UPDATE 1-FDA warns shorter name of new Roche cancer drug may cause confusion
May 6 (Reuters) - The U.S. Food and Drug Administration warned on Monday that using a shorter name for Roche's new breast cancer drug Kadcyla may lead to the treatment being confused with an older therapy and cause potential harm to patients.
The FDA issued a warning on its website saying that some third-party publications, health information systems and websites were incorrectly using a truncated version of Kadcyla's generic name.
Kadcyla, generically known as ado-trastuzumab emtansine, was being referred to as "trastuzumab emtansine," which can lead to the drug being confused with Roche's blockbuster breast cancer drug Herceptin, generically known as trastuzumab.
The dosing and treatment schedules for Kadcyla and Herceptin are quite different, so confusion between these products could lead to dosing errors and potential harm to patients, the FDA said on its website. ()
Roche said in an email that it had discussed the risk with the FDA during the review of its application.
"To help reduce future risk, the FDA requested that we add a prefix ("ado") to the generic name for Kadcyla."
Roche added that it has also developed a new packaging for Kadcyla to further differentiate it from Herceptin.
Shares of the company were down nearly 1 percent at 233.3 Swiss francs at 1535 GMT.
Health care professionals should use both the brand name Kadcyla and the generic name while communicating medication orders and in computerized order entry systems, the FDA said.
No medication errors related to the confusion between Kadcyla and Herceptin were reported to the FDA since Kadcyla's approval on Feb. 22, the FDA said, adding that medication errors had occurred during the clinical trials testing the drug's safety and efficacy before the approval.
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