The challenge of Tumor Lysis Syndrome in Hematology New Product Development

Tumor Lysis Syndrome (TLS) has been in the news recently as a result of two patient deaths in a chronic lymphocytic leukemia (CLL) clinical trial with AbbVie’s ABT-199, a novel BCL-2 inhibitor in early stages of development.

What is TLS and why is this important in cancer research was subsequently analyzed by Icarus Consultants hematology industry expert, Sally Church, PhD on Pharma Strategy Blog.

Sally notes in her post, “we don’t yet know whether the effect in ABT-199 is a dose-schedule issue or a compound structure issue (especially given the reformulation from the original navitoclax issue).

It’s a major setback to AbbVie ($ABBV) when the company was poised to start a phase 3 clinical trial with ABT-199 in CLL.

AbbVie will have to convince doctors that careful dose scheduling can solve the problem of a drug that may be too potent for the body to handle.  Further deaths due to TLS could easily stop the development of this compound.

The setback to ABT-199 is, however, good news for ibrutinib that along with ABT-199 is in a race to market in CLL.

On February 12, 2013, ibrutinib received “breakthrough designation” from the FDA for the treatment of mantle cell lymphoma (MCL) and Waldenstrom’s macroglobulinemia.

Breakthrough designation means that a drug can be approved on the basis of early clinical data.  Depending on when filing takes place, FDA approval of ibrutinib in MCL could be forthcoming later this year.

We expect to be producing a report on the CLL new products in development soon. This will cover some of the challenges and issues companies are facing.  If you haven’t already done so, please sign up below if you would like to receive news alerts and be the first to know when reports are available.


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