On June 11, AbbVie and Roche announced the FDA’s approval of Venclexta (venetoclax) in combination with Rituxan (rituximab) for the second-line treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

The companies also reported an FDA-authorised expansion of the drug’s monotherapy indication, extending its clinical use to all relapsed or refractory CLL or SLL patients. GlobalData believes that Venclexta will continue to earn label expansions as both combination and monotherapy, positioning the drug as an important player in disease management for CLL and other hematological cancers.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Venclexta is a first-in-class inhibitor of BCL-2, a protein with a keystone role in regulating programmed cell death in cancer. For three decades after its initial discovery, BCL-2 was regularly featured on drug developers’ lists of promising but unaddressed cancer targets, particularly for hematological malignancies that rely heavily on dysregulated cell death.

Making progress

Early experimental therapies targeting BCL-2 and related proteins were hampered by side effects, including dose-limiting thrombocytopenia. A turning point came in 2016, when Venclexta was approved by the FDA for the treatment of patients with resistant or refractory CLL. However, the drug’s scope was restricted to patients with the chromosomal defect of 17p deletion, tempering its clinical applications and AbbVie/Roche’s market reach.

The expanded approval of Venclexta came from recent MURANO (NCT02005471) Phase III clinical trial data showing a significant improvement in progression-free survival for relapsed/refractory CLL patients over the standard of care. Venclexta used in combination with Rituxan had a comparable safety profile to Venclexta alone, and achieved an overall response rate of 92%. Venclexta plus Rituxan is the first approved oral chemotherapy-free therapy for CLL that allows patients to discontinue treatment after two years. It is likely that further chemotherapy and chemotherapy-free combination approvals with Venclexta are on the horizon.

Potential CLL competitors

In the CLL space, Venclexta faces competition from Gilead’s Zydelig (idelalisib) as well as from AbbVie’s own CLL blockbuster, Imbruvica (ibrutinib). As such, the drug has been entered into late-stage clinical trials for other indications, including acute myeloid leukemia (AML), multiple myeloma, and mantle-cell lymphoma. Preclinical and early clinical results have highlighted a promising role for Venclexta in AML treatment, earning the drug an FDA Breakthrough Therapy designation in 2017 in combination with cytarabine. Given its distinctive mechanism of action and approval trajectory, GlobalData believes that Venclexta is positioned to become an essential drug as combination or monotherapy for diverse leukemias and lymphomas.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Meanwhile, the drug has been a triumph for translational research as proof of concept for targeted cell death therapeutics in the clinic. As Venclexta gains momentum, more companies are expected to push for clinical development of this drug class. AbbVie will continue to lead the field by growing Venclexta’s indications while simultaneously developing its Phase II drug navitoclax, a dual inhibitor of BCL-2 and related protein BCL-XL, for solid and blood cancers. Similar therapies targeting MCL-1, another BCL-2-related protein, have undergone preclinical validation by Amgen, AstraZeneca, and Servier, and are now in Phase I clinical trials.