Gastrointestinal Stromal Tumor

• CLINICAL_TRIALS trial_result · 2023-07-07
  Clinical Trial Update: A Randomised Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST) [Phase 2]

  Phase 2 randomized trial assessing alternating imatinib with regorafenib versus imatinib alone as first-line therapy for advanced gastrointe…

• FDA approval · 2023-03-09
  FDA Approved: AYVAKIT — Supplemental Application (Blueprint Medicines Corporation)

  FDA approved a supplemental application for AYVAKIT (avapritinib) from Blueprint Medicines Corporation to update the product label (includin…

• FDA approval · 2023-01-31
  FDA Approved: IMATINIB MESYLATE — Supplemental Application (BluePoint Laboratories)

  FDA approves a supplemental application for Imatinib Mesylate from BluePoint Laboratories under an ANDA, confirming approval of a generic pr…

• FDA approval · 2022-12-29
  FDA Approved: QINLOCK — Supplemental Application (Deciphera Pharmaceuticals, LLC)

  FDA approved a supplemental application for QINLOCK (ripretinib) submitted by Deciphera Pharmaceuticals, LLC.

• CLINICAL_TRIALS trial_result · 2022-08-18
  Clinical Trial Update: Nivolumab With or Without Ipilimumab in Treating Patients With Gastrointestinal Stromal Tumor That Is Metastatic or Cannot Be Removed by Surgery [Phase 2]

  Phase 2 trial evaluating nivolumab with or without ipilimumab in metastatic or unresectable gastrointestinal stromal tumor (GIST).

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• FDA approval · 2022-06-21
  FDA Approved: IMATINIB MESYLATE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved an original application for imatinib mesylate (Upsher-Smith Laboratories) as a generic product. The approval supports its use f…

• FDA approval · 2022-04-11
  FDA Approved: SUNITINIB MALATE — Original Application (Dr.Reddys Laboratories Inc)

  FDA approved a generic version of sunitinib malate (SUNITINIB MALATE) from Dr. Reddy's Laboratories Inc under Original Application.

• FDA approval · 2021-12-06
  FDA Approved: SUNITINIB MALATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved a generic version of sunitinib malate submitted by Mylan Pharmaceuticals Inc., for use in cancer indications shared with the re…

• FDA approval · 2021-08-30
  FDA Approved: SUTENT — Supplemental Application (U.S. Pharmaceuticals)

  The FDA approved a supplemental application for Sutent (sunitinib malate) submitted by U.S. Pharmaceuticals, enabling an updated indication …

• FDA approval · 2021-08-16
  FDA Approved: SUNITINIB MALATE — Original Application (NorthStar RxLLC)

  FDA approved the original application for sunitinib malate, authorizing a generic version of the cancer drug from NorthStar RxLLC.

• CLINICAL_TRIALS trial_result · 2021-07-15
  Clinical Trial Update: Ph II CABOGIST in GIST [Phase 2]

  Phase II trial update for CABOGIST in metastatic gastrointestinal stromal tumor has completed.

• FDA approval · 2021-06-17
  FDA Approved: QINLOCK — Supplemental Application (Deciphera Pharmaceuticals, LLC)

  The FDA approved a supplemental application for QINLOCK (ripretinib) submitted by Deciphera Pharmaceuticals.

• FDA approval · 2021-06-16
  FDA Approved: AYVAKIT — Supplemental Application (Blueprint Medicines Corporation)

  FDA approved a supplemental application for AYVAKIT (avapritinib) submitted by Blueprint Medicines Corporation, signaling agency action rela…

• CLINICAL_TRIALS trial_result · 2021-05-14
  Clinical Trial Update: (VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST [Phase 3]

  Phase 3 trial comparing avapritinib to regorafenib in locally advanced unresectable or metastatic GIST has completed with results posted.

• CLINICAL_TRIALS trial_result · 2021-05-10
  Clinical Trial Update: A Phase II Trial of the DNA Methyl Transferase Inhibitor, Guadecitabine (SGI-110), in Children and Adults With Wild Type GIST,Pheochromocytoma and Paraganglioma Associated With Succinate Dehydrogenase Deficiency and HLRCC-associated Kidney Cancer [Phase 2]

  A Phase II trial of the DNA methyltransferase inhibitor guadecitabine (SGI-110) in children and adults with wild-type GIST, paraganglioma, p…

• FDA approval · 2021-03-25
  FDA Approved: IMATINIB — Supplemental Application (Dr.Reddy's Laboratories Inc)

  FDA approved a supplemental application for imatinib from Dr. Reddy's Laboratories, supporting an update to the drug's labeling under the AN…

• CLINICAL_TRIALS trial_result · 2021-02-18
  Clinical Trial Update: NIR Fluorescence Imaging With ICG for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours [Phase 2, Phase 3]

  A clinical trial update on NIR fluorescence imaging with ICG for intraoperative identification of gastrointestinal stromal tumors (GIST) acr…

• CLINICAL_TRIALS trial_result · 2021-01-22
  Clinical Trial Update: Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST [Phase 3]

  A randomized Phase 3 trial evaluating crenolanib in GIST patients with the D842V PDGFRA mutation.

• CLINICAL_TRIALS trial_result · 2021-01-20
  Clinical Trial Update: Efficacy and Safety of PD-0332991 in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib [Phase 2]

  Phase 2 trial evaluating the efficacy and safety of PD-0332991 (palbociclib) in advanced gastrointestinal stromal tumors refractory to imati…

• CLINICAL_TRIALS trial_result · 2020-09-10
  Clinical Trial Update: Treatment of Patients With Everolimus and Imatinib Mesylate Who Have Progressive Gastro Intestinal Stromal Tumors (GIST) and Are Resistant to Imatinib Mesylate [Phase 4]

  Phase 4 trial update assessing the combination of everolimus and imatinib for progressive gastrointestinal stromal tumors resistant to imati…

• FDA approval · 2020-08-10
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for GLEEVEC (imatinib mesylate) from Novartis, approving changes to the product labeling based o…

• FDA approval · 2020-07-23
  FDA Approved: IMATINIB MESYLATE — Original Application (BluePoint Laboratories)

  FDA approved imatinib mesylate as an original-application generic drug for BluePoint Laboratories.

• CLINICAL_TRIALS trial_result · 2020-07-13
  Clinical Trial Update: L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors [Phase 3]

  Phase 3 clinical trial comparing L-carnitine to placebo for treating muscle cramps after imatinib in patients with gastrointestinal stromal …

• CLINICAL_TRIALS trial_result · 2020-06-16
  Clinical Trial Update: Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery [Phase 2]

  A Phase 2 trial evaluating nivolumab with or without ipilimumab in metastatic or unresectable sarcoma shows results from a completed study.

• FDA approval · 2020-05-15
  FDA Approved: QINLOCK — Original Application (Deciphera Pharmaceuticals, LLC)

  The FDA approved Qinlock (ripretinib) by original application for the treatment of adults with unresectable or metastatic gastrointestinal s…