Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts tagged ‘tarceva’

AstraZeneca's Gefitinib (Iressa) has had a bit of a chequered history since it's fast track approval by the the Japanese Health Authority in 2002 and the FDA in 2003 for non-small cell lung cancer (NSCLC). However, since the phase III trials did not appear to generate a significant overall survival advantage, it has been available in the US, Canada and Switzerland under strict labelling restrictions based on the ISEL study since 2005.  A patient assistance program is available for suitable patients in the US:

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After the news yesterday about Bayer's sorafenib being rejected by NICE in liver cancer comes another oncology decision, this time a positive one, and good news for AstraZeneca and gefitinib (Iressa).

The new guidance states:

"Gefitinib is recommended as an option for the first-line treatment of people with locally advanced or metastatic non-small-cell lung cancer (NSCLC) if: 

• they test positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation and 

• the manufacturer provides gefitinib at the fixed price agreed under the patient access scheme."

c-MET inhibitors are a class of drug I've been interested in and following for a little while.  All are in early development and most of the big oncology players have one lurking in their pipeline. The concept of blocking c-MET is appealing because of number of studies have shown that activated c-MET mutations may be associated with poorer prognosis and induce resistance, ie an escape route for cancer cells. 

Looking at the pathways we can see MET has a strategic position in the signalling as an upstream receptor, which makes it a good potential target, much in the way EGFR, VEGF have shown proof of concept to date:


Last night many people in the NY-NJ-CT region missed the Oscars beamed from the Academy Awards after an argument over money between CableVision and ABC.  If a Biotech company and their big Pharma partner has a spat, it is rarely as public or has as much impact as TV deals do, but the shock waves can certainly be felt through the investor community every time a high profile predatory shareholder such as Carl Icahn gets their teeth into a biotech such as Genzyme or Biogen IDEC.

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It’s been a bit of a long week on lung cancer articles and while I was planning on talking about something else today, this new article in my database caught my eye:

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Part of the reason is nostalgia – it’s 20 years ago since I finished my doctorate on early detection of preclinical lung disease and while I was interested in the methods of detecting changes in breathing patterns associated with smoking, part of me wished I’d done research on molecular biology at the time rather than applied physiology.

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After writing the first two posts in the series, I was much amused to see this tweet in my Twitter stream from one of buddies:

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When you've been blogging on science, marketing, PR and cancer topics for several years you begin to wonder if it actually beneficial to anyone, so today's post is dedicated to Miguel in Barcelona for making me smile :-).  If you're on Twitter, please do
follow him because he's a great guy and shares a lot of very interesting pharma related links.  Give him some Twitter love!

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Whoa, that was a fascinating news release I saw float through my Twitter stream 2 hours ago:

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As CNBC's Mike Huckman pointed out, the link appeared Twitter before the press release alert dropped in our inboxes.  Nice one, Genentech!

Anyway, after the very negative ODAC hearing last month where only one panel member voted in favour of approval, it seems that OSI and Roche/Genentech have be granted a reprieve and a chance to address any concerns the FDA may have with the data.

Genentech posted the following statement:

Chomping at the bit, like many others today, to hear how the FDA ODAC meeting goes on regarding Tarceva maintenance therapy in lung cancer.

The initial OSI company presentation appeared to go well, but Q&A session did not; the committee clearly had concerns about the statistics.  The SATURN data in adenocarcinoma was not as impressive as hoped, with the overall survival benefit being one extra month as opposed to taking the drug second line after initial chemotherapy failing and then getting 3 months of extra benefit with either Tarceva or docetaxel.  Sometimes waiting and recovering will get you better results.

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