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FDA approval for Kisqali sets up showdown with Ibrance

Novartis breast cancer therapy drug has been predicted to reach blockbuster status

Novartis headquarters Sweden

Novartis has bagged FDA approval for its breast cancer therapy Kisqali, the first direct to competitor to Pfizer's fast-growing breast cancer drug Ibrance.

Like Pfizer's drug, Kisqali (ribociclib; LEE011) is a CDK4/6 inhibitor and has been cleared as an initial treatment - in combination with aromatase inbibitor drugs such as letrozole - for post-menopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

The approval comes just four and a half months after Novartis filed for approval of the drug in the US, and is based on the phase III MONALEESA-2  trial, which was halted early when it showed that giving ribociclib with letrozole reduced the risk of death or the cancer worsening by 44%, compared to those receiving the aromatase inhibitor alone. The FDA had previously awarded the drug both breakthrough status and a priority review.

Analysts at Credit Suisse have predicted Novartis' drug will be a $1.2bn product by 2020, giving the product some work to do to catch Ibrance (palbociclib), which saw sales of more than double last year to reach $2.1bn.

EvaluatePharma thinks Ibrance will become a mega-blockbuster with sales of $6bn-plus in 2022, consigning its rivals into a fight for second place. With the approval Novartis has however pulled ahead of Eli Lilly, whose CDK4/6 inhibitor abemaciclib is in phase III but – unlike ribociclib – did not get the benefit of an early trial termination.

Novartis' chief medical officer Vasant Narasimhan has previously said that the company expects ribociclib to "capture a significant portion in a three-player market".

There have however been reports of cardiac anomalies (QT prolongation) and hepatotoxicity in a small proportion of patients treated with ribociclib, but Novartis has indicated these have been manageable with monitoring and dose reductions or interruptions and did not result in any patient deaths in studies to date. The product's prescribing information recommends liver function testing and ECG monitoring before starting treatment with the drug.

Pfizer insists it hasn't seen any evidence of those effects, and it remains to be seen whether tolerability will play a role in Kisqali's roll-out. Novartis has experience of marketing drugs with QT prolongation, a side effect which affects its chronic myeloid leukemia (CML) therapy Tasigna (nilotinib) but has not stopped the drug from becoming a blockbuster with sales of $1.7bn last year.

Novartis is looking to quickly ramp up Kisqali's approved indications to take the fight to Ibrance. It is conducting the MONALEESA-3 study in first-line and second-line in combination with fulvestrant, another widely-used aromatase inhibitor. That could be critical in light of recent data showing that fulvestrant is more effective than letrozole in the first-line setting.

Meanwhile, another trial called MONALEESA-7 is looking at the drug in pre-menopausal women with breast cancer, and Novartis has other studies assessing ribociclib as an adjuvant therapy alongside surgery in patients with earlier-stage disease.

Article by
Phil Taylor

14th March 2017

From: Regulatory



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