STAT+: Pharmalittle: FDA panel lacks confidence in Amgen cancer drug data; weight loss drugs linked to rare stomach problems
A FDA advisory panel voted 10-2 that the data for Amgen's Lumakras lung cancer treatment could not be properly assessed.
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still taking shape, but we expect to hang with our shortest person, who returns for a quick break from an institution of higher learning, catch up on sundry chores and, if possible, hold another listening party. If so, our rotation will likely include this, this, this and this. And what about you? This is a lovely time of year to hop in your driving machine and sojourn through the countryside. You could spend some time tidying up your castle, catch up on your reading, or maybe break open a cookbook and find something that will challenge your taste buds. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
The clearance of a first-of-its-kind cancer treatment made by Amgen is on shakier ground after a U.S. Food and Drug Administration advisory panel voted 10-2 that the data for the Lumakras lung cancer treatment could not be properly assessed, STAT reports. The vote came as Amgen hopes to convert a conditional approval for the drug to a full approval based on a study in which Lumakras met the primary endpoint, delaying tumor growth approximately five weeks longer than the standard of care medication, docetaxel. However, the drug failed to extend overall survival. FDA reviewers rebuked Amgen for the way the follow-up trial was run, stating that there were concerns of “systemic bias.”
Sanofi is exploring a potential acquisition of Mirati Therapeutics, a cancer drug maker, according to Bloomberg News. Mirati is in the process of rolling out its first product to patients, a lung-cancer drug called Krazati. A deal for Mirati would further bolster Sanofi’s drug pipeline, helping the company to reduce its reliance on the blockbuster asthma medicine Dupixent. Sanofi’s backing would help Mirati commercialize Krazati — a second-line treatment for a type of lung cancer in which the the KRAS gene has mutated — and to fund treatment and further studies. Mirati received accelerated approval from U.S. regulators in December, though European regulators have so far withheld support.
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