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Promising T-DM1 clears PhIII cancer study and marches on to the FDA

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Genentech's closely-watched breast cancer drug T-DM1 passed the goal line on its primary endpoint for significantly improved overall survival among metastatic patients, highlighting its prospects for a near-term FDA approval as parent company Roche ($RHHBY) preps for a filing with the EMA.

The OS results add to the promising Phase III data on progression-free survival when compared to patients taking a combination of lapatinib and Xeloda, and that group will now have the option to be switched to T-DM1. While not surprising, the positive progress of T-DM1 is encouraging analysts to predict a near-certain regulatory approval in the first half of 2013. And the data can only further add to the reputation for antibody-drug conjugates, which have become one of the hottest fields in cancer drug research.

"Based on feedback from our breast cancer oncology consultants, we believe that once approved, T-DM1 will rapidly take over a significant portion of Herceptin's market share in the metastatic setting," writes Cowen's Simos Simeonidis this morning. "If its three planned Phase III trials in the neoadjuvant and adjuvant setting are also successful, we project it will eventually reach Herceptin's level of sales ($5.4B in 2011 WW sales). And since it will probably be priced at a meaningful premium to Herceptin, we think T-DM1 could end up as one of the biggest biotech drugs."

"We are extremely pleased to announce that people treated with trastuzumab emtansine survived significantly longer than those who received a standard option for this aggressive advanced breast cancer," said Hal Barron, M.D., chief medical officer and head of global product development at Roche. "We believe that antibody-drug conjugates have the potential to change the future treatment of cancer, and we look forward to working with regulatory authorities in the hope of bringing another potential treatment option to people with HER2-positive metastatic breast cancer."

Also encouraged by today's progress is ImmunoGen ($IMGN), which provided key ADC technology for the program and stands to earn single-digit royalties following an approval. The FDA had the chance to review T-DM1 after a promising Phase II trial, but summarily rejected the application. Some regulators in the agency may be wishing today that they hadn't been so abrupt. 

- here's the press release

Special Report: T-DM1 – Top 10 Late-Stage Cancer Drugs – 2012

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Related conversation on  Twitter :

  • Good news in cancer drug development: T-DM1 phase succeeds in Phase III breast cancer and proceeds to the FDA.
    Started by @JohnCFierce

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