Re: Accelerated approval minutes - ODAC

[Guest guest]

At 04:50 PM 3/16/2011, Karl wrote:

>See Accelerated Approval (AA) for Oncology Drug Minutes of the meeting:

>http://1.usa.gov/dVkY23 (406 pages.)

Karl, thanks for the link.

These meeting minutes provide a glaring 'how-sausage-is-made' view of

the Oncologic Drug Advisory Committee processes. Although a little

page formatting could convert the 406pages into 100pages of minutes,

the minutes are excessively repetitive. An executive summary would

have added greatly to the value of these minutes.

Dispite the bulk and difficult to read minutes, it seems the

committee agrees that accelerated approval of cancer drugs should be

available for only very rare cancers, with the committee chair

summarizing that notion on Page 337: " DR. WILSON: I think we all

agree that randomized studies are the way to go. I have to say that

I'm a little bit conflicted by this question, because I'm thinking

why is accelerated approval there ........... "

[Wyndham , M.D., Ph.D. (Chair of ODAC), Chief, Lymphoma

Therapeutics Section, National Cancer Institute]

Even the patient advocates at the meeting seem to agree that

single-arm randomized studies for accelerated approval should be for

very rare cancers and randomized studies should be the expectation

for almost all new cancer drug approvals.

e.g. Page 312: " Ms. Mayer: .....I think single-arm trials should be

really reserved for circumstances where there are so few patients and

such an unusual..... " [Musa Mayer, M.S. (Patient Representative) New York]

If such output of ODAC usually reflects what the FDA does in altering

guidelines, then it seems anyone wanting to influence those

guidelines will 'first' have to digest the sausage & sausage-makers

encased in minutes like these, because those committee members

( " sausage-makers " ) may be an important target audience for advocacy

if that advocacy is to have significant impact.

Al Janski

[Guest guest]

Thanks Karl for the inital post and Al for the sausage review.

I waded through the pages .. may have missed some of it, but found it

interesting with an underlying message that was frustrating. (My heart went out

the drug companies that were trying to meet the post-marketing test

requirements.) It seemed clear that accruing for randomized studies was very

difficult and there was a level of FDA " fussiness " that felt a bit antiquated /

archaic.. like all the comments about why didn't the Bexxar study have CT scans

from the local practices, etc. And why did they invite the HIV AIDS expert in

to talk about the successful paradigm for rapid introduction of drugs for that

disease and then revert to the old measures of success? (Randomized studies

etc.) It seemed the rapid approvals for the HIV AIDS drugs came about because of

the viral load " surrogate " measure (replacing PFS and OS as the measure?) CLL

must have a set of surrogates that could likewise be used and thus more rapidly

measure the success of the drug. All in all, it was a depressing read, coming

out of it with a heavy heart thinking, " Why would a drug company go through

these hoops or, more importantly, how can a drug company go through these hoops

as the patient population becomes more sophisticated and selective in selecting

their treatments? Or, are we returning to the dark ages where we can only get

the latest and greatest drugs if we win them in the randomized Phase III

lottery? "

Please tell me I'm wrong. Are we still considered a " rare " cancer and thus our

drugs may still be eligible for accelerated approval?

Lynn

Al Janski says:

......

>

> Dispite the bulk and difficult to read minutes, it seems the

> committee agrees that accelerated approval of cancer drugs should be

> available for only very rare cancerss ...

[Guest guest]

At 02:24 AM 3/18/2011, lynnb65 wrote:

> Are we still considered a " rare " cancer and thus our drugs may

> still be eligible for accelerated approval?

Following my own advice to focus on the perspectives of the ODAC

members as a target for what can be expected, and based solely on the

content of these (disjointed) minutes, I would predict that CLL would

'not' be considered (by the current members as a whole) a

sufficiently rare cancer to qualify for accelerated approval of new CLL drugs.

Encapsulated within the minutes are a variety of secondary

difficulties even if new CLL drugs somehow are allowed (by the FDA)

to enter an accelerated approval path.

There are a few morsels of hope within the minutes. For example,

there is some off-hand discussion of new types of more targeted drugs

that might justify new perspectives about what might be required for

their approval (not necessarily related to accelerated

approval). However, I did not sense much energy from the member

statements for doing the hard work to define how best to alter

regulatory approval processes to reflect the unique characteristics

of such new types of cancer drugs. The members, understandably, seem

to quickly retreat back to the comfort & safety of historical tried &

tested templates for drug approval.

Al Janski