Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts tagged ‘FDA’

Finally, we have a result from the public hearing in Washington DC on whether Avastin is a safe and effective drug in first line treatment of metastatic breast cancer after the Oncology Drugs Advisory Committee (ODAC) voted 6-0 against on all three questions (was Avastin effective, safe and should the indication continue to be upheld).

An overwhelming victory for CDER’s case rather than Genentech/Roche’s.

For those of you wondering whether there was any wriggle room for manoeuvre, take a look at the data for yourselves from the original ODAC meeting last year when the FDA reviewed it.  I put together the response rates and survival curves from the RIBBON1 and AVADO trials at the time, based on the publicly available data on the FDA site for all to see.


Abiraterone (Zytiga)This afternoon the FDA approved Ortho Biotech’s abiraterone acetate (Zytiga) in combination with prednisone for the treatment of castrate resistant prostate cancer in patients who have received prior chemotherapy with docetaxel.

Abiraterone was filed on December 20th, 2010 and received fast track designation, so the FDA approval comes 2 months ahead of the expected PDUFA date of June 20th.

It represents another exciting advance for this disease after what Dr Bernard Tombal described as a “Grand Cru” year for prostate cancer in 2010 following the successive launches of cabazitaxel (Jevtana), sipuleucel-T (Provenge) and denosumab (Xgeva), the first since docetaxel (Taxotere) was approved back in 2006 for chemotherapy naive metastatic disease.


There is a provocative article in this week’s New England Journal of Medicine asking whether the accelerated approval process should be used for more cancer drugs:

“The striking results of recent phase 1 trials of targeted cancer drugs have provoked serious discussion about shortening the road to drug approval.”

The main thrust of the argument was that it takes on average seven years from entering human trials to approval if phase III trials are included in the oncology drug development process.

“Of the 23 oncologic drugs given accelerated approval between 1993 and 2008, two were ultimately withdrawn from the U.S. market — gemtuzumab because of toxicity and gefitinib because of lack of efficacy.”


The current Nature Reviews Drug Discovery has a short analysis of last year’s FDA approvals for new molecular entities (NME) and biologics:

“The US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) approved 15 new molecular entities and 6 new biologics in 2010. The total of 21 new products falls below the 25 approved in 2009 and the 24 in 2008.”

Here’s a graphic of the overall trend since 1996:

2010 FDA drug approvals

Source: Nature Reviews Drug Discovery

You can see that for drugs, the trend has been downwards since 1996, although the last few years have been fairly stable. The biologics, while only a small proportion of the total have been steady.

Well, the long awaited decision by the FDA on bevacizumab (Avastin) in breast cancer has finally been published and is probably the least surprising decision by the agency in 2010:

“The Office of New Drugs (OND) recommends withdrawing approval of the breast cancer indication for bevacizumab (Avastin).  This indication was approved on February 22, 2008, under accelerated approval provisions for use in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer.

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Today I will be out of the office at client meetings, but many of you will be wondering what will happen at the FDA ODAC briefing meeting, which will be discussing the bevacizumab (Avastin) data in breast cancer this morning. You can take a look at the briefing documents here.


Avastin was approved to much fanfare because it was basically shown to shrink tumours quite dramatically and the early magnitude of the PFS data suggested benefit in favour of adding Avastin to chemotherapy.  According to the FDA, full approval would be thus debated once the final survival data were available:


This was the title of a fascinating article I saw on Twitter a few minutes ago, courtesy of the American Association of Cancer Research (AACR).  They are providing access to the paper free of charge to the public using this link.  If you are on Twitter and interested in cancer related research, do follow them and keep track of the hot news items as they share quite a few important articles on translational research.  Of all the medical associations I've come across in social media, they are also very helpful and responsive to enquiries.

This morning I received the usual hodge podge of alert emails, which I only just got round to checking and nearly fell off my chair when clicking through to one from the FDA that brought me up with a start:

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There's been a lot of news out there lately about obesity and diabetes, as well as the excitement of Dendreon's new vaccine for prostate cancer, Provenge, which was approved last Thursday to much fanfare. 

It's therefore a little shocking to see the FDA's initial safety analysis of hormone therapies, which have been pretty much the bedrock of treatment for early stage prostate cancer for many years, including several are now available as generics:

Today's post is going to be relatively short as I'm knee deep (literally) reviewing poster handouts from the recent AACR meeting, but while reading translational medicine data I came across a poster on sipuleucel-T basically explaining that it engages the immune system and activates or stimulates priming of T-cells in asymptomatic disease.  

Like many out there I'm quietly wondering what will happen tomorrow with Dendreon's PDUFA date due on Saturday May 1st.  We can reasonably assume a response on sipuleucel-T (Provenge) might be forthcoming on either Friday or Monday.


Last month at the ASCO GI Symposium, Keryx and Aeterna Zentaris reported statistically significant benefit in survival from updated results of a randomized, double-blind, placebo-controlled phase II study of KRX-0401 (perifosine) for the treatment of advanced metastatic colorectal cancer. 

The study was based on 35 evaluable, but heavily pre-treated patients, with relapsed or refractory metastatic colon cancer were randomized to receive capecitabine (Xeloda) from Roche at 825 mg/m2 BID on days 1 – 14 every 21 days plus either perifosine (P-CAP) or placebo at 50 mg daily (CAP).

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