Non-small Cell Lung Cancer

• FDA approval · 2024-12-18
  FDA Approved: ENSACOVE — Original Application (Xcovery Holdings, Inc.)

  FDA approved ENSARTINIB (ENSACOVE) from Xcovery Holdings in an original application for adults with ALK-positive metastatic non-small cell l…

• FDA approval · 2024-12-18
  FDA Approved: RETEVMO — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for RETEVMO (selpercatinib) by Eli Lilly, expanding its approved indications for RET fusion-positive…

• EMA approval · 2024-12-17
  EMA Authorised: Vizimpro (dacomitinib monohydrate) — Pfizer Europe MA EEIG

  The European Medicines Agency authorised Vizimpro (dacomitinib monohydrate) for non-small cell lung cancer, with Pfizer Europe MA EEIG as th…

• EMA approval · 2024-12-03
  EMA Authorised: Lumykras (sotorasib) — Amgen Europe B.V.

  The EMA authorised Lumykras (sotorasib) for non-small-cell lung cancer. The decision includes a conditional approval.

• FDA approval · 2024-11-15
  FDA Approved: PEMRYDI RTU — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for PEMRYDI RTU, a ready-to-use formulation of pemetrexed disodium, developed by Amneal Pharmace…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2024-09-30
  FDA Approved: LUMAKRAS — Supplemental Application (Amgen Inc)

  FDA approved Amgen's supplemental application for LUMAKRAS (sotorasib), updating the labeling to reflect the information approved in the sub…

• FDA approval · 2024-09-25
  FDA Approved: TAGRISSO — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Tagrisso (osimertinib) from AstraZeneca Pharmaceuticals LP. This action updates the labeling…

• FDA approval · 2024-09-24
  FDA Approved: GEMCITABINE HYDROCHLORIDE — Supplemental Application (Teyro Labs Private Limited)

  FDA approved a supplemental application for Gemcitabine hydrochloride from Teyro Labs Private Limited, authorizing continued approval of thi…

• FDA approval · 2024-09-19
  FDA Approved: RYBREVANT — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for RYBREVANT (amivantamab-vmjw) from Janssen Biotech, Inc.

• FDA approval · 2024-08-19
  FDA Approved: LAZCLUZE — Original Application (Janssen Biotech, Inc.)

  FDA approved Lazertinib (LAZCLUZE) from Janssen Biotech, Inc. as the original application NDA for adult patients with non-small cell lung ca…

• EMA approval · 2024-07-31
  EMA Authorised: Taxotere (docetaxel) — Sanofi Winthrop Industrie

  The EMA authorised Taxotere (docetaxel) for multiple cancer indications including head and neck cancer, non-small cell lung cancer, gastric …

• FDA approval · 2024-06-28
  FDA Approved: AXTLE — Original Application (Avyxa Pharma, LLC)

  FDA approved the original application for AXTLE (pemetrexed) by Avyxa Pharma, LLC, for treatment of malignant pleural mesothelioma and non-s…

• FDA approval · 2024-06-21
  FDA Approved: KRAZATI — Supplemental Application (Mirati Therapeutics, Inc)

  The FDA approved a supplemental application for KRAZATI (adagrasib) submitted by Mirati Therapeutics, Inc.

• FDA approval · 2024-06-14
  FDA Approved: PEMETREXED — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for a generic pemetrexed disodium, enabling manufacturing and marketing of this ge…

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

  FDA approved a supplemental application for RETEVMO (selpercatinib) from Eli Lilly and Company.

• FDA approval · 2024-05-24
  FDA Approved: ERLOTINIB — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' original application for Erlotinib (ERLOTINIB), enabling a generic version of the cancer drug to be…

• FDA approval · 2024-05-10
  FDA Approved: CISPLATIN — Original Application (Apotex Corp.)

  FDA approved the original application for cisplatin from Apotex Corp., enabling the generic version to be marketed in the United States.

• FDA approval · 2024-04-29
  FDA Approved: TAGRISSO — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for TAGRISSO (osimertinib) submitted by AstraZeneca Pharmaceuticals LP. The approval updates the…

• FDA approval · 2024-04-18
  FDA Approved: ALECENSA — Supplemental Application (Genentech, Inc.)

  FDA approves a supplemental application for Alecensa (alectinib hydrochloride) submitted by Genentech, Inc.

• FDA approval · 2024-04-10
  FDA Approved: RETEVMO — Original Application (Eli Lilly and Company)

  The FDA approved the original application for selpercatinib (RETEVMO) from Eli Lilly and Company. It is approved for RET fusion-positive non…

• FDA approval · 2024-04-10
  FDA Approved: RETEVMO — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for RETEVMO (selpercatinib) from Eli Lilly, expanding its labeled indications for RET fusion–positiv…

• FDA approval · 2024-03-14
  FDA Approved: TABRECTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tabrecta (capmatinib) from Novartis Pharmaceuticals Corporation. The action relates to Tabrecta'…

• FDA approval · 2024-03-01
  FDA Approved: RYBREVANT — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for Rybrevant (amivantamab-vmjw) from Janssen Biotech, Inc.; the snippet does not specify the ne…

• FDA approval · 2024-02-29
  FDA Approved: PEMETREXED — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for a generic pemetrexed disodium product from BluePoint Laboratories.

• FDA approval · 2024-02-29
  FDA Approved: PEMETREXED — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for pemetrexed disodium (Pemetrexed) submitted by BluePoint Laboratories.