EC Grants Conditional Approval for AbbVie’s Venclyxto for CLL

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

ABBVIE said the European Commission granted conditional marketing authorization for Venclyxto (venetoclax) monotherapy for the treatment of chronic lymphocytic leukaemia in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor; and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.

The EC approved Venclyxto as a first-in-class, oral, once-daily medicine that selectively inhibits the function of the BCL-2 protein.BCL-2 prevents the natural death of cells, including CLL cells.

Venclyxto is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the U.S. and by AbbVie outside of the U.S.

The 17p deletion, a genomic alteration in which a part of chromosome 17 is absent, is found in 3 to 10 percent of previously untreated CLL cases and up to 30 to 50 percent of relapsed or refractory CLL cases.A TP53 mutation occurs in 8 to 15 percent of patients at first-line treatment and up to 35 to 50 percent of cases in refractory CLL. Those with the 17p deletion or TP53 mutations often have a particularly poor prognosisand a median life expectancy of less than two to three years with current standard-of-care regimens.

Conditional marketing authorization is granted to medicines that address an unmet medical need, where the benefit of its immediate availability to patients outweighs the risk of limited data availability, and where comprehensive data will be provided.

In April 2016, FDA granted accelerated approval of Venclexta (venetoclax) tablets for the treatment of patients with CLL with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.

The FDA approved this indication under accelerated approval based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

YOU MAY BE INTERESTED IN

For nearly 25 years, business executive Lou Weisbach and urologist Richard J. Boxer have argued that finding the money to finance the cures for devastating diseases is not as difficult as it appears. To start finding the cures, the U.S. Department of the Treasury needs to issue some bonds—$750 billion worth. Next, you hire CEOs—one...

There is general agreement that the United States spends too much on health care, especially on pharmaceuticals.  But what we spend on drugs is not simply a function of price. If eggs double in price, people can simply cut the number of eggs they eat in half.  Simply stated, cost is the product of (price per unit times the number of units purchased). 
What did President Richard M. Nixon and Senator Edward M. Kennedy have in common? They each played a pivotal role in the passage of the National Cancer Act signed by Nixon on Dec. 23, 1971. The NCA established the National Cancer Program authorizing the initial investment in the NCI-designated Cancer Centers Program. 
When I first proposed targeting PCNA (proliferating cell nuclear antigen) as a therapeutic approach, the response I got was: “No one will ever make a drug against PCNA. It’s undruggable.” The protein lacks enzymatic activity, has a disordered region, and binds to over 200 other proteins within the cell. From a traditional drug development perspective, these characteristics made PCNA an impossible target.

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login