Non-small Cell Lung Cancer

• FDA approval · 2016-08-23
  FDA Approved: PACLITAXEL PACLITAXEL — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved the original application for a generic paclitaxel product, manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac…

• FDA approval · 2016-04-29
  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.

• FDA approval · 2016-03-11
  FDA Approved: XALKORI — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for XALKORI (crizotinib) submitted by Pfizer Laboratories Div Pfizer Inc, updating the product l…

• FDA approval · 2016-02-10
  FDA Approved: TAGRISSO — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Tagrisso (osimertinib) from AstraZeneca Pharmaceuticals LP, granting an additional approved use …

• FDA approval · 2016-01-26
  FDA Approved: GEMCITABINE — Supplemental Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' supplemental application for gemcitabine hydrochloride (gemcitabine), enabling continued producti…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• EMA approval · 2015-12-18
  EMA fast-tracks new oral treatment for non-small cell lung cancer

  EMA has fast-tracked an oral treatment for non-small cell lung cancer, indicating accelerated consideration for patients.

• FDA approval · 2015-12-11
  FDA Approved: ALECENSA — Original Application (Genentech, Inc.)

  FDA approved ALECENSA (alectinib hydrochloride) from Genentech under NDA208434 as an original application for the treatment of ALK-positive …

• FDA approval · 2015-11-13
  FDA Approved: TAGRISSO — Original Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved Tagrisso (osimertinib) in an Original Application for metastatic EGFR T790M mutation-positive non-small cell lung cancer af…

• FDA approval · 2015-09-14
  FDA Approved: XALKORI — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XALKORI (crizotinib) from Pfizer, expanding regulatory authorization for the drug.

• FDA approval · 2015-08-28
  FDA Approved: ERLOTINIB — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's erlotinib original application, making a generic version available for the same uses as the reference product. The appro…

• FDA approval · 2015-07-13
  FDA Approved: IRESSA — Original Application (AstraZeneca Pharmaceuticals LP)

  This record documents the original FDA approval of IRESSA (gefitinib) by AstraZeneca for non-small cell lung cancer.

• EMA approval · 2015-05-22
  New treatment option for patients with advanced lung cancer

  EMA announces a new treatment option for patients with advanced lung cancer, indicating a regulatory advancement for an additional therapy i…

• EMA approval · 2015-02-27
  Zykadia recommended for approval in advanced non small cell lung cancer

  The European Medicines Agency recommended approving Zykadia for use in adults with advanced non-small cell lung cancer.

• FDA approval · 2014-11-05
  FDA Approved: DOCETAXEL — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approves the original (ANDA) application for docetaxel generic produced by Dr. Reddy's Laboratories.

• FDA approval · 2014-08-26
  FDA Approved: XALKORI — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for XALKORI (crizotinib) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2014-08-11
  FDA Approved: ALIMTA — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ALIMTA (pemetrexed disodium) submitted by Eli Lilly and Company.

• FDA approval · 2014-07-10
  FDA Approved: DOCETAXEL — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira, Inc.'s supplemental application for Docetaxel.

• FDA approval · 2014-05-15
  FDA Approved: DOCETAXEL — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Docetaxel (Sanofi-Aventis U.S. LLC), indicating an approved modification to its labeling and…

• FDA approval · 2014-02-14
  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.

• FDA approval · 2013-10-07
  FDA Approved: XALKORI — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XALKORI (crizotinib) from Pfizer, expanding its labeled indications.

• FDA approval · 2013-09-13
  FDA Approved: XALKORI — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for XALKORI (crizotinib) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2013-09-12
  FDA Approved: ALIMTA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for ALIMTA (pemetrexed disodium) submitted by Eli Lilly and Company.

• FDA approval · 2013-07-12
  FDA Approved: GILOTRIF — Original Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved Gilotrif (afatinib) from Boehringer Ingelheim for patients with metastatic non-small cell lung cancer whose tumors have activat…

• FDA approval · 2013-03-13
  FDA Approved: ALIMTA — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ALIMTA (pemetrexed disodium) from Eli Lilly and Company, updating its labeling with addition…

• FDA approval · 2013-02-28
  FDA Approved: XALKORI — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XALKORI (crizotinib) from Pfizer Laboratories Div Pfizer Inc.