Merck Gets FDA Breakthrough Designation for Calderasib in NSCLC
By Colin Kellaher
Merck & Co. has won U.S. Food and Drug Administration breakthrough-therapy designation for its investigational KRAS G12C inhibitor calderasib in certain patients with non-small cell lung cancer, or NSCLC.
Merck on Friday said the designation covers calderasib in combination with its blockbuster cancer drug Keytruda for the first-line treatment of patients with advanced or metastatic KRAS G12C-mutant NSCLC.
Mutations in the KRAS gene are among the most prevalent mutations found in cancer, and the KRAS G12C mutation is the most frequently observed KRAS mutation in patients, occurring in roughly 14% of patients with NSCLC, the Rahway, N.J., drugmaker said.
The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug might offer substantial improvement over available therapies.
Merck is developing calderasib through a collaboration with two units of Japan's Otsuka Holdings.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 29, 2026 07:41 ET (11:41 GMT)
Copyright (c) 2026 Dow Jones & Company, Inc.The articles, information, and content displayed on this webpage may include materials prepared and provided by third parties. Such third-party content is offered for informational purposes only and is not endorsed, reviewed, or verified by Morningstar.
Morningstar makes no representations or warranties regarding the accuracy, completeness, timeliness, or reliability of any third-party content displayed on this site. The views and opinions expressed in third-party content are those of the respective authors and do not necessarily reflect the views of Morningstar, its affiliates, or employees.
Morningstar is not responsible for any errors, omissions, or delays in this content, nor for any actions taken in reliance thereon. Users are advised to exercise their own judgment and seek independent financial advice before making any decisions based on such content. The third-party providers of this content are not affiliated with Morningstar, and their inclusion on this site does not imply any form of partnership, agency, or endorsement.
Popular
4 Stocks to Buy Before They Rise Further
2 Undervalued Stocks to Buy Before They Rebound
The 10 Best Dividend Stocks
12 Best Blue-Chip Stocks to Buy for the Long Term
United States