ImClone Starts Approval Process for New Cancer Drug

As expected, ImClone Systems (IMCL Quote) has begun the process of seeking regulatory approval for its experimental cancer drug, IMC-C225.

The New York City-based biotech firm said today that it has initiated a "rolling" application with the Food and Drug Administration. The company wants the FDA to approve the use of IMC-C225 to treat patients suffering from advanced colon cancer. ImClone's drug is used in combination with another chemotherapy drug.

In May, ImClone executives said they expected to file for approval by the end of June. The FDA has given IMC-C225 "fast track" status, which means the agency could issue a decision within six months of the application's completion. ...