Genentech, a member of the Roche Group (RHHBY.PK), said Friday that the U.S. Food and Drug Administration has approved Kadcyla for the treatment of people with HER2-positive metastatic breast cancer who have received prior treatment with Herceptin and a taxane chemotherapy.
Kadcyla is the first FDA-approved antibody-drug conjugate for treating HER2-positive metastatic breast cancer, an aggressive form of the disease.
Kadcyla combines the mechanisms of action of both antibody, trastuzumab, and the chemotherapy, DM1.
The drug will be launched in the United States within two weeks, Genentech said.
The FDA approval of Kadcyla was based on results from the EMILIA study, which compared Kadcyla alone to lapatinib in combination with Xeloda in 991 people with HER2-positive locally advanced breast cancer who had previously been treated with Herceptin and a taxane chemotherapy.
The study met both co-primary efficacy endpoints of overall survival and progression-free survival. People who received Kadcyla lived a median of 5.8 months longer than those who received the combination of lapatinib and Xeloda, the standard of care in this setting.
Kadcyla was reviewed under the FDA's priority review program, which provides for an expedited six-month review of drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.
Kadcyla's label will contain a boxed warning alerting patients and health care professionals that the drug can cause liver toxicity, heart toxicity and death.
Biotechnology firm ImmunoGen, Inc. (IMGN) said the FDA approval of Kadcyla triggers a $10.5 million milestone payment to the company. ImmunoGen also earns royalties on commercial sales of Kadcyla.
Genentech licensed exclusive rights to use ImmunoGen 's maytansinoid TAP technology in 2000 to develop anticancer products targeting HER2. In 2006, Genentech advanced the compound that became known as Kadcyla into clinical testing.
RHHBY.PK is currently trading at $56.85, up 51 cents. IMGN is currently trading at $14.68, up 38 cents or 2.66%.
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