STAT+: Pharmalittle: FDA finds ‘potential systemic bias’ in Amgen cancer drug trial; drugmakers organize to push back on antitrust reviews
A study of Amgen's Lumakris may reflect systemic biases, the FDA said ahead of a meeting to determine whether the drug should stay on the market.
Hello, everyone, and how are you this fine, sunny morning? The middle of the week has arrived, as you may know, so why not celebrate with a delicious cup of stimulation? After all, you made it this far, which is a likely sign of surviving another few days. And of course, no prescription is required, which is a good thing. Our choice today is butter pecan. And while you drink up, you can peruse some of the tidbits we have assembled to help you start the day. Hope you conquer the world and, as always, do keep in touch. …
A follow-up study of a first-of-its-kind cancer treatment may reflect systemic biases, the U.S. Food and Drug Administration said ahead of an advisory committee meeting Thursday to determine whether the drug should remain on the market, STAT tells us. The treatment, which is called Lumakras and made by Amgen, is designed to treat lung cancer caused by a specific genetic mutation to a protein called KRAS. Lumakras received an accelerated — or conditional — approval in May 2021, making it the first KRAS drug on the market. But in reviewing the study, the FDA found potential data and protocol problems that could jeopardize the entire trial. Now, Amgen needs to prove it works.
The head of Eli Lilly’s burgeoning diabetes and obesity franchise is retiring at the end of the year, The Wall Street Journal notes. Mike Mason, executive vice president and president of Lilly Diabetes & Obesity, is leaving after 34 years with the drugmaker. Over the last four years, he has overseen the development and launch of the blockbuster diabetes drug Mounjaro, which has also gained popularity for off-label use in weight loss as it awaits FDA approval for obesity, and helped propel Eli Lilly’s market capitalization above $500 billion. Patrik Jonsson, currently executive vice president and president of Lilly USA, will take on the additional post.
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