Pharm Exec's Brand of the Year award recognizes Roche's oncologic, Avastin, not only for the its clinical merits but for the drug's
larger symbolic importance in demonstrating the sheer staying power of breakthrough innovation. The steady growth in FDA-approved
indications for Avastin is salvation therapy against society's loss of faith in medical progress, expanding the innovation
big tent to show that "first in class" can also mean "further to last."
This honor goes to Avastin for its early success in establishing a new clinical paradigm for cancer treatment, bolstered by
a baseline of six indications in five tumor types, including the drug's initial approval, in February 2004, for advance-stage
colorectal cancer. Two of these—for relapsed glioblastoma and renal/kidney tumors—occurred in the past year. Four other potential
indications, covering early stage colon/rectal cancer as well as cancers of the prostate, ovaries and gastric system, await
the results of Phase III clinical trials to be presented at medical congresses over the next 12 months.
GETTY IMAGES / GARY S CHAPMAN
All told, Roche has 30 separate discovery and development programs underway to capture Avastin's potential against a variety
of metastatic tumors. More importantly, the drug's status as a definitive treatment advance has stimulated complementary strands
of useful research, not only in government and academia but within industry itself. According to William Li of the nonprofit
Angiogenesis Foundation, 10 cancer drugs modeled on Avastin's unique mechanism of action are now on the US market, and another
120 agents are in clinical trials—26 of which are in Phase III. Roche alone has funded some 450 studies to demonstrate the
value of the Avastin franchise to clinicians and patients. Every Big Pharma company with a stake in oncology is focused on
research seeking similarly targeted ways to render cancer dormant by undermining initial tumor growth, slowing relapse after
surgery or stimulating natural immune responses to replace traditional chemotherapy that attacks healthy as well as malignant
cells. Thank Avastin for that.
Avastin is not without controversy, however. Some trials indicate only marginal benefits, particularly when balanced against
side-effects that in rare instances can be fatal. But the latent promise of this new line of therapy has stretched the boundaries
of what is considered an approvable drug for cancer. Advocacy around the lack of other alternatives for breast cancer patients
who fail conventional therapy has persuaded the FDA to allow accelerated approvals on the basis of evidence showing a delay
in the worsening of disease, as opposed to the gold standard of increased survival. While some cancer advocates see this as
lowering the bar on efficacy, others contend it's a win/win. Patients get another chance to fight, while industry retains
an incentive to develop the next innovation. "Even if short-term clinical benefit for a first-in-class like Avastin is modest,"
Temple University pharmacy Professor Albert Wertheimer told Pharm Exec, "It sustains the momentum of research toward better end points linked to survival and—eventually—a cure."