What About the Drug?

Back in 1983, when Dr. John Mendelsohn applied for a National Cancer Institute grant to study growth-factor receptors in tumors, he was flatly rejected. His idea to create antibodies that would find and bind to tumor cells, blocking their ability to recruit the nutrients they need to flourish was considered unproved and risky. "He had a vision going way back that antibodies might have an important role in the treatment of cancer," says Dr. Stuart Kornfeld, one of Mendelsohn's mentors at Washington University in St. Louis, Mo.

Twenty years later, Mendelsohn is president of MD Anderson Cancer Center in Houston, and his cancer-fighting approach remains controversial. When his backers at ImClone sought FDA approval for Mendelsohn's Erbitux cancer drug, the agency declined to consider it. By giving cancer patients Erbitux and chemotherapy together in clinical trials, the FDA said, ImClone made it difficult to determine how much impact Erbitux had.

Most cancer specialists, though, believe that while Erbitux and the science behind its development are radical, both are solid. Erbitux can home in on a protein beacon found on 80% of tumors, making it a promising candidate for treating a range of cancers, from breast to lung to colon. "Nobody has ever questioned the value or the trustworthiness of the science," says Dr. Larry Norton, head of solid tumor oncology at Memorial Sloan-Kettering Cancer Center in New York City.

Ongoing studies described at a recent cancer conference indicate that Erbitux makes chemotherapy more effective. Patients who had not previously responded to chemotherapy benefited when the same chemotherapy drugs were taken with Erbitux. If these results hold up, Erbitux could become a vital part of a multidrug assault on cancer regardless of ImClone's fate. And Mendelsohn may finally see his vision become a reality.