On August 19, 2024, the U.S. Food and Drug Administration (FDA) approved lazertinib (Lazcluze^™) in combination with amivantamab-vmjw (Rybrevant^®) for first-line treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution variants, as detected by an FDA-approved test.

On August 15, 2024, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi^®) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery, for adults with resectable (tumors that are 4 cm or larger or node positive) non-small cell lung cancer and no known epidermal growth factor receptor variants or anaplastic lymphoma kinase rearrangements.

Over the past two decades, the treatment of metastatic non-small cell lung cancer has dramatically evolved with the introduction of targeted therapies and immunotherapy. These advancements require predictive molecular tests to determine which treatments are suitable for patients. Biomarker testing has become vital in lung cancer care, enabling personalized diagnosis and treatment by identifying specific genetic variants. 

Basing lung cancer screening eligibility decisions on pack-year history misses about 27% of Black patients and 8% of White patients who should otherwise qualify for screening, researchers reported in study findings published in the Journal of Clinical Oncology. They found that total smoking duration history was a more accurate indicator of individuals who should be offered lung cancer screening.

On May 16, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tarlatamab-dlle (Imdelltra™) for extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.

On April 18, 2024, the U.S. Food and Drug Administration (FDA) approved alectinib (Alecensa^®) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)–positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

On March 1, 2024, the U.S. Food and Drug Administration (FDA) approved amivantamab-vmjw (Rybrevant^®) with carboplatin and pemetrexed for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion variants, as detected by an FDA-approved test.

On February 16, 2024, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso^®) with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R variants, as detected by an FDA-approved test.

On February 15, 2024, the U.S. Food and Drug Administration (FDA) granted traditional approval to tepotinib (Tepmetko^®) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations.

People aged 50–80 years who are current smokers or have quit and have a smoking history of 20 or more pack-years should be screened annually with low-dose computed tomography, according to the American Cancer Society’s 2023 updated lung cancer screening guidelines.

On November 15, 2023, the U.S. Food and Drug Administration (FDA) approved repotrectinib (Augtyro™) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This is the first FDA approval for treatment of patients with ROS1-positive NSCLC who have previously received a ROS1 tyrosine kinase inhibitor (TKI), in addition to patients who are TKI naïve.

“The FDA is prepared to use all of its authorities to ensure these, and other illegal and youth-appealing products, stay out of the hands of kids. We are committed to a multipronged approach using regulation, compliance, and enforcement action and education to protect our nation’s youth.” 

—Robert M. Califf, MD, U.S. Food and Drug Administration (FDA) Commissioner 

On October 16, 2023, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) with platinum-containing chemotherapy as neoadjuvant treatment and with continuation of single-agent pembrolizumab as postsurgical adjuvant treatment for resectable (tumors ≥ 4 cm or node positive) non-small cell lung cancer (NSCLC).

On October 11, 2023, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi^®) with binimetinib (Mektovi^®) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E variant, as detected by an FDA-approved test.

In August 2022, the U.S. Food and Drug Administration granted regular approval to capmatinib (Tabrecta®) for adults with metastatic non-small cell lung cancer whose tumors have a variant that leads to mesenchymal-epithelial transition exon 14 skipping. Capmatinib was granted accelerated approval for the same indication in May 2020; the regular approval in August 2022 was based on additional data from 63 patients and follow-up data establishing durability of response and clinical benefit.

On August 9, 2023, the U.S. Food and Drug Administration (FDA) granted regular approval to pralsetinib (Gavreto^®) for adult patients with metastatic, rearranged during transfection fusion-positive non-small cell lung cancer as detected by an FDA-approved test.

Increases in early-stage lung cancer diagnoses with low-dose computed tomography screening have led to sustained improvements in survival rates more than 20 years later, researchers said while presenting their study findings at the 2022 Radiological Society of North America annual meeting.

