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Article ; Online: FDA Approval Summary: Axicabtagene Ciloleucel for Second-Line Treatment of Large B-Cell Lymphoma.

Sharma, Poornima / Kasamon, Yvette L / Lin, Xue / Xu, Zhenzhen / Theoret, Marc R / Purohit-Sheth, Tejashri

Clinical cancer research : an official journal of the American Association for Cancer Research

2023 Volume 29, Issue 21, Page(s) 4331–4337

Abstract: In April 2022, the FDA approved axicabtagene ciloleucel (axi-cel) for adults with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Approval was based on ... ...

Abstract	In April 2022, the FDA approved axicabtagene ciloleucel (axi-cel) for adults with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Approval was based on ZUMA-7, a randomized (1:1), open-label trial in 359 patients with primary refractory LBCL (74%) or early relapse who were transplant candidates. The study compared a single course of axi-cel to standard therapy, consisting of chemoimmunotherapy followed by high-dose therapy and autologous hematopoietic stem cell transplantation (HSCT) in responding patients. Overall, 94% of the experimental arm received chimeric antigen receptor (CAR) T-cell product, and 35% of the control arm received on-protocol HSCT. The primary endpoint was event-free survival, which was significantly longer in the axi-cel arm with an HR of 0.40 (95% confidence interval, 0.31-0.51; P value < 0.0001) and estimated median of 8.3 months, versus 2.0 months with standard therapy. Among 168 recipients of axi-cel, cytokine release syndrome occurred in 92% (Grade ≥ 3, 7%), neurologic toxicity in 74% (Grade ≥ 3, 25%), prolonged cytopenias in 33%, and fatal adverse reactions in 1.8%. This is the first FDA approval of a CAR T-cell therapy for LBCL in the second-line setting and reflects a potential paradigm shift.
MeSH term(s)	Adult ; Humans ; Antigens, CD19 ; Biological Products/adverse effects ; Biological Products/therapeutic use ; Immunotherapy, Adoptive/methods ; Lymphoma, Large B-Cell, Diffuse/drug therapy ; Lymphoma, Large B-Cell, Diffuse/pathology ; Neoplasm Recurrence, Local/drug therapy ; Drug Approval
Chemical Substances	Antigens, CD19 ; axicabtagene ciloleucel (U2I8T43Y7R) ; Biological Products
Language	English
Publishing date	2023-07-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-23-0568
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Article ; Online: FDA Approval Summary: Lisocabtagene Maraleucel for Second-Line Treatment of Large B-Cell Lymphoma.

Elmacken, Mona / Peredo-Pinto, Helkha / Wang, Cong / Xu, Zhenzhen / Tegenge, Million / Jaigirdar, Adnan A / Theoret, Marc R / Purohit-Sheth, Tejashri / Kasamon, Yvette L

Clinical cancer research : an official journal of the American Association for Cancer Research

2024

Abstract: In June 2022, the FDA extended the indication for lisocabtagene maraleucel (liso-cel) to include adults with large B-lymphoma (LBCL) who have refractory disease or relapse within 12 months of first-line chemoimmunotherapy, as well as transplant- ... ...

Abstract	In June 2022, the FDA extended the indication for lisocabtagene maraleucel (liso-cel) to include adults with large B-lymphoma (LBCL) who have refractory disease or relapse within 12 months of first-line chemoimmunotherapy, as well as transplant-ineligible adults with refractory disease or relapse after first-line chemoimmunotherapy. Two clinical trials evaluating a single infusion of liso-cel preceded by lymphodepleting chemotherapy supported the second-line indications. TRANSFORM is a randomized, phase 3, open-label trial comparing liso-cel to standard second-line therapy, including planned autologous hematopoietic stem cell transplantation (HSCT), in 184 transplant-eligible patients. On interim analysis, event-free survival (EFS) by independent review committee (IRC) assessment was statistically significantly improved for the liso-cel arm, with a stratified hazard ratio of 0.34 (95% CI: 0.22, 0.51; p-value <0.0001); the estimated median EFS was 10.1 months in the liso-cel arm versus 2.3 months in the control arm. PILOT is a single-arm phase 2 trial of second-line liso-cel in patients who were transplant-ineligible due to age or comorbidities but had adequate organ function for CAR-T cell therapy. Among 61 patients who received liso-cel (median age, 74 years), the IRC-assessed complete response rate was 54% (95% CI: 41, 67). Among patients achieving complete response, the estimated 1-year rate of continued response was 68% (95% CI: 45, 83). Of the 268 patients combined who received liso-cel as second-line therapy for LBCL, cytokine release syndrome occurred in 45% (Grade 3, 1.3%) and CAR-T cell associated neurologic toxicities occurred in 27% (Grade 3, 7%), warranting a continued risk evaluation and mitigation strategy.
Language	English
Publishing date	2024-02-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-23-2967
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Article ; Online: Prognostication and Risk-Adapted Therapy of Hodgkin's Lymphoma Using Positron Emission Tomography.

