Home Market News <!DOCTYPE html> <html> <head> <title>Amgen’s Lumakras: FDA Requests Additional Data for Full Approval</title> </head> <body> Amgen’s Lumakras: FDA Requests Additional Data for Full Approval

Amgen’s Lumakras: FDA Requests Additional Data for Full Approval Amgen’s Lumakras: FDA Requests Additional Data for Full Approval

0
<!DOCTYPE html>
<html>
<head>
	<title>Amgen’s Lumakras: FDA Requests Additional Data for Full Approval</title>
</head>
<body>
	Amgen’s Lumakras: FDA Requests Additional Data for Full Approval
Amgen office building in Mississauga, Ontario, Canada.

JHVEPhoto/iStock Editorial via Getty Images

Amgen (NASDAQ:AMGN) has hit a roadblock with its lung cancer therapy, as the U.S. Food and Drug Administration (FDA) has declined the company’s request for full approval of its drug, Lumakras (sotorasib). The setback comes as the FDA is demanding additional data before granting full approval for the treatment.

The FDA’s issuance of a Complete Response Letter to Amgen’s (AMGN) supplemental New Drug Application (sNDA) means that the regulatory body has set a new post-marketing condition, compelling the company to conduct an additional confirmatory study to support the drug’s efficacy.

In a surprising turn of events, the FDA’s decision has prompted a setback for Amgen, particularly as Lumakras became the first U.S.-approved KRASG12C inhibitor in May 2021, following the FDA’s clearance under the agency’s accelerated approval pathway. The drug was positioned as a late-line option for non-small cell lung cancer (NSCLC).

The FDA’s requirement for an additional confirmatory study comes with a deadline. Amgen (AMGN) is expected to complete the trial aimed at securing full approval for Lumakras by February 2028. This unexpected hurdle poses a challenge for the company, especially in the face of rivalry from other developers of KRASG12C inhibitors, with Mirati Therapeutics (MRTX) being a significant contender.

It’s worth noting that Mirati Therapeutics’ (MRTX) KRASG12C inhibitor, Krazati, received FDA-accelerated approval for NSCLC in December 2022, adding to the competitive landscape in this space.