On January 26, 2023, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda®) for adjuvant treatment following resection and platinum-based chemotherapy of patients with stage IB (T2a ≥ 4 cm), II, or IIIA non-small cell lung cancer.

On December 12, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to adagrasib (Krazati^®), a RAS GTPase family inhibitor, for adult patients with KRAS G12C–variant locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, and who have received at least one prior systemic therapy.

On November 10, 2022, the U.S. Food and Drug Administration approved tremelimumab (Imjudo®) in combination with durvalumab (Imfinzi®) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer with no sensitizing epidermal growth factor receptor (EGFR) variant or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

More than 95% of germline genetic variants identified through genetic testing in patients with lung cancer are potentially clinically actionable, researchers reported in study findings during the 2022 ASCO Plenary Series Program, leading them to recommend testing all patients with the disease.

On September 21, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to selpercatinib (Retevmo®) for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion and accelerated approval for adults with locally advanced or metastatic solid tumors with a RET gene fusion that progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

On August 11, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu®) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 (HER2) variants, as detected by an FDA-approved test, and who have received a prior systemic therapy. This is the first drug approved for HER2-variant NSCLC.

On August 10, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to capmatinib (Tabrecta®) for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation leading to mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA-approved test.

People with a history of e-cigarette use have a higher risk of developing both lung and bladder cancer than never smokers or even users of regular cigarettes, according to study findings researchers reported during the 2022 American Society of Clinical Oncology Genitourinary Cancers Symposium.

More Medicare beneficiaries now meet age, smoking history, and other criteria for lung cancer screening and are now eligible to receive low-dose computed tomography (LDCT), according to a February 2022 memo from the Centers for Medicare and Medicaid Services (CMS).

On March 4, 2022, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo^®) with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting, representing the first FDA approval for neoadjuvant therapy for early-stage NSCLC.

Biomarker testing is an essential tool when choosing the right treatment for many advanced solid cancers. However, tissue-based testing may take weeks to get results with a chance that not enough tissue was collected to complete the entire biomarker panel. Blood draw–based liquid biopsies may be a useful alternative to identify a tumor’s biomarker details and can be performed by testing for circulating tumor DNA (ctDNA).

Most lung cancers in patients who have no smoking history are the result of natural genetic variants in the body that can be classified into one of three molecular subtypes, researchers reported in study finding published in Nature Genetics.

After clinical trials demonstrated a 40% overall response rate with 63% of responses lasting six months or more, on May 21, 2021, the U.S. Food and Drug Administration (FDA) approved amivantamab-vmjw (Rybrevant^TM) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion variants, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

Sotorasib offers a durable clinical benefit without new safety signals in patients with previously treated KRAS p.G12C-variant non-small cell lung cancer, according to the results of a clinical trial that led to the therapy’s U.S. Food and Drug Administration (FDA) approval. The researchers reported the findings in the New England Journal of Medicine.

After clinical trials demonstrated an overall response rate of 36% and median response duration of 10 months, the U.S. Food and Drug Administration granted sotorasib (Lumakras^TM) accelerated approval on May 28, 2021, for the treatment of adults with KRAS G12C–altered locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

On October 15, 2021, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq^®) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II–IIIA non-small cell lung cancer (NSCLC) with PD-L1 expression on ≥ 1% of tumor cells as determined by an FDA-approved test. 

Young people who see anti-vaping advertisements and prevention campaigns are more likely to have accurate e-cigarette knowledge, which can lead to a decrease in tobacco use and consequently, lung cancer diagnoses, according to a July 2021 study from the Truth Initiative, an organization devoted to educating youth about smoking and tobacco industries.

American youth reported a decline in using any tobacco product in 2020 compared to 2019 but no significant decrease in the use of cigarettes, hookah, pipe tobacco, or heated tobacco products, according to 2020 U.S. Food and Drug Administration (FDA) survey findings on youth tobacco use. Despite the decline, FDA said that the data shows “disturbingly high rates of frequent and daily e-cigarette use” and strong nicotine dependence among youth.