Kasamon, Yvette L

Advances in hematology

2010 Volume 2011, Page(s) 271595

Abstract: The use of (18)F-fluorodeoxyglucose positron emission tomography (FDG-PET) for response assessment in lymphoma is now widespread. Prognostic information obtained from PET performed after two to three cycles of chemotherapy may guide more individualized, ... ...

Abstract	The use of (18)F-fluorodeoxyglucose positron emission tomography (FDG-PET) for response assessment in lymphoma is now widespread. Prognostic information obtained from PET performed after two to three cycles of chemotherapy may guide more individualized, risk-adapted therapeutic strategies. Progress in the risk stratification of Hodgkin's lymphoma through midtreatment PET is reviewed, with a focus on management implications in newly diagnosed and relapsed disease. How to tailor treatment on the basis of the interim PET result is not yet defined but is the subject of ongoing trials.
Language	English
Publishing date	2010-12-22
Publishing country	United States
Document type	Journal Article
ZDB-ID	2494501-8
ISSN	1687-9112 ; 1687-9104
ISSN (online)	1687-9112
ISSN	1687-9104
DOI	10.1155/2011/271595
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Article ; Online: Minimal Residual Disease Data in Hematologic Malignancy Drug Applications and Labeling: An FDA Perspective.

Baines, Andrea C / Yazdy, Maryam Sarraf / Kasamon, Yvette L / Ershler, Rachel / Jen, Emily Y / Kanapuru, Bindu / Richardson, Nicholas C / Lane, Ashley / Carioti, Theresa / Theoret, Marc R / Pazdur, Richard / Gormley, Nicole J

Clinical cancer research : an official journal of the American Association for Cancer Research

2023 Volume 29, Issue 15, Page(s) 2748–2752

Abstract: Minimal residual disease (MRD) is increasingly used as a prognostic biomarker, a measure of clinical efficacy, and a guide for treatment decisions in various hematologic malignancies. We sought to characterize MRD data in registrational trials in ... ...

Abstract	Minimal residual disease (MRD) is increasingly used as a prognostic biomarker, a measure of clinical efficacy, and a guide for treatment decisions in various hematologic malignancies. We sought to characterize MRD data in registrational trials in hematologic malignancies submitted to the U.S. Food and Drug Administration (FDA) with the ultimate goal of expanding the utility of MRD data in future drug applications. We descriptively analyzed MRD data collected in registrational trials, including the type of MRD endpoint, assay, disease compartment(s) assessed, and the acceptance of MRD data in the U.S. prescribing information (USPI). Of 196 drug applications submitted between January 2014 and February 2021, 55 (28%) included MRD data. Of the 55 applications, MRD data was proposed by the Applicant for inclusion in the USPI in 41 (75%) applications but was included in only 24 (59%). Despite an increasing number of applications that proposed to include MRD data in the USPI, the acceptance rate decreased over time. Although MRD data have the potential to expedite drug development, our analysis identified challenges and specific areas for improvement, including assay validation, standardization of collection methods to optimize performance, and considerations in trial design and statistical methodology.
MeSH term(s)	Humans ; United States ; Pharmaceutical Preparations ; Neoplasm, Residual/drug therapy ; Neoplasm, Residual/pathology ; United States Food and Drug Administration ; Hematologic Neoplasms/drug therapy
Chemical Substances	Pharmaceutical Preparations
Language	English
Publishing date	2023-03-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-22-3579
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Article ; Online: FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma.

Telaraja, Deepti / Kasamon, Yvette L / Collazo, Justin S / Leong, Ruby / Wang, Kun / Li, Ping / Dahmane, Elyes / Yang, Yuching / Earp, Justin / Grimstein, Manuela / Rodriguez, Lisa R / Theoret, Marc R / Gormley, Nicole J

Clinical cancer research : an official journal of the American Association for Cancer Research

2023 Volume 30, Issue 1, Page(s) 17–22

Abstract: In January 2023, the FDA granted accelerated approval to pirtobrutinib for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton tyrosine kinase (BTK) ... ...

