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Journal Articles

Impact of Venetoclax Exposure on Clinical Efficacy and Safety in Biomarker-Selected Patients with Relapsed or Refractory Multiple Myeloma: Implication for Dose Selection

Mohamed A Badawi, Sheryl Coppola, Doerthe Eckert, Sathej Gopalakrishnan, Eva Doelger, Edyta Dobkowska, Shaji K Kumar, Weize Huang, Rajeev Menon, Ahmed Hamed Salem

Blood (2022) 140 (Supplement 1): 4281–4282.

https://doi.org/10.1182/blood-2022-166584

Published: 2022

Journal Articles

Exposure-Response Analysis Supports a Lower Dose of Venetoclax in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma Patients When Combined with Daratumumab and Dexamethasone

Mohamed A Badawi, Benjamin Engelhardt, Jesus Badillo, Ahmed Abbas Suleiman, Leanne Lash Fleming, Yan Luo, Jonathan L. Kaufman, Nizar Jacques Bahlis, Rajeev Menon, Ahmed Hamed Salem

Blood (2022) 140 (Supplement 1): 10122–10123.

https://doi.org/10.1182/blood-2022-166429

Published: 2022

Journal Articles

Efficacy of venetoclax plus rituximab for relapsed CLL: 5-year follow-up of continuous or limited- duration therapy

Shuo Ma, John F. Seymour, Danielle M. Brander, Thomas J. Kipps, Michael Y. Choi, Mary Ann Anderson, Kathryn Humphrey, Abdullah Al Masud, John Pesko, Ruby Nandam, Ahmed Hamed Salem, Brenda Chyla, Jennifer Arzt, Amanda Jacobson, Su Young Kim, Andrew W. Roberts

Blood (2021) 138 (10): 836–846.

https://doi.org/10.1182/blood.2020009578

Published: 2021

Includes: Supplemental data

Journal Articles

Venetoclax Crosses the Blood Brain Barrier: A Pharmacokinetic Analysis of the Cerebrospinal Fluid in Pediatric Leukemia Patients

Ahmed Hamed Salem, PhD FCP, Mohamed A Badawi, PhD, Andrew E. Place, MDPhD, Tammy L. Palenski, PhD, Richard Arrendale, PhD, Su Young Kim, Sara Federico, MD, Todd M. Cooper, DO, Rajeev Menon, PhD

Blood (2020) 136 (Supplement 1): 30–31.

https://doi.org/10.1182/blood-2020-137197

Published: 2020

Journal Articles

Venetoclax Exposure-Efficacy and Exposure-Safety Relationships in Subjects with Treatment-Naïve Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

Doerthe Eckert, MSc, Deanna Brackman, PhD, Rajeev Menon, PhD, Ahmed Hamed Salem, PhD FCP, Jalaja Potluri, MD, B. Douglas Smith, MD, Andrew H. Wei, John Hayslip, MD MSCR, Dale Miles, PhD, Sven Mensing, PhD, Sathej Gopalakrishnan, PhD, Jiuhong Zha, PhD

Blood (2020) 136 (Supplement 1): 52.

https://doi.org/10.1182/blood-2020-136425

Published: 2020

Journal Articles

Proposed Scheme for Dosing Venetoclax in Pediatric Patients with Relapsed/Refractory Acute Myeloid Leukemia: Analysis of Developmental Pharmacokinetics and Exposure-Response Relationships

Mohamed A Badawi, PhD, Sathej Gopalakrishnan, PhD, Benjamin Engelhardt, PhD, Tammy L. Palenski, PhD, Su Young Kim, Seth E. Karol, MD, Jeffrey E. Rubnitz, MD, Rajeev Menon, PhD, Ahmed Hamed Salem, PhD FCP

Blood (2020) 136 (Supplement 1): 11–12.

https://doi.org/10.1182/blood-2020-139593

Published: 2020

Journal Articles

A Phase 1b Study Evaluating the Safety and Efficacy of Venetoclax As Monotherapy or in Combination with Azacitidine for the Treatment of Relapsed/Refractory Myelodysplastic Syndrome

Blood (2019) 134 (Supplement_1): 565.

https://doi.org/10.1182/blood-2019-124994

Published: 2019

Journal Articles

Ibrutinib (Ibr) Plus Venetoclax (Ven) for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Results from the MRD Cohort of the Phase 2 CAPTIVATE Study

Blood (2019) 134 (Supplement_1): 35.

https://doi.org/10.1182/blood-2019-121424

Published: 2019

Journal Articles

Phase I/II Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Dexamethasone As Targeted Therapy for Patients with t(11;14) Relapsed/Refractory Multiple Myeloma

Jonathan L. Kaufman, MD, Cristina Gasparetto, MD, Fredrik H. Schjesvold, MD PhD, Philippe Moreau, MD, Cyrille Touzeau, MD, Thierry Facon, MD, Lawrence H. Boise, PhD, Stefanie Alzate, MSc, Tammy Macartney, John Pesko, PhD, Ahmed Hamed Salem, PhD FCP, Jeremy A. Ross, PhD, Wan-Jen Hong, MD, Paulo C. Maciag, MD PhD, James M. Pauff, MD PhD, Shaji K. Kumar, MD

