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Lung Cancer
FDA Treatment Updates

Researchers are continually developing new treatment options for people diagnosed with lung cancer. Catch up on news and stories related to FDA treatment updates.

FDA Approves Jideytro (zidesamtinib) for ROS1-Positive NSCLC

July 27, 2026

FDA Updates Approval for Retevmo (selpercatinib) in RET-Positive NSCLC

July 15, 2026

FDA Expands Hernexeos (zongertinib) Approval for HER2-Mutated NSCLC

February 27, 2026

FDA Clears eyonis LCS for Use in Lung Cancer Screening

February 18, 2026

FDA Approves New Administration Method for Rybrevant (amivantamab)

December 18, 2025

FDA Approves Hyrnuo (sevabertinib) for HER2-Mutated NSCLC

November 20, 2025

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

October 3, 2025

FDA Approves Hernexeos (zongertinib) for HER2-Mutated NSCLC

August 8, 2025

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

July 7, 2025

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

June 24, 2025

FDA Approves Ibtrozi (taletrectinib) for ROS1-positive NSCLC

June 12, 2025

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

May 15, 2025

Ask the Experts: The Long Road to FDA Approvals

April 21, 2025

FDA Approves New Administration Method for Opdivo (nivolumab)

January 6, 2025

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

December 19, 2024

FDA Approves Imfinzi (durvalumab) as First-Line Therapy for Limited-Stage SCLC

December 6, 2024

FDA Approves Bizengri (zenocutuzumab-zbco) for Metastatic NRG1-Positive NSCLC

December 6, 2024

FDA Approves the Wearable Optune Lua Device for Metastatic NSCLC

October 16, 2024

FDA Approves Opdivo (nivolumab) for Resectable NSCLC

October 4, 2024

FDA Approves Tagrisso (osimertinib) for Stage 3 (III) NSCLC Following Chemoradiation

September 27, 2024

FDA Approves New Combination Therapy for People with Advanced EGFR+ NSCLC

September 20, 2024

FDA Approves New Administration Method for Tecentriq (atezolizumab)

September 16, 2024

FDA Approves New Treatment Combination for EGFR+ NSCLC

August 20, 2024

FDA Approves Neoadjuvant & Adjuvant Imfinzi (durvalumab) for Resectable NSCLC

August 19, 2024

FDA Approves Augtyro (repotrectinib) for Adults and Children with NTRK-Positive Solid Tumors

June 14, 2024

Fast-Tracking Innovation: The FDA’s Process for Approving New Cancer Therapies

May 2, 2024

FDA Approves Alecensa (alectinib) Following Tumor Resection for People with Early-Stage, ALK-Positive Non-Small Cell Lung Cancer

April 19, 2024

FDA Approves Rybrevant (amivantamab-vmjw) for Non-small Cell Lung Cancer with EGFR-Exon 20 Mutation

March 4, 2024

FDA Approves Tepmetko (tepotinib) for People with Metastatic Non-Small Cell Lung Cancer with MET-Exon 14 Mutation

February 16, 2024

FDA Approves Augtyro (repotrectinib) for People with Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer

November 16, 2023

FDA Approves New Treatment Regimen for Individuals Receiving Keytruda (pembrolizumab) for Resectable Non-Small Cell Lung Cancer

October 18, 2023

FDA Approves Combination Braftovi (encorafenib) and Mektovi (binimetinib) for Metastatic BRAF-Mutated Non-Small Cell Lung Cancer

October 18, 2023

FDA Approves Keytruda after Surgery and Chemotherapy for Early Stage Lung Cancers

January 27, 2023

FDA Approves Imjudo and Imfinzi in Combination with Chemotherapy for Patients with NSCLC

November 14, 2022

FDA Approves Libtayo in Combination with Chemotherapy for Patients with NSCLC Regardless of PD-L1 Status

November 9, 2022

FDA Approves First Targeted Therapy, Enhertu, for the Treatment of NSCLC With an Activating HER2 Mutation

