Biotech Strategy Blog

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

Posts tagged ‘AP26113 Breakthrough Therapy’

ESMO 2014: Update on the ALK lung cancer market

It’s a while since we discussed ALK+ lung cancer, but with new data coming out at ESMO last week, this is a good time to take stock and see what’s happening with the next generation inhibitors in a post crizotinib (Xalkori) world. These include ceritinib (Zykadia), alectinib and Ariad’s AP26113, which just received Breakthrough Therapy Designation from the FDA.

At ESMO two years ago in Milan, it was quite clear in a dedicated ALK session that these agents not only looked very promising, but were also likely to be fast tracked to market in patients with crizotinib resistance. All are more potent (based on the IC50) than crizotinib, while some target point mutations associated with crizotinib resistance and others have activity in patients with brain metastases, which is one of the common causes of progressive disease with crizotinib.

Today’s post is a long and meaty one – it not only covers data that was presented at the meeting, but also offers a glimpse into the changing ALK landscape.

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Understanding the Breakthrough Therapy Designation – Part 1 of an interview with FDA New Drugs Director John Jenkins

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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