FDA approves T-DM1 for metastatic breast cancer
The fourth approved drug that targets the HER2 protein
The USA Food and Drug Administration (FDA) approved on 22 February 2013 antibody-drug conjugate, Kadcyla (ado-trastuzumab emtansine or T-DM1), a new therapy for patients with HER2-positive, metastatic breast cancer. Kadcyla is intended for patients who were previously treated with trastuzumab, another anti-HER2 therapy, and taxanes.
HER2 is a protein involved in normal cell growth. It is found in increased amounts on some types of cancer cells (HER2-positive), including some breast cancers. In these HER2-positive breast cancers, the increased amount of the HER2 protein contributes to cancer cell growth and survival.
“Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth,” said Dr Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Kadcyla delivers the drug to the cancer site to shrink the tumour, slow disease progression and prolong survival. It is the fourth approved drug that targets the HER2 protein.” Other FDA-approved drugs used to treat HER2-positive breast cancer include trastuzumab (1998), lapatinib (2007) and pertuzumab (2012).
Kadcyla was reviewed under the FDA’s priority review programme, 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.
The safety and effectiveness of Kadcyla were evaluated in a phase III clinical study (EMILIA) of 991 patients randomly assigned to receive Kadcyla or lapatinib plus capecitabine. Patients received treatment until either the cancer progressed or the side effects became intolerable. The study was designed to measure progression-free survival and overall survival.
Results showed that patients treated with Kadcyla had a median progression-free survival of 9.6 months compared to 6.4 months in patients treated with lapatinib plus capecitabine. The median overall survival was 30.9 months in the Kadcyla group and 25.1 months in the lapatinib plus capecitabine group.
Kadcyla is being approved with a Boxed Warning alerting patients and health care professionals that the drug can cause liver toxicity, heart toxicity and death. The drug can also cause severe life-threatening birth defects, and pregnancy status should be verified prior to starting Kadcyla treatment.
The most common side effects reported in patients treated with Kadcyla were nausea, fatigue, pain in the muscles or joints, thrombocytopenia, increased levels of liver enzymes, headache, and constipation.
Kadcyla is marketed by Genentech, a member of the Roche Group. Genentech expects to launch the drug within two weeks. A course of Kadcyla will cost 9,800 USD. Genentech said its patient assistance programmes will help people who might not be able to afford the drug.
In the breaking news published on same day in the BioWorld, staff writer Randy Osborne wrote that “Kadcyla wowed attendees of the European Society of Medical Oncology in Vienna, Austria, last fall, when promise over the summer – when some data were unveiled at the American Society of Clinical Oncology – came to even more satisfying fruition.”
The EMILIA study was presented as late breaking abstract (LBA12) in the proffered papers session on metastatic breast cancer at the ESMO 2012 Congress in Vienna.
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