Gilead’s Trodelvy slashed the disease risk and helped extend patients’ lives by a median of 3.2 months over the doctors’ choices. The question is, how much will Gilead charge for their drug? If history is any indication, it will be a small fortune.
Trodelvy’s life extension data beat industry expectations. The data met a perceived efficacy bar needed for Trodelvy to clinch at least $1 billion in peak sales, and frankly, that’s all that’s important to Gilead.
When there’s an urgent need, the FDA can grant what’s known as accelerated approval for a drug based on preliminary evidence. In exchange for the accelerated approval, the drugmaker agrees to do definitive follow-up studies to prove that the drug works. But while that work is pending, the company is free to keep selling the drug at a premium price.
NPR analyzed 30 years of FDA and National Institutes of Health data and found that 42% of currently outstanding confirmatory studies, or 50 of them, either took more than a year to begin following accelerated approval or hadn’t started. Nineteen critical studies haven’t started three years or more after accelerated approval. Four of them haven’t started more than ten years later.
Yet, according to the federal accelerated approval regulation, confirmatory studies should “usually be studies already underway” when FDA approves a drug that way.
Let’s also remember that a large amount of cancer data remains hidden.
Data from more than half of cancer trials underpinning drug approvals remains inaccessible, according to a shocking new study that audited over 300 clinical trials backing anti-cancer medicines approved by the US drug regulator over the last ten years.
Of the 304 industry-sponsored clinical trials that provided data for 115 anti-cancer drugs approved by the US Food and Drug Administration (FDA) between 2011 and 2021, only 45 percent had publicly shared patient-level data – or said they would do so when the researchers enquired about accessing data.
The study found that less than one-tenth of trials cited on product labels of three of the top-selling anti-cancer drugs made individual patient data available.
SVB Leerink analyst Geoffrey Porges has previously outlined roughly $1.5 billion in peak sales for Trodelvy in third-line TNBC alone. In comparison, Abrahams has forecast $4.7 billion in peak sales for breast cancer. Analysts have figured that to justify the $21 billion acquisition price for Immunomedics, Trodelvy needs to hit around $4 billion to $5 billion in peak sales, so it’s a sure bet it will be priced in the stratosphere.