Replies to post #102718 on Biotech Values

[BTH]

I don't agree. I think the FDA really doesn't have any rhyme or reason as to how, why, or when they approve something. It's a crapshoot any time you're dealing with the FDA. They have surprisingly approved some drugs that NO ONE ever expected would be approved (for what reason, who knows), and others, like this, they delay (like Provenge which showed clear evidence of efficacy).


A good overview:

http://www.pharmastrategyblog.com/2010/08/fda-rejects-the-roche-immunogen-t-dm1-accelerated-approval-filing.html

[bladerunner1717]

Roche/IMGN got blindsided by the FDA




Looking at the available clinical trials for T-DM1, this one looks most likely as 100 patients were required and the inclusion criteria stated:

HER2-positive disease
Metastatic breast cancer
Disease progression on the last chemotherapy regimen received in the metastatic setting
Prior treatment with an anthracycline, trastuzumab, a taxane, lapatinib, and capecitabine in the neoadjuvant, adjuvant, locally advanced, or metastatic setting and prior treatment with at least two lines of therapy (a line of therapy can be a combination of two agents or single-agent chemotherapy) in the metastatic setting
At least two lines of anti-HER2 therapy must have been given in the metastatic setting as monotherapy or combined with chemotherapy or hormonal therapy. The HER2-targeted agent can include trastuzumab, lapatinib, or an investigational agent with HER2-inhibitory activity.
There are only two approved treatments for HER2-positive breast cancer, trastuzumab and lapatinib, plus others in clinical trials, eg pertuzumab, which was also allowed as one of the prior therapies. All patients appear to have been refractory to at least two of these drugs, most likely trastuzumab and lapatinib.

The prior chemotherapies included anthracyclines, taxanes and capecitabine, which is quite heavy pre-treatment and includes all of the considered standards of care for several lines of therapy. Indeed, the results of the trial presented at the San Antonio Breast Cancer Symposium last December showed that the average number of prior treatments in the metastatic setting was 7.

I disagree with your second sentence. In this instance, the FDA is simply applying the accelerated approval regs as they are written.

It seems to me, Dew, that the FDA was unbelievably nit-picky in the application of their accelerated approval regs. I mean SEVEN (on average) prior treatments in the metastatic setting; what the hell else can the FDA possibly want? It seems the FDA had it out for Roche on this one. Too bad for the women suffering from this terrible disease.


Bladerunner

[AlpineBV_Miller]

Dew -

I'm interested in hearing what Tx you think Roche missed in the P2 trial. Patients had to have failed Herceptin, Tarceva, an anthracycline, taxanes, and capecitabine. Of the 120 pts in the trial, all met these criteria save one person who did not have a taxane. The emdian number of therapies for M+ disease was 7, the median number of all BCa therapies was 8.

The FDA seemed to indicate that Roche missed some non-targeted therapy. I'd be interested to hear what you think that therapy(ies) might be.