the healthcare sector is BioNTech BNTX, which has a Zacks Rank of 1.

BioNTech’s earnings estimates have risen from $10.91 per share to $29.44 per share for 2021 and from $7.34 per share to $21.34 per share for 2022 in the past 60 days. The stock is up 142.5% this year so far.

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