Blood (2019) 134 (Supplement_1): 926.

https://doi.org/10.1182/blood-2019-125871

Published: 2019

Journal Articles

Safety and Efficacy of Venetoclax in Combination with Navitoclax in Adult and Pediatric Relapsed/Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

Blood (2019) 134 (Supplement_1): 285.

https://doi.org/10.1182/blood-2019-126977

Published: 2019

Journal Articles

Venetoclax in Combination with High-Dose Chemotherapy Is Active and Well-Tolerated in Children with Relapsed or Refractory Acute Myeloid Leukemia

Seth E Karol, MD, Thomas Alexander, MDMPH, Amit Budraja, PhD, Stanley Pounds, PhD, Kristin E Canavera, PhD, Lei Wang, MS, Joshua Wolf, MBBS, PhD, Jeffery M. Klco, MD PhD, Ahmed Hamed Salem, PhD FCP, Tammy Palenski, PhD, Norman J. Lacayo, MD, Ching-Hon Pui, MD, Joseph T. Opferman, PhD, Jeffrey Rubnitz, MD PhD

Blood (2019) 134 (Supplement_1): 178.

https://doi.org/10.1182/blood-2019-127716

Published: 2019

Journal Articles

Safety, Efficacy, and PK of the BCL2 Inhibitor Venetoclax in Combination with Chemotherapy in Pediatric and Young Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia: Phase 1 Study

Seth E Karol, MD, Todd M Cooper, DO, Henrique Bittencourt, Lia Gore, MD, Maureen M O'Brien, MD, Christopher Fraser, MD, Marion Gambart, MD, Gunnar Cario, MD PhD, Christian Michel Zwaan, MD PhD, Jean-Pierre Bourquin, MD PhD, Mignon L. Loh, MD, Hubert Caron, MD PhD, Betty Prine, Ahmed Hamed Salem, PhD FCP, Kristina Unnebrink, Bo Tong, PhD, Tammy Palenski, PhD, Andrew E. Place, MD PhD

Blood (2019) 134 (Supplement_1): 2649.

https://doi.org/10.1182/blood-2019-129805

Published: 2019

Journal Articles

First Analysis from a Phase 1/2 Study of Venetoclax in Combination with Daratumumab and Dexamethasone, +/- Bortezomib, in Patients with Relapsed/Refractory Multiple Myeloma

Nizar Bahlis, MD, Rachid Baz, MD, Simon Harrison, MBBS, MRCP, FRCPath, FRACP, PhD, Hang Quach, MBBS, FRACP, FRCPA, MD, Shir-Jing Ho, MBBS, FRACP, FRCPA, MClinTrial Res, Annette Juul Vangsted, MD PhD, Philippe Moreau, MD, Simon Gibbs, FRACP, FRCPA, MBBS, Ahmed Hamed Salem, PhD FCP, Jeremy A. Ross, PhD, John Pesko, PhD, Sally Westrup, Jenny Vue, Paulo C. Maciag, MD PhD, Orlando F. Bueno, MD PhD, Jonathan L. Kaufman, MD

Blood (2019) 134 (Supplement_1): 925.

https://doi.org/10.1182/blood-2019-124407

Published: 2019

Journal Articles

Exposure-Response Analysis of Venetoclax in Combination with Hypomethylating Agents or Low-Dose Cytarabine in Elderly Patients with Newly Diagnosed Acute Myeloid Leukemia

Suresh Agarwal, PhD, Sathej Gopalakrishnan, PhD, Sven Mensing, PhD, Jalaja Potluri, MD, John Hayslip, Anna Friedel, Rajeev Menon, PhD, Ahmed Hamed Salem, PhD

Blood (2018) 132 (Supplement 1): 5239.

https://doi.org/10.1182/blood-2018-99-116790

Published: 2018

Journal Articles

Sustained Minimal Residual Disease Negativity Predicted in Chronic Lymphocytic Leukemia Patients Treated with Venetoclax Combination Therapy for 2 Years: an Integrated Mechanistic Analysis of Multiple Phase I and II Studies

Sathej Gopalakrishnan, PhD, Brenda Chyla, PhD, Sven Mensing, PhD, Rajeev Menon, PhD, Rod Humerickhouse, MD PhD, Walid Awni, PhD, Ahmed Hamed Salem, PhD, Kevin J. Freise, PhD

Blood (2017) 130 (Supplement 1): 4318.

https://doi.org/10.1182/blood.V130.Suppl_1.4318.4318

Published: 2017

Journal Articles

Do Statins Enhance the Anti-Cancer Activity of Venetoclax?

