Non-small Cell Lung Cancer

• FDA label_change · 2026-02-26
  FDA Approved: ENSACOVE — Supplemental Application (Xcovery Holdings, Inc.)

  FDA approved a supplemental application for ENSACOVE (ensartinib) to update the labeling.

• CLINICAL_TRIALS label_change · 2025-09-26
  Clinical Trial Update: A Study on Using SFRT With Standard Treatment for Oligoprogressive NSCLC [Phase 2]

  This Phase 2 clinical trial investigates SFRT with standard treatment for oligoprogressive non-small cell lung cancer and is currently recru…

• FDA label_change · 2024-08-19
  FDA Approved: RYBREVANT — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for Rybrevant (amivantamab-vmjw) submitted by Janssen Biotech, Inc.

• FDA label_change · 2024-06-12
  FDA Approved: RETEVMO — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for RETEVMO (selpercatinib) from Eli Lilly, indicating an update to the drug’s labeling. The action …

• FDA label_change · 2023-08-09
  FDA Approved: GAVRETO — Supplemental Application (Genentech, Inc.)

  Genentech filed a supplemental application for Gavreto (pralsetinib) with the FDA. The action seeks a label update that could expand indicat…

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• FDA label_change · 2023-03-17
  FDA Approved: LUMAKRAS — Supplemental Application (Amgen Inc)

  FDA approved a supplemental application for LUMAKRAS (sotorasib) from Amgen, resulting in a labeling update related to the drug.

• FDA label_change · 2022-10-21
  FDA Approved: TAGRISSO — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Tagrisso (osimertinib) from AstraZeneca, resulting in changes to its labeling.

• FDA label_change · 2021-12-03
  FDA Approved: MEKINIST — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for MEKINIST (trametinib) from Novartis Pharmaceuticals Corporation. This action updates the dru…

• FDA label_change · 2021-05-05
  FDA Approved: IRESSA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for IRESSA (gefitinib) from AstraZeneca, updating the drug’s labeling.

• FDA label_change · 2016-10-04
  FDA Approved: GILOTRIF — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Gilotrif (afatinib) submitted by Boehringer Ingelheim, updating labeling for the drug.

• FDA label_change · 2013-06-26
  FDA Approved: DOCETAXEL — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for docetaxel, resulting in changes to the product labeling. The changes may include updates to indi…