Phil,
Once in a blue moon FDA does approve a drug in expedient fashion; Xtandi, 3 months early. Will T-DM1 be a repeat performance? Emilia's results seen with PFS and OS end-points would make this a likely candidate. In this case approval would be for 2nd line Mbc.
http://www.cancernetwork.com/prostat.../10165/2099887