Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘Ibrutinib CLL’

AACR Annual Meeting 2016 BannerOne of the hot topics at the forthcoming 2016 annual meeting of the American Association for Cancer Research (AACR) in New Orleans is likely to be CAR T cell therapy (Twitter: #AACR16).

Several research groups have shown impressive results in acute lymphoblastic leukaemia (ALL), but challenges remain in using adoptive cell therapy to treat other leukemias such as CLL, as we heard from Dr Porter at the recent BMT Tandem meeting. See post: Challenges and Opportunities of CAR T cell therapy in CLL. Perhaps more significantly, there’s a long way to go before CAR T cell therapies hit prime time in solid tumours.

What is fascinating is the pace of scientific research in the field. By the time the first CAR-T cell therapy is FDA approved, the second generation constructs used in them will most likely be obsolete.

This post reviews completely new research, which we’ve not written about before, that I expect we’ll hear more about at AACR, and discusses novel concepts about how to make CAR T cell therapy more effective in both leukemia and solid tumours.  It’s a good pre-AACR preparation for those interested in cancer immunotherapy and the emerging CAR T cell therapy landscape.

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Earlier this month, Janssen/Pharmacyclics announced they had submitted a New Drug Application (NDA) for Food & Drug Administration (FDA) approval of ibrutinib, an oral Bruton’s tyrosine kinase inhibitor (BTK) in chronic lymphocytic leukemia (CLL) for the treatment of patients with a deletion of the short arm of chromosome 17 (del17p). Here’s a link to July 10 press release.

The company have requested Priority review; approval later this year or in early 2014 is highly likely given that the agent has also been designated a Breakthrough Therapy by the FDA.

This is great news for CLL patients!

CLL is an incurable disease. It is the most common leukemia in the United States with 15,500 new diagnoses a year.

Chromosomal abnormalities are fairly common in CLL and predict both time to first treatment and overall survival i.e. how long someone will live. Sadly, those with a 17p deletion have the worst outcome and a poor prognosis.

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It’s exciting times in Chronic Lymphocytic Leukemia (CLL) with a lot of new data in expected at the forthcoming 2013 annual meeting of the American Society of Hematology (#ASH13) in New Orleans.  Several products have received Breakthrough Therapy status from the FDA.

At ASCO 2013, Sally Church (@MaverickNY) interviewed Dr Susan O’Brien who is the Ashbel Smith Professor in the Department of Leukemia at the University of Texas MD Anderson Cancer Center and someone who is making a difference to the lives of CLL patients.

This video was originally published on Pharma Strategy Blog. It’s long (17minutes – took a whole weekend to edit in FCP X) but Dr O’Brien covers a lot of points e.g. IPI-145, what effect does the gamma isoform have in CLL? On ABT-199 she discusses the Tumor Lysis Syndrome seen. Other products discussed include ibrutinib, idelalisib, AV-292 and obinutuzumab.

It’s well worth watching again in the run up to ASH 2013. Subscribers to Premium Content can login in below to view it.

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