tarceva news!!

[RandyW]

Cancer drug Tarceva, made by OSI Pharmaceuticals (OSIP)has had its review period extended by the Food and Drug Administration. The FDA has extended the period for examination due to additional information on the drug supplied by OSIP.

Tarceva is marketed by both OSI and Roche Holding’s Genentech unit. It is approved to treat small cell lung cancer after treatment with chemotherapy fails. Because of this, the drug is considered second-line.

As of Friday, OSI in combination with Genentech announced that by April 18, they expect FDA action to be taken on the drug.

[neilb]

Randy: Thanks for the report. Just to clarify, Tarceva, which is approved for NON-small cell lung cancer (I assume that was just a typo in the release you were quoting) in 2nd (or later)-line use, was rejected by the FDA (by a 12-1 vote) in December as a maintenance drug (to be used immediately after successful first-line treatment), due to an insufficient level of supporting data. OSI and Genentech then submitted more data, and the revised application will be considered for a decision by April. One key point is that Tarceva remains approved for 2nd-line and later NSCLC.--Neil

investor.osip.com/releasedetail.cfm?ReleaseID=438052

[cat127]

Just to further clarify - it was NOT rejected by the FDA. The FDA never released any decision prior to this announcement. It was rejected by their advisory committee, which is not the same as being rejected by the FDA. The FDA is not bound by the decisions of the advisory committee (though as the media often tells us, they don't usually go against the advisory committees) and the advisory committees do not make any regulatory decisions.

[neilb]

Cat: Thanks. That was sloppy of me.--Neil

[cat127]

No prob Neil. I knew you knew, and I'm sure lots here did too. Just wanted to make sure for the folks just starting out on this journey and learning so very much in such a short time.

[jaminkw]

Those of you who take the time to follow these important topics never need to apologize to each other or anyone. Most of us don't know these things and I, for one, am grateful to have this clarified. I'm not considered to be on second line because I didn't fail on Avastin maintenance, I chose to go off it. I am currently on Alimta and was wondering if/when I progress on it, would I go to Tarceva. Apparently not since I have NSCLC.

Thanks to all of you.

Judy in Key West

[neilb]

Judy: Tarceva IS used for NSCLC. In fact, that (and pancreatic cancer) is what it's approved for. Without giving medical advice (which would not be good, since I'm not a doctor), Tarceva would be a major consideration for someone in your situation after Alimta (though hopefully you'll do well on Alimta for years!). You can find informative posts on Tarceva from the doctors at GRACE.

Best,

Neil

[cat127]

Yeah, apparently a "non" was left out of that press release. Which may not seem like a big deal to those not in the lung cancer community, but we know what a difference it does make.

I was looking at Kelly's latest scan reports and she heard me give a little "HA" sort of sound. She looked at me and I noted that the one report listed her as having small cell. Those 3 little letters have a habit of going missing it seems.