Posts tagged ‘ABT-199’
The challenge of Tumor Lysis Syndrome in Hematology New Product Development
February 20th, 2013
Daedalus
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.
The annual meeting of the American Association for Cancer Research (AACR), held in Chicago earlier this month, is one of the most important meetings of the year for cancer scientists, pharma/biotech drug development and new products professionals.
Bill Sellers, in the AACR plenary session, described how Novartis are using the Cancer Cell Line Encyclopedia (CCLE) in conjunction with the Broad Institute to identify promising new compounds.
As Sally Church, PhD noted on Pharma Strategy Blog in her post on the highlights of AACR 2012:
“What made the meeting exciting for me was the sheer number of new compounds emerging from late preclinical to early phase 1.”
Two of the many promising new drugs in early stages of development were highlighted on Biotech Strategy Blog:
AZD3514 (AstraZeneca), a selective androgen receptor down regulator (SARD) in phase 1 clinical trials for castration resistant prostate cancer (CRPC).
ABT-199 (Abbott), a new Bcl-2 inhibitor (that improves on navitoclax), in phase 1 drug development for chronic lymphocytic leukemia (CLL).
There were many noteworthy posters presented at AACR particularly from young researchers
e.g. “Overcoming resistance to EGFR-tyrosine kinase inhibitor therapy in non-small cell lung cancer” was a poster that suggested the prospect of future drug development targets.
During the high quality poster and oral sessions, we met numerous people including CEOs of baby biotechs, young researchers and clinicians with an interest in translational research, including Laura Strong, Ph.D President & COO of Quintessence Biosciences (@scientre), David Woessner who was presenting his PhD research (@pinfoto) and Philippe Aftimos, MD from Belgium (@aftimosp), all of whom were actively sharing their observations during numerous sessions via Twitter during the conference.
The annual meeting is not just about basic science though, but also drug development strategy and emerging research trends, such as the automation of preclinical drug discovery, as well as the collaboration between academia and Pharma/Biotech in combination clinical trials using two novel compounds from different companies. This last trend, I am pleased to say, has already begun and will hopefully continue apace in the future.
If you were not able to attend AACR, then Sally Church aggregated all the #AACR tweets from the meeting on Pharma Strategy Blog. AACR also have webcasts of some of the sessions available, including some with free access.
We’re already looking forward to AACR 2013 in Washington, DC and the timing of the meeting means it should take place when the renowned Cherry Blossom are in full bloom. Hopefully, this will provide a great opportunity for another Pharma Strategy Blog video!