The newest of Novartis’s听cancer drugs, Kisqali, has received European Union approval. Kisqali will be used as a first-line treatment for a difficult-to-treat breast cancer.听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听expands Novartis’s existing portfolio of cancer drugs, which generated roughly USD 12.79 billion for the company in 2016.听Kisqali will be in direct competition with Pfizer’s Ibrance, which saw sales exceed USD 2 billion last year.
An addition to the growing landscape of breast cancer drugs
Kisqali is a听selective cyclin-dependent kinase inhibitor that will be prescribed听in combination with an aromatase inhibitor. It will be used to treat post-menopausal women who have听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听Phase III MONALEESA-2 trial听that showed that听Kisqali (generically known as听ribociclib), when used with听letrozole, reduced the risk of death or the cancer progressing by 44% when compared to just using letrozole alone.听Novartis has said that it will launch Kisqali immediately in the UK, though it is still waiting on a decision from the听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.
Must Read:听Top 10 Oncology Drugs Companies (2017)
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听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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