Roche Holding AG (ROG)’s experimental breast cancer drug T-DM1 delayed the disease worsening in a late-stage patient study, moving the company closer to applying for regulatory approval this year.
Patients who received the drug, which combines Roche’s Herceptin with an older chemotherapy drug, lived “significantly” longer without their disease progressing, compared with those who received a combination of GlaxoSmithKline Plc’s Tykerb and Roche’s Xeloda, the Basel, Switzerland-based company said in a statement today. The trial hasn’t been running long enough to show whether the drug also extended the women’s lives, Roche said.
Roche, which gained Herceptin with its $46.8 billion purchase of Genentech Inc. in 2009, is developing T-DM1 with technology it licensed from Waltham, Massachusetts-based ImmunoGen Inc. (IMGN:US) Roche said it plans to apply for regulatory approval for T-DM1, also known as trastuzumab emtansine, in Europe and the U.S. this year.
“This lends further credibility to Roche’s ability to protect and increase its breast cancer revenues despite the likely appearance of biosimilar Herceptin,” analysts led by Mark Purcell at Barclays Capital wrote in a note today.
T-DM1 is a so-called “armed antibody” that combines of Roche’s Herceptin with DM1, which is derived from an old chemotherapy medicine called maytansine. That drug was found to be too toxic for patients in clinical trials two decades ago. ImmunoGen’s technology enabled chemists to fuse DM1 to Herceptin in such a way that it isn’t activated until Herceptin shepherds it directly to the cancer cell.
The U.S. Food and Drug Administration rejected a request in 2010 to accelerate the regulatory process.
About 1.4 million women are newly diagnosed with breast cancer every year and almost 460,000 die, making it the biggest cancer killer among women, according to the International Agency for Research on Cancer in Lyon, France.
About 25 percent of cases are distinguished by a protein called HER2 on the surface of the cancer cells that causes them to multiply more quickly. Herceptin, which generated 5.3 billion Swiss francs ($5.9 billion) in sales last year, latches on to HER2, interfering with it without killing the cell.
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