Nuvalent Gets FDA Breakthrough Therapy Designation for Lung-Cancer Treatment
By Paul Ziobro
Nuvalent said federal regulators have granted breakthrough therapy designation for NVL-655 to treat patients with a certain type of lung cancer.
The clinical-stage biopharmaceutical company on Thursday said that the Food and Drug Administration granted the status for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer who have been previously treated with two or more ALK tyrosine kinase inhibitors, or TKIs.
The company said there remains no clear standard of care for patients who have been previously been treated with two or more ALK TKIs.
The breakthrough therapy designation is designed by the FDA to expedite the development and evaluation of treatments for serious or life-threatening conditions if they have preliminary clinical evidence showing substantial improvement at certain endpoints over currently available therapies.
Write to Paul Ziobro at paul.ziobro@wsj.com
(END) Dow Jones Newswires
May 16, 2024 16:31 ET (20:31 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
What Does Nvidia’s Stock Split Mean for Investors?
-
5 Undervalued Stocks to Buy as Their Stories Play Out
-
Markets Brief: Return of the Meme Stocks
-
What’s Happening In the Markets This Week
-
It’s Been a Terrible Time for Bonds. Here’s Why You Should Own Them
-
Which AI Stocks Are Turning Hype Into Revenue?
-
Best- and Worst-Performing Stocks of May 2024
-
3 Stocks to Buy and 3 Stocks to Sell in June
-
5 Ultracheap Stocks to Buy With the Best Returns on Investment
-
Broadcom Earnings: AI Sales Growth Accelerates
-
Oracle Earnings: IaaS Signings More Than Make Up for Miss
-
This Undervalued Stock Is a Buy After Its Dividend Increase
-
After Earnings, Is Nio Stock a Buy, a Sell, or Fairly Valued?
-
After Earnings, Is Lululemon Stock a Buy, a Sell, or Fairly Valued?
-
The 10 Best Dividend Stocks
-
The Most Attractive Investment Opportunities in Oil & Gas