Roche Cancer Drug Does Not Receive FDA Approval
Swiss drugmaker Roche took a blow this past Friday after the U.S. FDA denied the company’s request for accelerated approval regarding trastuzumab-DM1, or T-DM1. The drug, according to Reuters, “comprises ImmunoGen’s DM1 cancer-cell-killing agent linked to the HER2-targeting antibody trastuzumab, or Herceptin,” as a means of combating cancer. The FDA’s decision will now setback the drug, which Roche hoped to gain approval for this year, to a 2012 resubmission date.
T-DM1 was found to reduce the size of tumors in one third of the women with advanced breast cancer tested during drug trials. In reaction to news of the the FDA’s refuse-to-file letter, Vontobel analyst Andrew Weiss stated, “The impact to (Roche) earnings is marginal. However, the news is disappointing from a sentiment point of view.”
-Michael B. Sauter
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