Taletrectinib Approved for Locally Advanced and Metastatic NSCLC with ROS1 Rearrangements

On June 11, 2025, the US Food and Drug Administration (FDA) announced the approval of taletrectinib (Ibtrozi™) to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with ROS1 rearrangements.  

Taletrectinib is a next-generation, highly specific kinase inhibitor of ROS1 that was designed to treat ROS1+ NSCLC in patients whose tumors have developed drug resistance to previous targeted therapies as well as a first treatment option for newly diagnosed patients.  

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Surviving LMD: Michelle Never Settled for “No”

Michelle knew what was wrong. She knew the headaches, regular vomiting, ear popping, and “whooshing” sounds in her head were all signs of leptomeningeal disease (LMD). The issue, however, is that LMD is so rare—only diagnosed in 5% of people with cancer—she had to advocate for the testing to prove it.

“I called my clinic and said I needed a brain MRI because I think I have LMD. They didn’t want to schedule one, so I said, tell my doctor I’m demanding a brain MRI. I can tell him directly if I need to,” says Michelle.

New Treatment Approved for NSCLC with High Level of c-Met Protein

On May 14, 2025, the US Food and Drug Administration (FDA) announced the approval of telisotuzumab vedotin-tllv (EMRELIS™) to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with high levels of c-Met protein who have been previously treated with a systemic therapy, such as immunotherapy or chemotherapy.  

This ADC, or antibody-drug conjugate, is the first approval of its kind. This ADC treatment is designed with two key elements.  

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The Promise of PROTACs for Treating RET+ Lung Cancer

RET proteins are a type of receptor tyrosine kinase—an important group of signaling molecules in healthy cells. When RET proteins are turned “on” and “off” in healthy cells, they control the function of other proteins. This cascading effect allows the cells to manage important cellular functions such as cell growth through protein signaling pathways.  

What Should Patients Know About Lung Cancer Surgery?

Surgery is a treatment option for early-stage lung cancer that involves removing all or part of a lung to treat a cancerous tumor. It is primarily an option for people with non-small cell lung cancer (NSCLC) staged at I, II, or IIIA. Surgery is rarely considered for tumors at stage IIIB or IV because those lung cancers have spread to other parts of the body.

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RET-Positive Lung Cancer: New Treatments and Beyond

The four-person panel, including John Heymach, MD, PhD, from MD Anderson Cancer Center, discuss the current FDA-approved targeted treatments for RET-positive lung cancer—selpercatinib (Retevmo) and pralsetinib (Gavreto). While these first-line treatments have proven helpful in treating RET-positive non-small cell lung cancer, the cancer cells can eventually become resistant to the treatment, which is guiding much of Dr. Heymach’s attention at the moment.

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