May 6 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
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
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.