Genasense/oblimerson

[Guest guest]

Genta was just denied FDA approval again today, though I had read that

results presented in June 08 demonstrated significant survival

differences between a genasense arm and one without.

Does anyone know more about why the results, which sound promising, are

not sufficient for the FDA?

Thanks, Helene

[Guest guest]

Helene - it has been a long struggle - some of us have tried to support Genta, incl. many docs. Genta hoped they had it this time. I have not seen the refusal yet. Perhaps the percentages are not adequate for FDA. Administration of the drug is also a complicated process. Stay in touch with ALL of your friends: update your AIM, Bebo, Facebook, and MySpace pages with just one click. The NEW AOL.com.

[Guest guest]

Hi Helene,

I'm not sure of the reason for the FDA refusal this time. Initially, I

think it was denied by FDA because it was a subset analysis (evaluation

of part of the study population, not the entire). - There were also

non-trival toxicities ... including more tx-related deaths ... in the

genesense arm.

At the time, as an observer of the ODAC meeting, I was concerned about

the chosen comparator. As I recall it was FC vs. FC+G, which begs the

question, how does FC+G compare with FC+Rituxan? How commonly is FC

used without R? to treat CLL?

Here's the news item today, which does not provide the reasons FDA gave

for the denial: http://www.medadnews.com/News/index.cfm?articleid=589532

Anyhow, over time, I've come to realize that FDA does not decline on

approvals without reason. However, the sponsors many times do not to

disclose the reasons to the public. Hopefully, this time, they will

share the letter of refusal in its entirety.

~ Karl

>

> Genta was just denied FDA approval again today, though I had read

that

> results presented in June 08 demonstrated significant survival

> differences between a genasense arm and one without.

>

> Does anyone know more about why the results, which sound promising,

are

> not sufficient for the FDA?

>

> Thanks, Helene

>

[Guest guest]

Karl,

Thanks. Perhaps there will be some informal discussion at ASH that we

will hear about.

The Bendamustine trial (that was accepted) was against chlorambucil.

I wish full studies and reasons for denial or approval were mandatory

for release with the FDA.

Your answer at least helped makes sense of the first refusal.

Thanks, Helene

[Guest guest]

Hi Helene,

I'm confident about my impression with FDA's concern with subset

analysis - in the initial review, and agree. You have to specify the

endpoint up front, not after the fact, because by chance you will see

relationships between favorable outcomes and something else (even

zodiac signs) and ... merely associations, not necessarily causal.

Regarding the comparator, that's just a concern that popped into my

head, not something I read or that is necessarily what FDA is concerned

about. By the way, with the B versus C study you cite there's a an

apples and oranges aspect to it, as B has higher toxicities than C.

That was brought up at the L & M conference by experts.

~ Karl

>

> Karl,

>

> Thanks. Perhaps there will be some informal discussion at ASH that we

> will hear about.

>

> The Bendamustine trial (that was accepted) was against chlorambucil.

>

> I wish full studies and reasons for denial or approval were mandatory

> for release with the FDA.

>

> Your answer at least helped makes sense of the first refusal.

>

> Thanks, Helene

>