According to biopharmaceutical company ImmunoGen Inc. and its partner, Swiss drug maker Roche AG, the U.S. Food and Drug Administration has decided to award priority review to TDM-1, an experimental therapy against some subtypes of breast cancer.
Priority review means that the FDA will decide whether or not to grant approval to ImmunGen within six months, as opposed to the standard ten months. The date for the decision is now February 26, 2013.
Immunogen CEO Dan Junius:
“We’re very pleased that the FDA has granted Priority Review. This decision underscores the urgent need to have new and more effective treatment options available for patients with this cancer.”
TDM-1 combines Herceptin with an anti-cancer agent for the treatment of patients diagnosed with HER2-positive breast cancer. The companies say that a phase III trial demonstrated that TDM-1 was superior to existing therapies in terms of overall survival.
TDM-1 is the first commercial product for Immunogen and many patients are anxiously awaiting its approval, so much so that some even took part in a protest at the 2012 BIO International convention in Boston, calling for the FDA to act quickly to approve the drug.
In related news, the companies are getting closer to market approval in Europe as well.
Source: Immunogen
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