The Topic of Cancer - Pharmaceutical Executive


The Topic of Cancer
What will tomorrow's cancer commercialization model really look like? We asked four heavyweights from the world of oncology what they thought.

Pharmaceutical Executive

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?

Alison Ayers, group leader, commercial head oncology worldwide marketing, Pfizer
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.

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.


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