CLINTON: When did it begin to change?
AYERS: I think it is going to be changing rapidly in the future. In most tumors, the traditional cytotoxic regimen is still the
gold standard—we are increasinly seeing targeted therapies added on.
NAEYMI-RAD: Historians may one day call this period the Early Renaissance in oncology. Never before has the development pipeline been
so full of oncology products. These will inevitably impact the market five, 10 years down the road and have a profound impact
on care. This is probably just the first chapter in what will be a drawn-out epic.
We're seeing a large number of $10-million-plus deals for products that are still in discovery. In oncology, between 2004
and 2005, there was somewhere in the region of 40 to 50 deals. In contrast, the next highest was in CNS at 20 or 25. Cardiovascular
was at 10. So none of these therapeutic areas had as many deals so early in development.
Robert LaCaze, vice president, US oncology marketing, Bristol-Myers Squibb
CLINTON: That speaks to the competition for compounds in the pipeline. But what about the competition between products on
SEELEY: When Taxotere came into a marketplace dominated by Taxol, it changed the equation of competition in oncology.
NAEYMI-RAD: The door policy for oncology has now become a lot tighter. It's become much more expensive and difficult to get into and,
I would argue, much more difficult to sustain. A lot of companies have struggled to maintain their franchise's momentum in
light of some of their key assets going off patent.
Now the pace at which products are coming out has gone up exponentially. Colorectal cancer is one of my favorite examples:
More has happened over the last seven years, with the advent of Camptosar, Eloxatin, Erbitux, Avastin, and the other products
that followed, than in the 20 years before.
AYERS: We have an overabundance of riches in the research pipeline right now. There are three angiogenesis inhibitors on the market,
but there are 40 in clinical development. And at least nine of those are in Phase III trials for breast cancer and nearly
as many for non-small-cell lung cancer.
We're getting to the point of oversaturation. Where previously almost every drug that made it onto the market had some niche,
now we're going to have to differentiate oncology drugs like we do cholesterol-lowering agents. Choosing between them is going
to be really difficult.
LACAZE: Efficacy is always going to be the key driver, but efficacy is going to be the entry. And safety and tolerability will also
continue to be paramount. But drugs will increasingly compete on quality-of-life issues, especially as you move into maintenance
therapies. We see that right now in several disease states.
Sooner Rather Than Later?
CLINTON: Competition is bringing about many new challenges for marketers of cancer therapies. But it seems they are fighting
over the smallest piece of the pie by targeting late-stage patients.
SEELEY: Investigators and companies are sometimes hesitant to move rapidly into the early-stage setting, not the least of significance
because of long-term safety issues that may not have been identified.
The way Taxotere was approved on very early data, and in a fairly broad indication, is very different from the way drugs are
getting approved today in very small niche indications—third-line, fourth-line, for example.
AYERS: Investigators insist that every patient has to have the current standard of care. And IRBs [Institutional Review Boards]
insist on that too. So you have to add your drugs onto the current standard of care. And if we do that, we end up with these
incredibly complex and expensive regimens.