Friday, February 5, 2010

FDAs approval of Lapatinib in combination with Letrozole to treat breast cancer...

In my earlier blog, I mentioned about the combination of Lapatinib and Trastuzumab for breast cancer treatment. Now FDA has  approved Lapatinib in combination with Letrozole (see structure ; Letrozole trade name Femara, an oral non-steroidal aromatase inhibitor for the treatment of hormonally-responsive breast cancer after surgery)  to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated. This drug combination of  Lapatinib  & Letrozole provides women being treated for advanced breast cancer with an important treatment option. 

The entirely oral treatment regimen works by targeting both HER2 and the hormone receptors, thereby slowing the cancer cells' ability to grow or spread. As per the claim by  Dr. Richard Pazdur, (Director, Office of Oncology Drug Products, FDA's Center for Drug Evaluation and Research) women with HER2-positive disease receiving the Lapatinib plus Letrozole combination more than doubled the time they lived without the cancer progressing compared with those receiving Letrozole alone (35 weeks vs. 13 weeks).

Lapatinib, was initially approved in combination with a chemotherapy drug, Xeloda (capecitabine) in 2007. This combination was used to treat women with advanced breast cancer tumors with the HER2 protein who had received prior treatment with chemotherapy drugs, including an anthracycline and a taxane, and Herceptin (trastuzumab), an anti-cancer antibody used to treat HER2-positive advanced breast cancer. Safety information from this study was consistent with previous Lapatinib clinical studies in advanced breast cancer. The most commonly reported side effects of the combination were diarrhea, rash, nausea and fatigue. Still clinical trials are to be carried out, in my opinion its a good achievement...

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