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FDA Approves Roche's Kadcyla For Late-Stage Breast Cancer

 February 22, 2013 11:08 AM

(By Balachander) The U.S. Food and Drug Administration (FDA) has approved Roche Holding AG's Kadcyla, a treatment for HER2-positive metastatic breast cancer.

Roche's Genentech licenses technology for Kadcyla under an agreement with Immunogen Inc. (NASDAQ: IMGN), which will receive a $10.5 million milestone payment following the FDA approval.

Kadcyla is the fourth medicine from Genentech to receive clearance from the U.S. health regulators for people with advanced cancers within the past two years.

Kadcyla works by connecting trastuzumab - another anti-HER2 therapy - to a drug called DM1 that interferes with cancer cell growth, the FDA said.

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The FDA said "Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival. It is the fourth approved drug that targets the HER2 protein."

The drug could generate annual peak sales of $1.9 billion, Reuters reported quoting analysts at Jefferies.

Breast cancer is the second leading cause of cancer-related death among women. An estimated 232,340 women will be diagnosed with breast cancer, and 39,620 will die from the disease in 2013, according to the National Cancer Institute. Around 20 percent of breast cancers have increased amounts of the HER2 protein.

Kadcyla is being approved with a boxed Warning that the drug can cause liver toxicity, heart toxicity and death. The drug can also cause severe life-threatening birth defects.

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The most common side effects reported in patients treated with Kadcyla were nausea, fatigue, pain in the muscles or joints, low levels of platelets in the blood, increased levels of liver enzymes, headache, and constipation.

Immunogen said its TAP technology uses a tumor-targeting monoclonal antibody to deliver one of its highly potent cancer-killing agents specifically to tumor cells.

IMGN shares jumped 4.62 percent to trade at $14.96 on Friday.

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