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FDA Approves Hyrnuo (sevabertinib) for HER2-Mutated NSCLC

2025-11-20T11:03:14-06:00November 20th, 2025|Hot Topics, News, Science and Research|

Did you know? HER2 is a gene found in cells that is important for cell growth and survival. You may also sometimes see HER2 referred to by the name ERBB-2. In some people, the HER2 gene begins to change or mutate, which can be a driving cause of lung cancer. There are different types of mutations in HER2 for lung cancer, but the most common change occurs when new information is inserted into a specific part of the HER2 gene [...]

FDA Approves a New Combination Treatment for Extensive-Stage Small Cell Lung Cancer 

2025-10-03T09:50:38-05:00October 3rd, 2025|Hot Topics, News, Science and Research, Small Cell Lung Cancer|

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 has not progressed after initial first-line treatment with Tecentriq (atezolizumab), Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), carboplatin, and etoposide. Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) is the subcutaneous form of Tecentriq (atezolizumab) and is given by a shot (injection) under the skin.  This [...]

FDA Approves New Administration Method for Keytruda (pembrolizumab)

2025-09-22T11:46:06-05:00September 22nd, 2025|Hot Topics, News, Science and Research|

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, in addition to the usual administration method of infusion into the bloodstream (intravenous/IV).   Keytruda (pembrolizumab) is already approved for use in several cancers, including non-small cell lung cancer (NSCLC). Until now, it was administered through an IV into the bloodstream, which [...]

FDA Approves Hernexeos (zongertinib) for HER2-Mutated NSCLC 

2025-08-11T11:05:12-05:00August 11th, 2025|Hot Topics, News, Science and Research|

Did you know? HER2 is a gene found in cells that is important for cell growth and survival. You may also sometimes see HER2 referred to by the name ERBB-2. In some people, the HER2 gene begins to mutate or change, which can be a driving cause of cancer. There are many different types of changes in HER2 for lung cancer, but the most common change occurs when new information is inserted in a specific part of the HER2 gene [...]

FDA Approves Zegfrovy (sunvozertinib) for EGFR-Mutated NSCLC with an Exon 20 Insertion

2025-07-07T14:10:57-05:00July 7th, 2025|Hot Topics, News, Science and Research|

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, which can be a driving cause of cancer. There are many different types of changes in EGFR for lung cancer, such as when new genetic information is inserted into a part of the EGFR gene called exon 20. When this occurs, it’s called an EGFR exon 20 insertion. EGFR exon 20 [...]

FDA Approves Datroway (datopotamab deruxtecan-dlnk) for EGFR-positive NSCLC 

2025-06-24T11:53:59-05:00June 24th, 2025|Hot Topics, News, Science and Research|

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 happens, it can be a driving cause of cancer. When changes in the EGFR gene cause lung cancer, it’s called EGFR-positive lung cancer. EGFR-positive lung cancer occurs in about 15 out of every 100 cases (15%) of lung cancer.   On [...]

FDA Approves Ibtrozi (taletrectinib) for ROS1-positive NSCLC 

2025-06-12T08:58:11-05:00June 12th, 2025|Hot Topics, News, Science and Research|

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 happens, it can be a driving cause of cancer. When changes in the ROS1 gene cause lung cancer, it’s called ROS1-positive lung cancer. ROS1-positive lung cancer occurs in about 2 out of every 100 cases (2%) of lung cancer.  On [...]

FDA Approves Emrelis (telisotuzumab vedotin-tllv) for High c-MET Expressing NSCLC

2025-05-16T08:32:29-05:00May 15th, 2025|Hot Topics, News, Science and Research|

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 much of a protein called c-MET.  On May 14, 2025, the U.S. Food and Drug Administration (FDA) announced accelerated approval of Emrelis (telisotuzumab vedotin-tllv) for people with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) who have high [...]

FDA Approves New Administration Method for Opdivo (nivolumab)

2025-01-06T10:20:40-06:00January 6th, 2025|Hot Topics, News, Science and Research|

On December 27, 2024, the U.S. Food and Drug Administration (FDA) approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) for subcutaneous injection, commonly known as a shot. This approval included all the same uses of Opdivo (nivolumab) that the FDA previously approved for adults, including for use as a standalone therapy or in combination with other treatments for non-small cell lung cancer (NSCLC).  This latest approval is based on the results of the CHECKMATE-67T study, which compared the use of Opdivo Qvantig (nivolumab [...]

FDA Approves Ensacove (ensartinib) for Locally Advanced or Metastatic ALK-Positive NSCLC

2024-12-19T10:06:22-06:00December 19th, 2024|Hot Topics, News, Science and Research|

On Dec. 18, 2024, the U.S. Food and Drug Administration (FDA) approved Ensacove (ensartinib) for people with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have an ALK mutation and have not previously received an ALK-targeted therapy.  Ensacove (ensartinib) represents a new first-line treatment option for those with ALK-positive NSCLC, found in about 4% of lung cancer diagnoses.  This approval is based on the results of the eXALT3 study, which looked at treating people with locally advanced or [...]

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