On October 2, 2025, the U.S. Food and Drug Administration (FDA) approved Zepzelca (lurbinectedin) in combination with Tecentriq (atezolizumab) or Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) as maintenance therapy for adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease [...]
On September 19, 2025, the U.S. Food and Drug Administration (FDA) approved a new administration method for Keytruda (pembrolizumab). Under the new approval, Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) can now be given by subcutaneous injection, commonly known as a shot, [...]
Did you know? EGFR is a gene found in cells that is important for cell growth and survival. In some people, the EGFR gene begins to mutate or change and may fuse or join with another gene. When this [...]
Did you know? ROS1 is a gene found in cells that is important for cell growth and survival. In some people, the ROS1 gene begins to mutate or change and may fuse or join with another gene. When this [...]
Did you know? There are different kinds of changes, called mutations, that can happen in the MET gene. These changes can help cancer grow and spread. One type is called c-MET overexpression. This means the cancer cells make too [...]
Author: Matthew Reiss, MSE, PhD, Manager, Precision Medicine & Navigation, GO2 for Lung Cancer Question: Why does it take so long for the FDA to approve new drugs? Answer: Whenever a new cancer drug is created, it [...]
On October 15, 2024, the U.S. Food and Drug Administration (FDA) approved the use of a wearable treatment device, Optune Lua, in combination with PD-1/PD-L1 immunotherapies or the chemotherapy docetaxel for people with metastatic non-small cell lung cancer (NSCLC) [...]
On October 3, 2024, the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) to be used with platinum-doublet chemotherapy as a treatment before surgery, followed by Opdivo (nivolumab) alone after surgery. This approval is for people with resectable (removable [...]
Author: Matthew Reiss, MSE, PhD, Manager, Precision Medicine & Navigation, GO2 for Lung Cancer The first anti-cancer therapy, mechlorethamine, was approved in 1949. Since then, the U.S. Food and Drug Administration (FDA) has worked to ensure that new lifesaving [...]
On Nov. 16, 2023, the U.S. Food and Drug Administration (FDA) approved Augtyro (repotrectinib) for people living with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a ROS1 gene mutation. The approval was based on results from [...]