Mantle Cell Lymphoma
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CLINICAL_TRIALS trial_result · 2022-07-26Clinical Trial Update: A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma [Phase 3]
A Phase 3 trial evaluating the combination of ibrutinib with bendamustine and rituximab in newly diagnosed mantle cell lymphoma has complete…
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FDA approval · 2022-07-26FDA Approved: BORTEZOMIB — Original Application (Hospira, Inc.)
FDA approved Hospira's generic version of bortezomib for injection under ANDA208460, enabling a generic option for the same indications as t…
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FDA approval · 2022-07-26FDA Approved: BORTEZOMIB — Original Application (Dr.Reddy's Laboratories, Inc.)
FDA approval of Dr. Reddy's Laboratories' original ANDA for Bortezomib, enabling a generic version of the proteasome inhibitor.
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FDA approval · 2022-07-26FDA Approved: BORTEZOMIB — Original Application (BluePoint Laboratories)
FDA approved BluePoint Laboratories' original generic application for bortezomib, a proteasome inhibitor used to treat multiple myeloma and …
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CLINICAL_TRIALS trial_result · 2022-07-21Clinical Trial Update: Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma [Phase 2, Phase 3]
Phase 2/3 trial assessing ublituximab + umbralisib with or without bendamustine, and umbralisib alone, in previously treated non-Hodgkin lym…
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FDA label_change · 2022-06-30FDA Approved: LENALIDOMIDE — Supplemental Application (Dr. Reddy's Laboratories Inc.)
FDA approved a supplemental application for lenalidomide submitted by Dr. Reddy's Laboratories Inc., resulting in updated labeling for the d…
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CLINICAL_TRIALS trial_result · 2022-05-25Clinical Trial Update: Laboratory Treated T Cells in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, or Acute Lymphoblastic Leukemia [Phase 1, Phase 2]
Phase 1/2 trial evaluating laboratory-treated T cells in relapsed or refractory B-cell malignancies and acute lymphoblastic leukemia.
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FDA approval · 2022-05-11FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)
FDA approved a supplemental application for IMBRUVICA (ibrutinib) from Pharmacyclics LLC.
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FDA approval · 2022-05-11FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)
FDA approves a supplemental application for IMBRUVICA (ibrutinib) submitted by Pharmacyclics LLC. The document indicates FDA approval of the…
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CLINICAL_TRIALS trial_result · 2022-05-06Clinical Trial Update: ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies [Phase 1, Phase 2]
Phase 1/2 trial of acalabrutinib (ACP-196) in combination with pembrolizumab in hematologic malignancies has completed with results posted i…
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FDA approval · 2022-05-02FDA Approved: BORTEZOMIB — Original Application (Apotex Corp)
FDA approves Apotex Corp's original application for a generic Bortezomib product under ANDA205533.
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FDA approval · 2022-05-02FDA Approved: BORTEZOMIB — Original Application (Eugia US LLC)
The FDA approved the original application for a generic Bortezomib product from Eugia US LLC (ANDA212825).
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FDA approval · 2022-05-02FDA Approved: BORTEZOMIB — Original Application (Fresenius Kabi USA, LLC)
FDA approves Fresenius Kabi USA's generic bortezomib injection under Original Application. Indications include multiple myeloma and mantle c…
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FDA approval · 2022-05-02FDA Approved: BORTEZOMIB — Original Application (BluePoint Laboratories)
FDA approved a generic version of bortezomib under an Original Application (ANDA210824) by BluePoint Laboratories.
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FDA approval · 2022-05-02FDA Approved: BORTEZOMIB — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approved the original application for generic bortezomib by Zydus Pharmaceuticals USA Inc., enabling a generic version of the proteasome…
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CLINICAL_TRIALS withdrawal · 2022-04-29Clinical Trial Update: A Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma [Phase 3]
Phase 3 study of parsaclisib with bendamustine and rituximab for newly diagnosed mantle cell lymphoma has been withdrawn.
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CLINICAL_TRIALS trial_result · 2022-04-04Clinical Trial Update: Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma [Phase 1, Phase 2]
Clinical trial update for ONC201 in relapsed/refractory non-Hodgkin's lymphoma, including phase 1 and phase 2 cohorts; study status terminat…
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CLINICAL_TRIALS trial_result · 2022-02-10Clinical Trial Update: A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor [Phase 2]
A Phase 2 study of the investigational drug INCB050465 in relapsed or refractory Mantle Cell Lymphoma (with or without prior BTK inhibitor) …
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CLINICAL_TRIALS trial_result · 2022-02-04Clinical Trial Update: Bortezomib and Rituximab in Treating Patients With Mantle Cell Lymphoma Who Have Previously Undergone Stem Cell Transplantation [Phase 2]
A Phase 2 trial evaluated bortezomib and rituximab in mantle cell lymphoma patients who had prior stem cell transplantation; results have be…
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CLINICAL_TRIALS trial_result · 2022-01-28Clinical Trial Update: Bortezomib, Rituximab and Combination Chemotherapy in Treating Participants With Mantle Cell Lymphoma [Phase 1, Phase 2]
Phase 1/2 trial evaluating bortezomib, rituximab, and combination chemotherapy in mantle cell lymphoma.
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CLINICAL_TRIALS trial_result · 2022-01-05Clinical Trial Update: Obinutuzumab in Combination With Ibrutinib in Treating Patients With Relapsed Mantle Cell Lymphoma [Phase 2]
Phase 2 trial evaluating obinutuzumab with ibrutinib in relapsed/refractory mantle cell lymphoma has completed with posted results.
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CLINICAL_TRIALS trial_result · 2022-01-03Clinical Trial Update: Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects [Phase 2]
Phase 2 clinical trial update evaluating Chi-BEAC with auto-HSCT for aggressive lymphomas, reporting on efficacy and safety.
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CLINICAL_TRIALS trial_result · 2021-12-21Clinical Trial Update: Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma [Phase 1, Phase 2]
A phase 1/2 clinical trial investigates a genetically engineered lymphocyte therapy given after peripheral blood stem cell transplant in pat…
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CLINICAL_TRIALS trial_result · 2021-12-21Clinical Trial Update: Study of Zanubrutinib, Rituximab and Combination Chemotherapy in Newly-diagnosed Aggressive B-cell Non-Hodgkin Lymphoma [Phase 3]
Phase 3 clinical trial update investigating zanubrutinib with rituximab and/or combination chemotherapy for newly diagnosed aggressive B-cel…
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CLINICAL_TRIALS trial_result · 2021-12-13Clinical Trial Update: Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Mantle Cell Lymphoma [Phase 1, Phase 2]
A multi-phase (Phase 1/2) clinical trial evaluating IM19 CAR-T cells for relapsed/refractory mantle cell lymphoma is ongoing; status current…