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The newest of Novartis’s cancer drugs, Kisqali, has received European Union approval. Kisqali will be used as a first-line treatment for a difficult-to-treat breast cancer. The company expects Kisqali to be a blockbuster in the oncology pharmaceutical market, projecting that it will generate sales revenue in the billions.
This approval expands Novartis’s existing portfolio of cancer drugs, which generated roughly USD 12.79 billion for the company in 2016. Kisqali will be in direct competition with Pfizer’s Ibrance, which saw sales exceed USD 2 billion last year.
Kisqali is a selective cyclin-dependent kinase inhibitor that will be prescribed in combination with an aromatase inhibitor. It will be used to treat post-menopausal women who have hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer.
The EU approval was granted based on evidence from the Phase III MONALEESA-2 trial that showed that Kisqali (generically known as ribociclib), when used with letrozole, reduced the risk of death or the cancer progressing by 44% when compared to just using letrozole alone. Novartis has said that it will launch Kisqali immediately in the UK, though it is still waiting on a decision from the National Institute for Health and Care Excellence (NICE) regarding NHS coverage for this new cancer drug. EU pricing for Kisqali has yet to be released.
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In the United States, Novartis released Kisqali with a flexible pricing scheme to help fight off competition from other cancer drugs that treat the same type of breast cancer, such as Ibrance. It is also expected to help offset Kisqali’s potential disadvantages, especially the requirement that, as per US labelling and regulations, patients receiving treatment with Kisqali will need ECG monitoring before beginning treatment and two weeks after.
Kisqali may face some additional competition in the very near future: Eli Lilly is currently in the late stages of clinical development of its abemaciclib candidate for breast cancer treatment. It’s a great sign that the types of breast cancer drugs available on the market are expanding and giving patients greater choice and availability for treatment options.
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