As reported in Fierce Biotech and Xconomy (below), Roche reviewed its encouraging clinical results with T-DM1 and filed a BLA with the FDA.
Genentech Seeks FDA Nod for T-DM1.
T-DM1 is the next generation of Roche's Herceptin conjugated to a cytotoxin for the treatment of breast cancer in women who are Her2 positive and have been treatment resistant. T-DM1 is an antibody conjugated drug (ADC) developed with technology coming from a partnership with Immunogen. T-DM1 is xconsidered to have a chance to be another blockbuster in the cancer arsenal.
With an accelerated review, Roche could get marketing clearance in as little as 6 months for treating advanced breast cancer. The drug has performed so well in Phase II trials in shrinking previously treatment resistant tumors that expedited approval is considered a real possibility.
Posted by Bruce Lehr July 7th 2010.
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