August 15, 2022

FDA Approves New Combination Treatment Before Surgery for Early-Stage NSCLC

March 7, 2022

FDA Approvals: New Treatment Landscape in 2022

January 27, 2022

FDA Approves Tecentriq for Adjuvant Treatment of Non-Small Cell Lung Cancer

October 15, 2021

FDA Approves Exkivity for Advanced NSCLC with EGFR Exon 20 Insertion Mutation

September 16, 2021

Research into Acquired Drug Resistance in Patients with ALK+ NSCLC

June 10, 2021

FDA Approves Rybrevant as First Targeted Treatment for Patients with NSCLC with EGFR Exon 20 Insertion Mutations

May 24, 2021

GO2 for Lung Cancer Statement on Proposed FDA Actions on Menthol Cigarettes

April 29, 2021

FDA Updates Approval for Lobrena to First Line Treatment for Advanced NSCLC Patients with Changes in ALK

March 4, 2021

FDA approves new immunotherapy, Libtayo, for patients with metastatic NSCLC and high PD-L1

February 23, 2021

New Therapy for Small Cell Lung Cancer Patients: FDA Approval of COSELA (trilaciclib)

February 16, 2021

FDA Approves Tepmetko (tepotinib) for NSCLC with MET Exon 14 Skipping Mutations

February 4, 2021

FDA Approves Gavreto (pralsetinib) for the Treatment of Advanced NSCLC with Tumors Having Changes in RET

September 9, 2020

New FDA Approval for FoundationOne Liquid CDx Biomarker Testing

September 1, 2020

FDA Approval: Access to New Comprehensive Liquid Biopsy Biomarker Testing

August 10, 2020

FDA approves Zepzelca (lurbinectedin) for treatment of advanced SCLC

June 16, 2020

FDA Approves ramucirumab Plus erlotinib for First-Line Metastatic NSCLC

June 1, 2020

FDA Approves nivolumab Plus ipilimumab and Chemotherapy for First-Line Treatment of Metastatic NSCLC

May 27, 2020

FDA Approves brigatinib for ALK-positive Metastatic NSCLC

May 26, 2020

FDA Approves Tecentriq for First-Line Treatment of Metastatic NSCLC with High PD-L1 Expression

May 19, 2020

First FDA Approval of Combined Immunotherapy Treatment for NSCLC

May 15, 2020

FDA Approves Retevmo (selpercatinib) for Treatment of Advanced NSCLC

May 11, 2020

FDA Grants Accelerated Approval to Tabrecta (capmatinib) for Metastatic Non-small Cell Lung Cancer with a Change in MET

May 7, 2020

FDA Approves New First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

March 30, 2020

FDA Approves Tecentriq Plus Chemotherapy as a First-Line Treatment for Metastatic NSCLC

December 5, 2019

FDA Approves Genentech’s Rozlytrek (entrectinib) for ROS1 Non-Small Cell Lung Cancer (NSCLC) and NTRK-Driven Tumors

August 16, 2019

FDA Approves First-Line Treatment for NSCLC with PD-L1 Biomarker

April 12, 2019

FDA Approves Targeted Therapy for Solid Tumors with NTRK Gene

November 27, 2018

FDA Approves New Treatment for ALK+ NSCLC Patients

November 2, 2018

FDA Approves New Combination Treatment for NSCLC

October 31, 2018

New First-Line Treatment Approved for NSCLC with an EGFR Mutation

September 28, 2018

FDA Approves Tagrisso as First-line Treatment for NSCLC

April 19, 2018

FDA expands approval of Gilotrif (afatinib) for NSCLC

January 17, 2018

FDA expands approval of Gilotrif (afatinib) for NSCLC

January 17, 2018

FDA Approves and CMS Advances Coverage Decision for Test that Informs Lung Cancer Treatment Decisions

December 1, 2017

FDA Approves First-Line Treatment for NSCLC with ALK Biomarker

November 7, 2017

FDA Approves First Combination of Chemotherapy and Immunotherapy for Lung Cancer Patients

September 28, 2017