Novartis Kisqali® (Ribociclib) Receives EU and FDA Approval


Novartis Kisqali (ribociclib) receives EU and FDA approval as first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitor. Ribociclib is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.

Kisqali are film-coated tablets supplied for oral use containing 200 mg of ribociclib free base. The tablets also contains as colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, magnesium stearate and microcrystalline cellulose. The film-coating contains iron oxide black, iron oxide red, polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide, xanthan gum and soybean lecithin as suspension stabiliser. The surface active and viscosity increasing properties of soybean lecithin make it favourable for the formulation stability as well as in the coating process. Soybean lecithin as film coating excipient in Kisqali underlines the usability in classical pharmaceutical formulations and the broad field of application.

Novartis, Press Release, March 13th/Apr. 24th, 2017