Systemic Mastocytosis
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2026-04-24Clinical Trial Update: (PATHFINDER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients With Advanced Systemic Mastocytosis [Phase 2]
Phase 2 PATHFINDER study evaluating avapritinib in advanced systemic mastocytosis and related subtypes has completed with results posted, as…
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CLINICAL_TRIALS trial_result · 2026-04-24Clinical Trial Update: (Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis [Phase 2]
Bezuclastinib is being studied in a Phase 2 trial for advanced systemic mastocytosis and related subtypes; recruitment is ongoing.
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CLINICAL_TRIALS research · 2026-04-20Clinical Trial Update: Screening Study for KIT D816V Mutated Mast Cell Disease in Select Populations
A screening study sponsored by Blueprint Medicines is evaluating KIT D816V-mutated clonal mast cell disease in select populations. The study…
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CLINICAL_TRIALS trial_result · 2026-03-31Clinical Trial Update: Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis [Phase 3]
Phase 3 trial evaluating denosumab for osteoporosis associated with systemic mastocytosis has completed.
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CLINICAL_TRIALS trial_result · 2026-03-09Clinical Trial Update: Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
The document reports expanded access for Bezuclastinib to patients with nonadvanced or advanced systemic mastocytosis.
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CLINICAL_TRIALS research · 2026-03-04Clinical Trial Update: (Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis [Phase 2]
Phase 2 clinical trial update evaluating CGT9486 vs placebo in indolent or smoldering systemic mastocytosis. The study is currently active b…
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CLINICAL_TRIALS research · 2026-02-09Clinical Trial Update: Avapritinib Rollover Study [Phase 4]
A Phase 4 rollover study of avapritinib is currently recruiting for systemic mastocytosis, sponsored by Blueprint Medicines.
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CLINICAL_TRIALS trial_result · 2026-01-28Clinical Trial Update: Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies [Phase 1]
A Phase 1 trial evaluating flotetuzumab for relapsed or refractory CD123-positive hematologic malignancies has completed, providing initial …
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EMA approval · 2026-01-14EMA Authorised: Rydapt (Midostaurin) — Novartis Europharm Ltd
The European Medicines Agency authorised Rydapt (midostaurin) for additional indications in acute myeloid leukemia and systemic mastocytosis…
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CLINICAL_TRIALS trial_result · 2025-09-22Clinical Trial Update: Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis
A completed clinical trial studied thalidomide for relapsed or progressive systemic mastocytosis. The update does not provide trial results.
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CLINICAL_TRIALS research · 2025-08-26Clinical Trial Update: Mastocytosis From Pediatric Age to Adulthood: Local Registry of Cutaneous and Systemic Mastocytosis
A patient registry study tracking Cutaneous Mastocytosis and Systemic Mastocytosis from pediatric age to adulthood, currently recruiting.
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CLINICAL_TRIALS trial_result · 2025-04-10Clinical Trial Update: Study of Elenestinib (BLU-263) in Advanced Systemic Mastocytosis (AdvSM) and and Other KIT Altered Hematologic Malignancies [Phase 1]
Elenestinib (BLU-263) in a Phase 1 study for Advanced Systemic Mastocytosis and KIT-altered hematologic malignancies has been terminated.
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CLINICAL_TRIALS research · 2025-04-04Clinical Trial Update: Quality of Life and Disease-related Symptoms in Individuals With Systemic Mastocytosis
Clinical trial update on quality of life and disease-related symptoms in people with systemic mastocytosis; the trial is currently active bu…
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FDA approval · 2025-03-20FDA Approved: IMATINIB MESYLATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for imatinib mesylate (Teva) under an ANDA, authorizing continued regulatory approval for this gener…
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FDA approval · 2025-01-08FDA Approved: IMATINIB MESYLATE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental ANDA for Imatinib Mesylate (Chartwell RX, LLC), enabling marketing of a generic version of the cancer drug.
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FDA approval · 2023-08-16FDA Approved: IMATINIB — Supplemental Application (Dr.Reddy's Laboratories Inc)
FDA approved a supplemental application for Imatinib from Dr. Reddy's Laboratories Inc, resulting in regulatory approval for a change to the…
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FDA approval · 2023-05-22FDA Approved: RYDAPT — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for RYDAPT (midostaurin) submitted by Novartis Pharmaceuticals Corporation. The approval updates…
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FDA approval · 2023-03-09FDA 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…
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CLINICAL_TRIALS trial_result · 2022-11-10Clinical Trial Update: GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies [Phase 1, Phase 2]
Phase 1/2 trial of GTB-3550 Tri-Specific Killer Engager (TriKE) for high-risk hematologic malignancies has been terminated; results posted i…
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CLINICAL_TRIALS trial_result · 2021-06-29Clinical Trial Update: A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies [Phase 1, Phase 2]
A Phase 1/2 study of oral AMN107 (imatinib) in adults with chronic myeloid leukemia and other hematologic malignancies has completed enrollm…
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FDA approval · 2021-06-16FDA Approved: AYVAKIT — Supplemental Application (Blueprint Medicines Corporation)
FDA approved a supplemental application for AYVAKIT (avapritinib) submitted by Blueprint Medicines Corporation, signaling agency action rela…
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FDA approval · 2021-04-20FDA Approved: RYDAPT — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for RYDAPT (midostaurin) from Novartis, updating the regulatory status of the product.
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FDA approval · 2020-01-09FDA Approved: IMATINIB MESYLATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for imatinib mesylate from Teva Pharmaceuticals USA, Inc., under ANDA204285.
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CLINICAL_TRIALS trial_result · 2019-05-06Clinical Trial Update: Dasatinib as Therapy for Myeloproliferative Disorders (MPDs) [Phase 2]
Phase 2 trial evaluating dasatinib for myeloproliferative disorders; the study has completed and results were posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-01-29Clinical Trial Update: Brentuximab Vedotin in Treating Patients With Advanced Systemic Mastocytosis or Mast Cell Leukemia [Phase 2]
Phase 2 trial evaluating Brentuximab vedotin in advanced systemic mastocytosis or mast cell leukemia has completed and results have been pos…