T-DM1 Approved For Her2 Breast Cancer
Kadcyla is a conjugate – it combines the drug trastuzumab, better known by the brand name Herceptin, and a powerful chemotherapy drug called DM1. The trastuzumab portion targets HER2+ cells, then the attached chemotherapeutic molecule – the DM1, which is too toxic to deliver directly into the patient’s bloodstream – is delivered and attacks the cancer cell. T-DM1 has helped inspire a new generation of antibody + drug conjugates.
FDA approval was based on a study known as EMILIA, in which patients with HER2+, metastatic breast cancer who had failed treatment with a combination of trastuzumab and taxane were randomized to ado-trastuzumab emtansine or conventional therapy with lapatinib and capecitabine (Xeloda). The patients given ado-trastuzumab emtansine resulted in significant improvements in both progression-free survival (9.6 vs 6.4 months) and overall survival (30.9 vs 25.1 months).
The Down-Side (Why Is There Always A Down-Side?)
This sounds like really great news, however, the drug is not without risk (what else is new?). The FDA requires labeling on Kadcyla to warn of risks of liver toxicity, reductions in left ventricular ejection fraction for the heart, and death. In addition, there is risk of severe birth defects, so a woman’s pregnancy status should be determined before starting treatment, the FDA said. The most common side effects associated with the drug were nausea, fatigue, musculoskeletal pain, thrombocytopenia, elevated liver enzymes, headache, and constipation.
As if all of that weren’t enough, the drug will cost $9,800 a month, or about $94,000 for a 9.5-month course of therapy. Let’s hope it can keep people alive.
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