Abstract
Introduction
Biological agents are essential tools in cancer treatment, particularly as
antitumor drugs. Unsurprisingly, current R&D in this therapeutic area
therefore focuses on antitumor agents, predominantly MAbs. While the market is
robust-anticancer biologics garnered $9.5 billion in 2005-and expanding, the
future for such high-cost drugs is fraught with competitive and fi nancial
challenges.
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Monoclonal antibodies, generating $7.3 billion in sales in 2005, have been the
most successful class of biological anticancer agents. What does the future
hold for anticancer MAbs? Genentech' s Herceptin (trastuzumab) recently
traversed a clinical path from approval in a small percentage of breast cancer
patients to broader use as an early-stage treatment. How can MAbs and other
biologics expand into new indications? How can agents leverage off-label use
into new approvals and thus vastly expand sales potential? Third-party payers
and patients have expressed concern over the high cost of anticancer
biologics, denying off-label use or forgoing treatment altogether. What impact
will reimbursement issues have on developing agents? Emerging agents may place
pricing pressures on currently marketed antitumor therapies. How can companies
protect the value of current agents? What approaches will manufacturers take
to ensure that new drugs will be embraced in the clinic?
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