Federal regulators have ruled that a potential breast cancer treatment from ImmunoGen, of Waltham, Mass., failed to meet the standard for accelerated approval, The Associated Press reports.
The company said its financial guidance for fiscal 2011 is no longer applicable and shares tumbled 17 percent in premarket trading.
The Food and Drug Administration ruled that all available treatment choices for metastatic breast cancer had not been exhausted in the study population, the company said.
The agency reviews a limited number of drugs for accelerated approval status, usually for limited release, to treat serious illnesses with few or no other options.
ImmunoGen has been testing the drug T-DM1 with a unit of Swiss drug developer Roche. Last month, the companies submitted a biologic license application seeking accelerated approval.
The application was based on a mid-stage study that showed T-DM1 reduced tumors in some women with a form of advanced breast cancer who had received, on average, seven prior medicines.
But Genentech received a "refuse to file" letter from the FDA, ImmunoGen said.
T-DM1 is composed of the breast cancer drug trastuzumab, which is marketed as Herceptin by Genentech, and a cell-killing agent developed by ImmunoGen.
Genentech will continue its late-stage trial of the potential treatment and expects to submit a new application in mid 2012, according to ImmunoGen.