FDA Approves ImClone Systems Colon Cancer Medication Erbitux
FDA on Thursday approved ImClone Systems' colorectal cancer drug Erbitux, the Washington Post reports (Gillis/Brubaker, Washington Post, 2/13). Last August, ImClone reapplied for accelerated FDA approval of Erbitux after the agency in December 2001 decided not to review the initial application over concerns about problems in clinical trials of the medication. FDA approved Erbitux for patients who no longer benefit from chemotherapy or who cannot tolerate common chemotherapy drugs (Pollack, New York Times, 2/13). The agency said that in combination with another chemotherapy treatment, Erbitux was shown to reduce the size of tumors in almost 23% of patients and to slow tumor growth rate by about four months. On its own, Erbitux shrank tumors for nearly 11% of patients and delayed tumor growth by 1.5 months, according to FDA. Shrinking tumors could help alleviate pain or allow the removal of previously inoperable tumors, according to Daniel Laheru, a Kimmel Cancer Center oncologist (Szabo, USA Today, 2/13). According to the Post, Erbitux has not been shown to extend patients lives, but clinical tests are underway (Washington Post, 2/13). Nearly 25% of patients will not be eligible for the drug because their tumors lack the molecule -- called epidermal growth factor receptor, which causes cancer cells to grow -- that Erbitux blocks, the Times reports (New York Times, 2/13). FDA said that Erbitux's most common side effect is a rash, and it can also cause some "serious side effects," including low blood pressure and difficulty breathing, mostly during the first treatment (Hovey, Wall Street Journal, 2/13). According to researchers, some patients also had severe allergic reactions to the drug (USA Today, 2/13). Andrew Bodnar, senior vice president of Bristol-Myers Squibb, which will market the drug in the United States, said that Erbitux will be available within about two weeks. The price of the drug has not been determined, but some cancer specialists predict that the cost could reach $30,000 per year per patient, the Journal reports (Wall Street Journal, 2/13). According to the New York Daily News, analysts estimate that sales for the drug could reach $250 million by 2005 and eventually top $1 billion (Dillon, New York Daily News, 2/13).
ImClone CEO Daniel Lynch said, "There are a lot of people who worked very hard to make this happen. They know the benefits they will be providing to patients who need this drug" (Washington Post, 2/13). Frank Burroughs, the president of the Abigail Alliance for Better Access to Developmental Drugs, said in a statement on Thursday, "Sufficient evidence of safety and efficacy existed more than two years ago to justify making Erbitux available to dying patients with no remaining treatment options, the same indication FDA approved today," adding, "Tens of thousands of colon cancer patients waited and died." However, Katen Weiss, who supervised the drug's reviewers at FDA, said that the delay did not cause "unnecessary deaths" because "all these treatments for advanced cancer don't cure people," noting that Erbitux only "shrinks tumors and delays their growth," the Times reports (New York Times, 2/13). Dr. Ronald Blum, the director of the cancer center at New York's Beth-Israel Medical Center, said, "We hope for miracle drugs but the reality is the way we make improvements in cancer is incremental." He added, "Erbitux's incremental advance is important" (AP/Boston Globe, 2/13). NPR's "All Things Considered" Thursday reported on the approval. The segment includes comments from Dr. Mace Rothenberg, a professor of medicine at Vanderbilt University, and Bryan Rye, an analyst with investment firm Janney Montgomery Scott (Prakash, "All Things Considered," NPR, 2/12). The complete segment is available online in RealPlayer.This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.