Abstract	In January 2023, the FDA granted accelerated approval to pirtobrutinib for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. Approval was based on BRUIN, a single-arm study of pirtobrutinib monotherapy in patients with B-cell malignancies. Efficacy was based on independent review committee-assessed overall response rate (ORR) supported by durability of response in 120 patients with relapsed or refractory MCL who had received a prior BTK inhibitor and received the approved pirtobrutinib dosage of 200 mg once daily. The ORR was 50% [95% confidence interval (CI), 41-59], and the complete response rate was 13% (95% CI, 7-20), with an estimated median duration of response of 8.3 months. The most common nonhematologic adverse reactions were fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, and bruising. Warnings and Precautions in labeling include infection, hemorrhage, cytopenias, atrial arrhythmias, and second primary malignancies. Postmarketing studies were required to evaluate longer-term safety of pirtobrutinib and to verify the clinical benefit of pirtobrutinib. This article summarizes key aspects of the regulatory review, including the indication statement, efficacy and safety considerations, and postmarketing requirements.
MeSH term(s)	Adult ; Humans ; Lymphoma, Mantle-Cell/drug therapy ; Lymphoma, Mantle-Cell/pathology ; Pyrazoles/therapeutic use ; Protein Kinase Inhibitors/adverse effects ; Fatigue/chemically induced
Chemical Substances	pirtobrutinib (JNA39I7ZVB) ; Pyrazoles ; Protein Kinase Inhibitors
Language	English
Publishing date	2023-08-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-23-1272
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Article ; Online: Blastic transformation of mantle cell lymphoma.

Kasamon, Yvette L / Burns, Kathleen H

Blood

2012 Volume 120, Issue 12, Page(s) 2359

MeSH term(s)	Humans ; Lymphocyte Activation ; Lymphoma, Mantle-Cell/diagnosis ; Male ; Middle Aged ; Neoplasm Staging
Language	English
Publishing date	2012-10-22
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	80069-7
ISSN	1528-0020 ; 0006-4971
ISSN (online)	1528-0020
ISSN	0006-4971
DOI	10.1182/blood-2011-12-396408
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Uh III Zs.140: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
Zs.MO 364: Show issues

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Article ; Online: Prognostication and Risk-Adapted Therapy of Hodgkin's Lymphoma Using Positron Emission Tomography

Yvette L. Kasamon

Advances in Hematology , Vol

2011 Volume 2011

Keywords	Diseases of the blood and blood-forming organs ; RC633-647.5 ; Specialties of internal medicine ; RC581-951 ; Internal medicine ; RC31-1245 ; Medicine ; R ; DOAJ:Internal medicine ; DOAJ:Medicine (General) ; DOAJ:Health Sciences
Language	English
Publishing date	2011-01-01T00:00:00Z
Publisher	Hindawi Publishing Corporation
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Blood or marrow transplantation for mantle cell lymphoma.

Kasamon, Yvette L

Current opinion in oncology

2007 Volume 19, Issue 2, Page(s) 128–135

Abstract: Purpose of review: Mantle cell lymphoma is a generally incurable disease for which blood or marrow transplantation is frequently considered. This review assesses the more recent literature on high-dose therapeutic approaches for mantle cell lymphoma.: ...

Abstract	Purpose of review: Mantle cell lymphoma is a generally incurable disease for which blood or marrow transplantation is frequently considered. This review assesses the more recent literature on high-dose therapeutic approaches for mantle cell lymphoma. Recent findings: The benefit of transplantation is most apparent in first remission. Autologous transplantation can prolong event-free and possibly overall survival, although no plateau has been demonstrated in the survival curve. A randomized controlled trial demonstrated a significant event-free survival advantage to upfront autologous transplantation compared with interferon maintenance. The relative merit of autologous versus allogeneic transplantation remains to be better defined. Summary: The role of transplantation for mantle cell lymphoma is controversial, as the impact on overall survival is unclear. Transplantation should be considered early in the disease course. Elimination of minimal residual disease through in-vivo purging of stem cells may translate into more durable remissions. Nonmyeloablative allogeneic transplantation and high-dose radioimmunotherapy are topics of ongoing investigation.
MeSH term(s)	Bone Marrow Transplantation ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Lymphoma, Mantle-Cell/therapy ; Radioimmunotherapy ; Radiotherapy Dosage ; Randomized Controlled Trials as Topic ; Transplantation Conditioning/methods ; Transplantation, Autologous
Language	English
Publishing date	2007-03
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1049384-0
ISSN	1531-703X ; 1040-8746
ISSN (online)	1531-703X
ISSN	1040-8746
DOI	10.1097/CCO.0b013e3280148a43
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Zs.A 3046: Show issues

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Article ; Online: FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma.

