Novartis pill reduces breast cancer recurrence by 25%

New data on Kisqali, a breast cancer pill sold by Novartis, could lead to a financial windfall for the pharma giant. The drug reduced the recurrence of the most common type of breast cancer by 25% in a large trial, which could broaden the use of the drug and push the market for it to $3 billion, the company says. The results will be presented later today at ASCO.

There's some debate over how much stronger Kisqali might be compared to other drugs in its class, because these findings — while dramatic overall — were not statistically significant in patients whose cancer had not spread to the lymph nodes. So it's possible the FDA might want more data before giving the broadest approval to Kisqali.

alzheimer's

Despite protest, Medicare sticking to Alzheimer's coverage plan

Medicare has no plans to change its approach to covering new Alzheimer's drugs like Leqembi, which could gain full approval within a month. The federal payer said it will continue requiring patient registries to collect data on how the drugs perform even after they get an FDA approval — a move that advocates call an "unnecessary barrier."

Members of Congress are pushing for Medicare to at least clarify how providers can work within the data collection infrastructure so they might immediately start giving the medicine to patients if it achieves a full FDA approval.

"Establishing a precedent where the agency can restrict coverage for new medicines, singling out groups of patients and exacerbating health disparities, is not in the best interest of patients," said a spokesperson for Eli Lilly, which is developing its own Alzheimer's treatment.

podcast

Why are fake medical devices more lucrative than real ones?

Is Ozempic a neurological treatment? And what's at the cutting edge of oncology? We cover all that and more this week on "The Readout LOUD," STAT's biotech podcast. Our colleague Lizzy Lawrence joins us to explain the shocking story of a medical device company that sold fake implants and the warped system that made the scam lucrative. We'll also preview the year's biggest cancer research meeting and discuss a surprising twist with novel weight loss medicines.

Listen here.

Biosimilars

Coherus, Mark Cuban to sell Humira biosimilar at steep discount

Biosimilar maker Coherus BioSciences plans to sell an alternate version of the best-selling Humira at a fraction of the cost. And it will work with Mark Cuban's generic drug company to sell the biosimilar directly to consumers for even less. The Coherus biosimilar will have a list price of $995 for a carton of two auto injectors, which is an 85% discount from the $6,922 that AbbVie charges for Humira. And it'll sell its drug at a discount to the Mark Cuban Cost Plus Drug Company, which then will sell it directly to consumers for $579.

Humira, which is used for autoimmune conditions like rheumatoid arthritis and ulcerative colitis, held a monopoly on a lucrative market for years — bringing in billions in sales each year for its maker, AbbVie. Now, there will be at least eight biosimilar rivals to Humira by the end of the year.