Novartis picked up a key regulatory win today, gaining the FDA’s quick OK for LEE011, its CDK 4/6 drug now approved as a frontline therapy for postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in combination with any aromatase inhibitor.
The drug, also known as ribociclib, hits the market as Kisqali with peak sales estimates of around $2.5 billion a year, giving the pharma giant a clear shot at a new blockbuster franchise.
The pharma giant has kept to the inside track at the FDA right through the review. The OK now puts Novartis in direct competition with Pfizer’s Ibrance (palbociclib), the pioneer in this field, with Eli Lilly coming up from behind with abemaciclib.
The headline figure from ESMO, based on a study that was wrapped early due to its success, was that ribociclib combined with letrozole reduced the risk of death or progression by 44% among first-line patients compared to letrozole alone.
Researchers also pegged median PFS of 25.3 months for Kisqali plus letrozole compared to 16 months for letrozole alone.
Bill Hinshaw, head of Novartis US Oncology, told reporters this afternoon that they’ve priced this drug wholesale at $10,950 for the 600 mg dose, $8,760 for their 400 mg dose and $4,380 at 200 mg for a 28-day package with 21 pills, to allow for flexible dosing and pricing. Patients can also get the drug at no upfront cost as they’re working out details with their insurer.
Seamus Fernandez at Leerink is going with Pfizer in this showdown, noting that Novartis’ price is an 18% to 20% discount over Ibrance, which should help it bore its way onto payers’ formularies. Be he also asserts that safety issues with Kisqali will limit its market penetration, favoring Ibrance.
The closely-watched data have kept this drug squarely in the sights of analysts covering this market. It’s a top-10 contender this year, in the front ranks of late-stage blockbusters, with an EMA decision expected in the second half of this year. There was no immediate word on how much Novartis plans to charge for the drug.
“Kisqali is emblematic of the innovation that Novartis continues to bring forward for people with HR+/HER2- metastatic breast cancer,” said Bruno Strigini, CEO, Novartis Oncology. “We at Novartis are proud of the comprehensive clinical program for Kisqali that has led to today’s approval and the new hope this medicine represents for patients and their families.”
The UK’s Astex is also chuffed. Astex and Novartis began collaborating on discovery back in 2005, starting them down a path that led to this new drug.
Gabriel N. Hortobagyi, MD, Professor of Medicine, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center and MONALEESA-2 Principal Investigator, noted:
These results affirm that combination therapy with a CDK4/6 inhibitor like ribociclib and an aromatase inhibitor should be a new standard of care for initial treatment of HR+ advanced breast cancer.
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