Bouchkouj, Najat / Zimmerman, Megan / Kasamon, Yvette L / Wang, Cong / Dai, Tianjiao / Xu, Zhenzhen / Wang, Xiaofei / Theoret, Marc / Purohit-Sheth, Tejashri / George, Bindu

The oncologist

2022 Volume 27, Issue 7, Page(s) 587–594

Abstract: In March 2021, the U.S. Food and Drug Administration granted accelerated approval to axicabtagene ciloleucel, a CD19-directed chimeric antigen receptor T-cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/ ...

Abstract	In March 2021, the U.S. Food and Drug Administration granted accelerated approval to axicabtagene ciloleucel, a CD19-directed chimeric antigen receptor T-cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after at least 2 lines of systemic therapy. Approval was based on ZUMA-5, a single-arm, open-label, multicenter trial that evaluated a single infusion of axicabtagene ciloleucel, preceded by lymphodepleting chemotherapy with cyclophosphamide and fludarabine, in this population. Efficacy was based on objective response rate (ORR) and duration of response (DOR) as determined by an independent review committee. Among 81 patients in the primary efficacy analysis, having a median of 3 (range 2-9) prior lines of systemic therapy, the ORR was 91% (95% confidence interval [CI]: 83-96) with a complete remission (CR) rate of 60% and a median time-to-response of 1 month. The median DOR was not reached, and the 1-year rate of continued remission was 76% (95% CI: 64-85). For all leukapheresed patients with FL in this trial (n = 123), the ORR was 89% (95% CI: 83-94) with a CR rate of 62%. Among 146 patients with indolent lymphoma evaluated for safety, cytokine release syndrome occurred in 84% (Grade ≥3, 8%) and neurological toxicities occurred in 77% (Grade ≥3, 21%), leading to implementation of a risk evaluation and mitigation strategy. Serious adverse reactions occurred in 48%. Post-marketing studies will further evaluate clinical benefit in patients with r/r FL and long-term safety.
MeSH term(s)	Adult ; Antigens, CD19/therapeutic use ; Biological Products/pharmacology ; Biological Products/therapeutic use ; Humans ; Immunotherapy, Adoptive/adverse effects ; Lymphoma, Follicular/drug therapy ; Lymphoma, Large B-Cell, Diffuse/pathology
Chemical Substances	Antigens, CD19 ; Biological Products ; axicabtagene ciloleucel (U2I8T43Y7R)
Language	English
Publishing date	2022-04-19
Publishing country	England
Document type	Journal Article ; Multicenter Study
ZDB-ID	1409038-7
ISSN	1549-490X ; 1083-7159
ISSN (online)	1549-490X
ISSN	1083-7159
DOI	10.1093/oncolo/oyac054
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Zs.A 4845: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 494: Show issues

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Article ; Online: Tailored strategies for radiation therapy in classical Hodgkin's lymphoma.

Terezakis, Stephanie A / Kasamon, Yvette L

Critical reviews in oncology/hematology

2012 Volume 84, Issue 1, Page(s) 71–84

Abstract: Radiotherapeutic advances have contributed to the evolution of Hodgkin's lymphoma (HL) treatment paradigms. A reduction in radiation therapy (RT) field size and dose has the potential to significantly impact the therapeutic ratio by diminishing late ... ...

Abstract	Radiotherapeutic advances have contributed to the evolution of Hodgkin's lymphoma (HL) treatment paradigms. A reduction in radiation therapy (RT) field size and dose has the potential to significantly impact the therapeutic ratio by diminishing late toxicities while maintaining curability. Substantial progress in risk stratification has contributed to the development of tailored RT strategies which address both field design as well as dose. Technologic improvements have also enhanced the ability to adapt the RT technique to the individual patient. The refinement of the RT approach and its incorporation into current combined modality strategies in adult classical HL is the subject of ongoing investigation and is critically reviewed.
MeSH term(s)	Combined Modality Therapy ; Hodgkin Disease/radiotherapy ; Humans ; Radiation Dosage
Language	English
Publishing date	2012-03-29
Publishing country	Netherlands
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Review
ZDB-ID	605680-5
ISSN	1879-0461 ; 0737-9587 ; 1040-8428
ISSN (online)	1879-0461
ISSN	0737-9587 ; 1040-8428
DOI	10.1016/j.critrevonc.2012.02.006
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