Biotech Strategy Blog

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

Posts tagged ‘GA101 CLL’

The FDA approval earlier this week of ibrutinib (Imbruvica) for the treatment of mantle cell lymphoma (MCL), and the recent approval of GA101 / obinutuzumab (Gazyva), for previously untreated chronic lymphocytic leukemia (CLL) is good news for patients.

The forthcoming annual meeting of the American Society of Hematology (ASH) in New Orleans (Dec 7 – 10, 2013) is set to be an exciting event with the launch of new products to treat blood cancers.

Both ibrutinib in MCL and obinutuzumab were granted “breakthrough therapy” designation (BTD) from the FDA. Over the past several months I have been researching what a BTD may mean for cancer drug development.

The catchy “breakthrough” title has given companies and the FDA a noticeable bonanza of good PR, but there’s been a paucity of critical analysis by the media. I have yet to see a convincing argument that that there was a compelling need for a new approval pathway for cancer drugs, or that innovative and breakthrough cancer drugs such as imatinib (Glivec/Gleevec) and crizotinib (Xalkori) could have got to market any faster.

One of the key FDA decision makers is John K. Jenkins, MD, Director, Office of New Drugs in the Center for Drug Evaluation and Research (CDER); he’s Richard Pazdur’s boss. I had the privilege to conduct a phone interview with him over the summer.

In my first post from this interview, subscribers to Premium Content will obtain Dr Jenkins’ perspective on what constitutes a breakthrough? If you are an investor you want to try and predict what may be a “breakthrough” before it becomes one…

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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 – and 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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THE data of the 2013 annual meeting of the American Society of Clinical Oncology (ASCO) that starts later this week in Chicago is expected to be the early clinical trial results for new breakthrough immunotherapies that target PD-1/PD-L1.

However, I’m also excited about the data being presented for the treatment of Chronic Lymphocytic Leukemia (CLL), a disease that kills 75,000 people a year around the world. ASCO typically does not have a strong focus on hematology and blood cancers, so it’s a reflection of the clinical significance of the data that it’s a hot topic at the meeting.

Several companies are in the race to bring promising new CLL drugs to market, and have presentations in Chicago.

Earlier this year, the FDA gave it’s new Breakthrough Designation to two CLL new products: ibrutinib, a bruton’s tyrosine kinase inhibitor from Pharmacyclics and obinutuzumab, an anti-CD20 monoclonal antibody from Roche Glycart. The breakthrough therapy designation recognizes the potential of these drugs to change the standard of care in CLL and meet unmet medical needs.

In many ways the changing CLL landscape reminds me of where prostate cancer was a few years ago just before new treatments such as enzalutamide and abiraterone came to market.

If you haven’t already done so I encourage you to watch the ASCO 2013 preview video from Sally Church (@MaverickNY) in which she highlights several of the key CLL oral presentations and posters. Update Sept 18: this video is now available on the Premium Content Video page.

A few of the CLL new products I’ll be looking out for at ASCO 2013 include:

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