Roche reported today that the FDA has granted it (and partner ImmunoGen) a priority review for its breast cancer drug T-DM1. The decision is due by Feb 26th. When approved, T-DM1 will be the second approved ADC on the market. The EMA also accepted Roche's marketing application for the key European market. Phase III results for T-DM1 have been strong and the drug is considered to be a potential blockbuster by many analysts. Peak sales volumes of $5B or greater have been projected upon its approval. See Fierce Biotech.
We only have 4 months (maximum) to wait.
Posted by Bruce Lehr Nov 7th 2012.