Novartis gets EU nod for potential blockbuster breast cancer drug

pharmafile | August 24, 2017 | News story | Sales and Marketing |  CDK4/6, Novartis, biotech, breast cancer, drugs, pharma, pharmaceutical 

Novartis has released that it has received marketing approval from the European Commission for its drug for the treatment of breast cancer, Kisqali. The drug has been approved for use in combination with an aromatase inhibitor for the treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negatie (HR+/HER2-) locally advanced or metastatic breast cancer as a first-line treatment.

The approval builds on the successful application to the FDA earlier in the year and Novartis will hope to build on these approvals to make the medicine a core part of its portfolio. The company has blockbuster expectations from the drug, given the high incidence of HR+/HER2- breast cancer in the global population.

The European Commission’s decision was based on the results of the MONALEESA-2 clinical trial that was able to show that KIsqali plus letrozole reduced the risk of progression or death by 43% over letrozole alone. Additionally, 55% of patients taking the combination treatment experienced tumour reduction of at least 30%.

The approval sets Novartis’ drug for a showdown with Ibrance, Pfizer’s rival CDK4/6 inhibitor that received approval from the EC at the end of 2016. Pfizer’s drug managed to reap over $2 billion in sales in 2016 and Novartis will be hoping that it has joined the market early enough to snag itself a share of the market. Analysts have predicted global annual sales of the drug to reach $1.5 billion by 2022.

“This approval of Kisqali reinforces our recognized leadership in cancer research and our commitment to innovative targeted therapies,” said Bruno Strigini, CEO, Novartis Oncology. “We are proud of our collaboration with study investigators and patients, which provides the medical community with an important new treatment option for women with advanced or metastatic breast cancer.”

Alongside the release, Novartis highlighted that breast cancer is currently the most common cancer in the UK, with 150 new cases diagnosed each day. The infographic also highlighted that three out of 10 women advance to an advanced or metastatic stage from early stage breast cancer.

It released a separate press release alongside the EC approval that was entitled “Novartis Eagerly Awaits NICE Decision Following EU Licensing for Kisqali”. It is an interesting angle to try place pressure on NICE for a quick approval, but it has perhaps been felt necessary after Pfizer suffered a major blow with the surprise rejection of Besponsa recently.

The next drug looking to step into the CDK4/6 arena is Lilly’s Abemaciclib, a drug that already posted strong results from its Monarch 3 trial and has been granted the FDA’s Priority Review. The major drawback for this drug could well be its tendency to cause diarrhoea in those taking the drug – with a reported 90.2% of patients listing this as a side-effect.

This major flaw should see Pfizer’s and Novartis’ drugs take the lead in a market that is expected to grow to $8.8 billion by 2026.

Ben Hargreaves