Non-small Cell Lung Cancer

• FDA approval · 2022-01-21
  FDA Approved: TABRECTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for TABRECTA (capmatinib) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2022-01-19
  FDA Approved: TAGRISSO — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Tagrisso (osimertinib) by AstraZeneca, resulting in updated labeling for the drug.

• FDA approval · 2021-11-10
  FDA Approved: GAVRETO — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Gavreto (pralsetinib) filed by Genentech, expanding its label for RET fusion–positive cancer…

• FDA approval · 2021-10-07
  FDA Approved: ZYKADIA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for ZYKADIA (ceritinib) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2021-09-24
  FDA Approved: ALUNBRIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ALUNBRIG (brigatinib) submitted by Takeda Pharmaceuticals America, Inc.

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• FDA approval · 2021-09-22
  FDA Approved: XALKORI — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XALKORI (crizotinib) submitted by Pfizer Laboratories Div Pfizer Inc, resulting in an approved u…

• FDA approval · 2021-09-03
  FDA Approved: ALECENSA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Alecensa (alectinib hydrochloride) submitted by Genentech, Inc., resulting in updated labeling f…

• FDA approval · 2021-08-19
  FDA Approved: ZYKADIA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for ZYKADIA (ceritinib) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2021-07-08
  FDA Approved: ERLOTINIB HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's Erlotinib Hydrochloride original application (ANDA214719), authorizing a generic Erlotinib hy…

• FDA approval · 2021-07-01
  FDA Approved: DOCETAXEL — Original Application (Gland Pharma Limited)

  FDA approves Gland Pharma Limited's generic docetaxel as an Original Application, adding a new generic option for cancer chemotherapy.

• FDA approval · 2021-05-28
  FDA Approved: LUMAKRAS — Original Application (Amgen Inc)

  FDA approves Lumakras (sotorasib) from Amgen in an original application for the treatment of adults with KRAS G12C-mutant non-small cell lun…

• FDA approval · 2021-05-21
  FDA Approved: RYBREVANT — Original Application (Janssen Biotech, Inc.)

  FDA approved RYBREVANT (amivantamab-vmjw) from Janssen Biotech, Inc. for adults with metastatic non-small cell lung cancer with EGFR exon 20…

• FDA approval · 2021-05-10
  FDA Approved: ERLOTINIB HYDROCHLORIDE — Original Application (Novadoz Pharmaceuticals LLC)

  The FDA approved the original ANDA for erlotinib hydrochloride (generic) from Novadoz Pharmaceuticals LLC, making a generic version availabl…

• FDA approval · 2021-05-07
  FDA Approved: MEKINIST — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Mekinist (trametinib) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2021-03-03
  FDA Approved: LORBRENA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Lorlatinib (LORBRENA) filed by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2021-02-03
  FDA Approved: TEPMETKO — Original Application (EMD Serono, Inc.)

  The FDA approves Tepmetko (tepotinib hydrochloride) under an original NDA for adults with metastatic non-small cell lung cancer harboring ME…

• FDA approval · 2021-01-29
  FDA Approved: ALECENSA — Supplemental Application (Genentech, Inc.)

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

• FDA approval · 2021-01-14
  FDA Approved: DOCETAXEL — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma Pharmaceuticals USA Inc.'s original application for generic docetaxel. Docetaxel is a chemotherapy agent used to treat mu…

• FDA approval · 2020-12-11
  FDA Approved: GEMCITABINE — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' generic gemcitabine hydrochloride under an original ANDA.

• FDA approval · 2020-12-09
  FDA Approved: TAGRISSO — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for TAGRISSO (osimertinib) submitted by AstraZeneca Pharmaceuticals LP.

• FDA approval · 2020-11-09
  FDA Approved: ERLOTINIB — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's original ANDA for erlotinib, providing a generic version of the cancer drug.

• FDA approval · 2020-10-06
  FDA Approved: GEMCITABINE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for gemcitabine from Fresenius Kabi USA, approving a generic gemcitabine product under ANDA 090799. …

• FDA approval · 2020-09-10
  FDA Approved: DOCETAXEL — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for a generic docetaxel product (docetaxel anhydrous) from Mylan Institutional LLC.

• FDA approval · 2020-09-04
  FDA Approved: GAVRETO — Original Application (Genentech, Inc.)

  The FDA approved Gavreto (pralsetinib) from Genentech as an original application for treating metastatic RET fusion-positive cancers, includ…

• FDA approval · 2020-08-21
  FDA Approved: PEMETREXED — Original Application (Teva Pharmaceuticals, Inc.)

  The FDA approved Teva Pharmaceuticals' original application for pemetrexed, a chemotherapy agent indicated for non-small cell lung cancer an…