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Leukemia

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2. Axicabtagene ciloleucel (Idhifa) - acute myeloid leukemia (R/R AML)

Axicabtagene ciloleucel (Idhifa) - acute myeloid leukemia (R/R AML) Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after

2019 Health Canada - Drug and Health Product Register

3. Rituximab (Truxima) - Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia or Rheumatoid Arthritis

Rituximab (Truxima) - Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia or Rheumatoid Arthritis Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity

2019 Health Canada - Drug and Health Product Register

4. Gilteritinib (Xospata) - To treat patients who have relapsed or refractory acute myeloid leukemia (AML)

Gilteritinib (Xospata) - To treat patients who have relapsed or refractory acute myeloid leukemia (AML) Drug Approval Package: XOSPATA (gilteritinib) U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: XOSPATA (gilteritinib) Company: Astellas Pharma US, Inc. Application Number: 211349 Orig 1 Approval Date:11/28/2018 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter

2019 FDA - Drug Approval Package

5. Glasdegib (Daurismo) - To treat newly-diagnosed acute myeloid leukemia (AML) in adult patients

Glasdegib (Daurismo) - To treat newly-diagnosed acute myeloid leukemia (AML) in adult patients Drug Approval Package: DAURISMO (glasdegib) U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: DAURISMO (glasdegib) Company: Pfizer, Inc. Application Number: 210656 Approval Date: 11/21/2018 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF) FDA

2019 FDA - Drug Approval Package

6. Tisagenlecleucel (Kymriah) - for the treatment of pediatric and young adult patients 3 to 25 years with B-cell acute lymphoblastic leukemia (ALL)

Tisagenlecleucel (Kymriah) - for the treatment of pediatric and young adult patients 3 to 25 years with B-cell acute lymphoblastic leukemia (ALL) Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product

2019 Health Canada - Drug and Health Product Register

7. Calaspargase pegol-mknl (Asparlas) - To treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients

Calaspargase pegol-mknl (Asparlas) - To treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients Drug Approval Package: Asparlas U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: Asparlas Company: Servier Pharmaceuticals, LLC Application Number: 761102 Approval Date: 12/20/2018 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF

2019 FDA - Drug Approval Package

8. Gemtuzumab ozogamicin (Mylotarg) - Leukemia, Myeloid, Acute

Gemtuzumab ozogamicin (Mylotarg) - Leukemia, Myeloid, Acute 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 22 February 2018 EMA/155284/2018 Committee for Medicinal Products for Human Use (CHMP) Assessment report Mylotarg (...) balance 134 3.8. Conclusions 135 4. Recommendations 135 Assessment report EMA/155284/2018 Page 4/138 List of abbreviations Term Definition AAS Amino Acid Substitution AcBut (4-(4'acetylphenoxy)butanoic acid) ADA anti-drug antibody ADC antibody-drug conjugate ADE AraC/DNR/etoposide ADR adverse drug reaction AE adverse event ALFA Acute Leukemia French Association ALP alkaline phosphatase ALT alanine aminotransferase AML acute myeloid leukaemia ANC absolute neutrophil count APL acute promyelocytic

2018 European Medicines Agency - EPARs

9. Venetoclax (Venclexta) - chronic lymphocytic leukemia (CLL)

Venetoclax (Venclexta) - chronic lymphocytic leukemia (CLL) Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September

2018 Health Canada - Drug and Health Product Register

10. Duvelisib (Copiktra) - To treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma

Duvelisib (Copiktra) - To treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma Drug Approval Package: COPIKTRA (duvelisib) U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: COPIKTRA (duvelisib) Company: Verastem Inc. Application Number: 211155 Approval Date: 09/24/2018 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval

2018 FDA - Drug Approval Package

11. Ivosidenib (Tibsovo) - To treat patients with relapsed or refractory acute myeloid leukemia

Ivosidenib (Tibsovo) - To treat patients with relapsed or refractory acute myeloid leukemia Drug Approval Package: Tibsovo (ivosidenib) U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: Tibsovo (ivosidenib) Company: Agios Pharmaceuticals, Inc. Application Number: 211192 Approval Date: 07/20/2018 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF

2018 FDA - Drug Approval Package

12. Moxetumomab pasudotox-tdfk (Lumoxiti) - To treat hairy cell leukemia

Moxetumomab pasudotox-tdfk (Lumoxiti) - To treat hairy cell leukemia Drug Approval Package: LUMOXITI U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: LUMOXITI Company: AstraZeneca AB Application Number: 761104 Approval Date: 09/13/2018 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF) FDA Application Review Files (PDF) (PDF) (PDF) (PDF) (PDF

2018 FDA - Drug Approval Package

16. Management of relapsed or refractory chronic lymphocytic leukemia (CLL)

Management of relapsed or refractory chronic lymphocytic leukemia (CLL)

2017 DynaMed Plus

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