Andrew W. Roberts, MS, Tu Xu, PhD, Jia Jia, PhD MBA, Suresh Agarwal, MS, PhD RPh, Ahmed Hamed Salem, PhD, Richard J. Bellin, MS, Lloyd T. Lam, PhD, Joel D. Leverson, PhD

Blood (2017) 130 (Supplement 1): 1737.

https://doi.org/10.1182/blood.V130.Suppl_1.1737.1737

Published: 2017

Journal Articles

Phase 1/2 Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Venetoclax in Japanese Subjects with Chronic Lymphocytic Leukemia

Kiyohiko Hatake, MD PhD, Kazuhito Yamamoto, MDPhD, Noriko Fukuhara, MD PhD, Shigeru Kusumoto, MD, Koji Izutsu, MD, PhD, Ilseung Choi, MD, Hirokazu Nagai, MD PhD, Hideyuki Honda, BS, Junjiro Saeki, MS, Andrew W. Roberts, MS, Paulo Maciag, MD PhD, Suresh Agarwal, MS, PhD RPh, Ahmed Hamed Salem, PhD, Kevin J. Freise, PhD, Tsukasa Kiriyama, PharmD, BSc, Kensei Tobinai, MD PhD

Blood (2017) 130 (Supplement 1): 5352.

https://doi.org/10.1182/blood.V130.Suppl_1.5352.5352

Published: 2017

Journal Articles

Promising efficacy and acceptable safety of venetoclax plus bortezomib and dexamethasone in relapsed/refractory MM

Philippe Moreau, Asher Chanan-Khan, Andrew W. Roberts, Amit B. Agarwal, Thierry Facon, Shaji Kumar, Cyrille Touzeau, Elizabeth A. Punnoose, Jaclyn Cordero, Wijith Munasinghe, Jia Jia, Ahmed Hamed Salem, Kevin J. Freise, Joel D. Leverson, Sari Heitner Enschede, Jeremy A. Ross, Paulo C. Maciag, Maria Verdugo, Simon J. Harrison

Blood (2017) 130 (22): 2392–2400.

https://doi.org/10.1182/blood-2017-06-788323

Published: 2017

Includes: Supplemental data

NARROW

Impact of Venetoclax Exposure on Clinical Efficacy and Safety in Biomarker-Selected Patients with Relapsed or Refractory Multiple Myeloma: Implication for Dose Selection

Exposure-Response Analysis Supports a Lower Dose of Venetoclax in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma Patients When Combined with Daratumumab and Dexamethasone

Efficacy of venetoclax plus rituximab for relapsed CLL: 5-year follow-up of continuous or limited- duration therapy

Venetoclax Crosses the Blood Brain Barrier: A Pharmacokinetic Analysis of the Cerebrospinal Fluid in Pediatric Leukemia Patients

Venetoclax Exposure-Efficacy and Exposure-Safety Relationships in Subjects with Treatment-Naïve Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

Proposed Scheme for Dosing Venetoclax in Pediatric Patients with Relapsed/Refractory Acute Myeloid Leukemia: Analysis of Developmental Pharmacokinetics and Exposure-Response Relationships

A Phase 1b Study Evaluating the Safety and Efficacy of Venetoclax As Monotherapy or in Combination with Azacitidine for the Treatment of Relapsed/Refractory Myelodysplastic Syndrome

Ibrutinib (Ibr) Plus Venetoclax (Ven) for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Results from the MRD Cohort of the Phase 2 CAPTIVATE Study

Phase I/II Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Dexamethasone As Targeted Therapy for Patients with t(11;14) Relapsed/Refractory Multiple Myeloma

Safety and Efficacy of Venetoclax in Combination with Navitoclax in Adult and Pediatric Relapsed/Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

Venetoclax in Combination with High-Dose Chemotherapy Is Active and Well-Tolerated in Children with Relapsed or Refractory Acute Myeloid Leukemia

Safety, Efficacy, and PK of the BCL2 Inhibitor Venetoclax in Combination with Chemotherapy in Pediatric and Young Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia: Phase 1 Study

First Analysis from a Phase 1/2 Study of Venetoclax in Combination with Daratumumab and Dexamethasone, +/- Bortezomib, in Patients with Relapsed/Refractory Multiple Myeloma

Exposure-Response Analysis of Venetoclax in Combination with Hypomethylating Agents or Low-Dose Cytarabine in Elderly Patients with Newly Diagnosed Acute Myeloid Leukemia

Sustained Minimal Residual Disease Negativity Predicted in Chronic Lymphocytic Leukemia Patients Treated with Venetoclax Combination Therapy for 2 Years: an Integrated Mechanistic Analysis of Multiple Phase I and II Studies

Do Statins Enhance the Anti-Cancer Activity of Venetoclax?

Phase 1/2 Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Venetoclax in Japanese Subjects with Chronic Lymphocytic Leukemia

Promising efficacy and acceptable safety of venetoclax plus bortezomib and dexamethasone in relapsed/refractory MM

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American Society of Hematology

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American Society of Hematology

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