Because regulatory authorities insist that we do development that way, and the investigators, quite rightly, don't want to
be sued for not giving their patient the standard of care, it's almost like we've gotten stuck with having to do studies that
arenreally advancing the science or showing the best way that these drugs should be used. It's very hard to see what we have
to do to earn the right to start changing the standard of care instead of just adding onto it.
CLINTON: Drug development is oriented toward late-stage cancers, but the business opportunity is with early-stage cancers.
Any ideas about how we get from where we are now to where we would like to be?
LACAZE: I'm not certain if anyone has the answer to that because, if we did, everybody would be doing it right now. But FDA is trying
to work with companies, with the Critical Path Initiative, to help companies get through this. Otherwise, you just have to
launch your product as a third-line therapy and gradually develop data and pursue approvals for earlier lines of therapy.
Alison Ayers, group leader, commercial head oncology worldwide marketing, Pfizer
AYERS: The first step is diagnostics. Obviously, with breast cancer we're doing a great job because we have widespread use of mammography,
at least in the United States. But until we have the diagnostics that can identify through a genetic profile if somebody is
predisposed to developing cancer, or until we have better imaging or blood tests perhaps, it's going to be really hard to
pick up those early cancers.
Personally, I think that we're only a few years away from drugs that have the right profile to be used in early-stage patients,
but the point is finding [the patients]. And, of course, it's important for governments to commit to screening because companies
are not going to develop a diagnostic if the governments are not going to pay for screening.
CLINTON: Where are the opportunities today to use targeted therapies to treat cancer patients earlier?
SEELEY: Today, treating patients is much more prescriptive. Many oncologists treat their patients based on ASCO, NCCN, insurance-company
guidelines, and their own internal guidelines.
NAEYMI-RAD: There are some populations, like the very elderly with co-morbid conditions, who simply cannot tolerate—even with the best
supportive care—a cytotoxic regimen. Those patients are not always your average, first-line metastatic patients.
Now that there are a growing number of kinder, gentler biologics available, it is an area open to experimentation. Whereas
physicians would not use an all-biologic therapy for first-line for most of their patients, for patients that just can't take
chemotherapy, they may try it.
AYERS: Right now, the system is set up in such a way that you have to earn the right to move earlier. So you do your study in a
salvage population to earn the right for it to be used in a first-line metastatic population.
Once you've established that, depending on your data, you may earn the confidence of investigators and patients to move into
an adjuvant setting. And when we follow that paradigm, because we had to get five years' survival, we get our adjuvant indication
just about the time when our patent is expiring.
CLINTON: It sounds like a good way for treatment to evolve—but not a good way to grow a business.