Cancer mortality for all racial and ethnic groups in the United States continues to decline, with death rates for lung cancer and melanoma decreasing faster than others, according to findings that the American Cancer Society (ACS), the Centers for Disease Control and Prevention, the National Cancer Institute, and the North American Association of Central Cancer Registries (NAACCR) published in their July 2021 Annual Report to the Nation on the status of cancer.

On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sotorasib (Lumakras™), a RAS GTPase family inhibitor, for adult patients with KRAS G12Cmutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy.

On May 21, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to amivantamab-vmjw (Rybrevant™), a bispecific antibody directed against epidermal growth factor receptor (EGFR) and MET receptor, for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. FDA also approved the Guardant360^® CDx as a companion diagnostic.

Testing for molecular biomarkers has become a mainstay in determining treatment approaches for advanced-stage non-small cell lung cancer. Typically, next-generation sequencing identifies any potential genomic variants that are associated with oncogenic driver events and can be targeted with oral tyrosine kinase inhibitors.

Patients with higher muscle quality during treatment with PD-1/PD-L1 inhibitor monotherapy for non-small cell lung cancer (NSCLC) had higher overall response rates and longer progression-free survival than patients with lower-quality skeletal muscle, researchers reported in study findings published in Cancer Medicine.

The draft 2020 U.S. Preventive Services Task Force (USPSTF) lung cancer screening recommendations were intended to increase the number of high-risk minorities eligible for lifesaving tests. And they do, but not as much as USPSTF anticipated, still leaving gaps and disparities, researchers reported in the Journal of the National Cancer Institute. They created a risk model to augment the guidelines that eliminated the disparities for most racial groups.

On March 3, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to lorlatinib (Lorbrena®) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. FDA also approved the Ventana ALK (D5F3) CDx Assay as a companion diagnostic for lorlatinib.

On February 22, 2021, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo^®) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation and whose tumors have high PD-L1 expression (tumor proportion score ≥ 50%) as determined by an FDA-approved test, with no estimated aberrations to glomerular filtration rate, anaplastic lymphoma kinase, or receptor tyrosine kinase (encoded by the ROS1 gene). 

On February 3, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib (Tepmetko^®) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition exon 14 skipping alterations.

Although overall smoking rates are decreasing among adolescents and young adults, a new trend is emerging: those who smoked their first cigarette between ages 18–23 increased from 21% in 2002 to 43% in 2018, researchers reported in JAMA Network Open. The increase in young adult first-time smokers comes at a time when smoking initiation rates are decreasing among younger teenagers.

The U.S. Senate unanimously passed a resolution designating November as National Lung Cancer Awareness Month and supporting early detection of lung cancer, a crucial awareness with smoking on the rise among young adults.

On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso^®) as adjuvant therapy after tumor resection for patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test. 

Lung cancer knows no state boundary or political ideology. But it can bring the two sides together, like it did when U.S. Senators Tina Smith (D-MN), member of the Senate Health Committee, and Marco Rubio (R-FL) introduced a resolution to recognize November as National Lung Cancer Awareness Month. The resolution, which ONS supports, promotes the importance of and need to improve lung cancer early detection.

The average age at which cigarette users start to smoke regularly has risen. Although the figures dropped from 45% of adults smoking cigarettes in the 1960s to 14% today, and teen smoking declined to 2.4% by 2019, results of a recent study show an upward trend of underage tobacco use in young adults.  

In May 2020, the U.S. Food and Drug Administration gave accelerated approval for selpercatinib (Retevmo^®) to treat RET-altered non-small cell lung cancer or thyroid cancer based on overall response rate and duration of response. Selpercatinib fights cancer by impeding RET protein activity. The determining clinical trial results demonstrated that it reduced tumor size in more than 50% of patients and was associated with fewer adverse reactions than other drugs that block the RET protein.