ImmunoGen (NASDAQ:IMGN) said today that Roche unit Genentech has received a letter from the Food and Drug Administration denying the company accelerated approval for trastuzmab-DM1.
The drug is a breast cancer treatment combining ImmunoGen and Genentech technology.
A Phase II study showed the treatment shrank tumors in one-third of women with advanced HER2-positive breast cancer, who had received an average of seven prior medicines.
The FDA said it did not meet criteria for accelerated approval because all available treatments choices had not bee exhausted in the patients studied.
Genentech said it will continue to test the treatment to submit for approval at a later date.
ImmunoGen said it is planning updated guidance.
Also today, the European Medicines Agency said it is looking into potential sleep disorders related to GlaxoSmithKline’s (NYSE:GSK) flue vaccine.
The swine flu vaccine, in use for nearly a year, has been given to more than 30 million people in Europe.
The regulator will investigate whether reports of cases of narcolepsy are related to the vaccine.
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