Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
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FDA approval · 2023-12-05FDA Approved: PHYRAGO — Original Application (Cycle Pharmaceuticals Ltd)
The FDA approved PHYRAGO (dasatinib) from Cycle Pharmaceuticals Ltd under an original application. Dasatinib is indicated for Philadelphia c…
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CLINICAL_TRIALS trial_result · 2023-10-27Clinical Trial Update: A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia [Phase 3]
A Phase 3 clinical trial comparing ponatinib to imatinib in adults with Philadelphia chromosome–positive acute lymphoblastic leukemia; resul…
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CLINICAL_TRIALS trial_result · 2022-10-12Clinical Trial Update: Ph+/Bcr-Abl+ ALL Imatinib and Nilotinib Rotational Study [Phase 2]
A phase 2 clinical trial evaluating rotational therapy with Imatinib and Nilotinib in Ph+ BCR-ABL+ acute lymphoblastic leukemia (ALL), compl…
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CLINICAL_TRIALS trial_result · 2022-06-13Clinical Trial Update: A Study of Ponatinib in Japanese Participants With Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL) [Phase 1, Phase 2]
Phase 1/2 trial update of ponatinib in Japanese patients with Chronic Myeloid Leukemia and Philadelphia chromosome-positive Acute Lymphoblas…
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CLINICAL_TRIALS trial_result · 2022-05-24Clinical Trial Update: Sapanisertib in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia [Phase 2]
Phase 2 clinical trial evaluating sapanisertib in adults with relapsed or refractory acute lymphoblastic leukemia; results were posted in Ma…
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FDA approval · 2022-02-18FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Tasigna (nilotinib) submitted by Novartis Pharmaceuticals Corporation. The approval updates aspe…
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CLINICAL_TRIALS trial_result · 2021-11-30Clinical Trial Update: Phase II Front-line Ponatinib in Adult Philadelphia+/BCR-ABL+ Acute Lymphoblastic Leukemia. [Phase 2]
Phase II study of front-line ponatinib in adults with Philadelphia-positive/BCR-ABL-positive acute lymphoblastic leukemia has completed.
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FDA approval · 2021-09-23FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for TASIGNA (nilotinib) from Novartis.
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FDA approval · 2020-12-08FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approves a supplemental application for Tasigna (nilotinib) submitted by Novartis Pharmaceuticals Corporation. This action pertains to a…
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CLINICAL_TRIALS trial_result · 2020-07-30Clinical Trial Update: Evaluation of Efficacy and Safety of Nilotinib in Combination With Chemotherapy in Elderly Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia [Phase 2]
Phase 2 trial evaluating the efficacy and safety of nilotinib in combination with chemotherapy for elderly patients with Philadelphia chromo…
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CLINICAL_TRIALS trial_result · 2020-01-29Clinical Trial Update: Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL) [Phase 2]
Phase 2 trial update for ponatinib in chronic myeloid leukemia and Philadelphia chromosome–positive acute lymphoblastic leukemia has complet…
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CLINICAL_TRIALS trial_result · 2019-01-30Clinical Trial Update: SCT in Ph Positive Acute Lymphoblastic Leukemia
This clinical trial update reports that the study investigating stem cell transplantation for Philadelphia chromosome-positive acute lymphob…
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FDA approval · 2018-11-15FDA Approved: DASATINIB — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for dasatinib submitted by Prasco Laboratories.
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CLINICAL_TRIALS research · 2018-07-30Clinical Trial Update: Tyrosine Kinase Inhibitors and Low Intensity Chemotherapy in Ph+ ALL
An update on a clinical trial evaluating tyrosine kinase inhibitors combined with low-intensity chemotherapy in Philadelphia chromosome-posi…
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FDA label_change · 2018-03-22FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for TASIGNA (nilotinib) from Novartis to update the drug's label.
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FDA approval · 2017-11-09FDA Approved: DASATINIB — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for dasatinib filed by Prasco Laboratories, resulting in updated labeling for this drug.
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CLINICAL_TRIALS trial_result · 2017-11-08Clinical Trial Update: TKI Therapy Based on Molecular Monitoring in Allogeneic-HSCT Recipients With Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia [Phase 2]
Phase 2 clinical trial update evaluating tyrosine kinase inhibitor therapy guided by molecular monitoring in allogeneic stem cell transplant…
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CLINICAL_TRIALS trial_result · 2017-08-08Clinical Trial Update: Entinostat And Imatinib Mesylate In Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia [Phase 1, Phase 2]
Phase 1/2 trial of entinostat plus imatinib mesylate in relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia; t…
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FDA approval · 2017-06-21FDA Approved: IMATINIB MESYLATE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved Mylan's original application for imatinib mesylate tablets, a generic version of Gleevec, for the same indications as the refer…
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CLINICAL_TRIALS trial_result · 2017-05-15Clinical Trial Update: Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML [Phase 1, Phase 2]
A completed Phase 1/2 clinical trial evaluating the use of nilotinib and imatinib after donor stem cell transplant in patients with acute ly…
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CLINICAL_TRIALS trial_result · 2017-02-23Clinical Trial Update: Efficacy Study of Imatinib Mesylate to Treat Philadelphia-Positive Acute Lymphocytic Leukemia [Phase 2]
Phase 2 efficacy study of imatinib mesylate for Philadelphia chromosome-positive acute lymphoblastic leukemia has been completed.
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FDA approval · 2016-09-27FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for Tasigna (nilotinib) from Novartis Pharmaceuticals Corporation, resulting in updated labeling…
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CLINICAL_TRIALS trial_result · 2016-09-05Clinical Trial Update: Dasatinib and Low Intensity Chemotherapy for Ph+ Acute Lymphoblastic Leukemia [Phase 2]
A phase 2 trial evaluating dasatinib with low-intensity chemotherapy for Philadelphia chromosome–positive acute lymphoblastic leukemia has c…
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FDA label_change · 2016-08-31FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for ICLUSIG (ponatinib hydrochloride) by Takeda Pharmaceuticals America, Inc., resulting in labe…
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FDA approval · 2016-06-10FDA Approved: DASATINIB — Original Application (Apotex Corp.)
FDA approved Apotex Corp.'s original generic application for dasatinib (DASATINIB). The approval provides a generic version of dasatinib for…