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Article: FDA Drug Approval: Elotuzumab in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma.

Gormley, Nicole J / Ko, Chia-Wen / Deisseroth, Albert / Nie, Lei / Kaminskas, Edvardas / Kormanik, Natasha / Goldberg, Kirsten B / Farrell, Ann T / Pazdur, Richard

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

2017 Volume 23, Issue 22, Page(s) 6759–6763

Abstract: On November 30, 2015, the FDA approved elotuzumab (Empliciti; Bristol-Myers Squibb) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who received one to three prior therapies. FDA approval was based ... ...

Abstract	On November 30, 2015, the FDA approved elotuzumab (Empliciti; Bristol-Myers Squibb) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who received one to three prior therapies. FDA approval was based primarily on the results of a phase III, randomized, open-label, multicenter trial, CA204004, which evaluated elotuzumab in combination with lenalidomide and dexamethasone (E-Ld) compared with lenalidomide and dexamethasone (Ld) alone in patients with relapsed or refractory multiple myeloma. Coprimary endpoints were progression-free survival (PFS) and overall response rate (ORR). The key secondary endpoint was overall survival, but these data were not mature at the time of clinical database cutoff. The trial demonstrated a statistically significant improvement in PFS, with an estimated HR of 0.70 for E-Ld over Ld [95% confidence interval (CI), 0.57-0.85;
MeSH term(s)	Antibodies, Monoclonal, Humanized/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Clinical Trials, Phase III as Topic ; Dexamethasone ; Drug Approval ; Drug Resistance, Neoplasm ; Humans ; Multicenter Studies as Topic ; Multiple Myeloma/drug therapy ; Multiple Myeloma/mortality ; Multiple Myeloma/pathology ; Randomized Controlled Trials as Topic ; Recurrence ; Thalidomide/analogs & derivatives ; Treatment Outcome
Chemical Substances	Antibodies, Monoclonal, Humanized ; elotuzumab (1351PE5UGS) ; Thalidomide (4Z8R6ORS6L) ; Dexamethasone (7S5I7G3JQL) ; lenalidomide (F0P408N6V4)
Language	English
Publishing date	2017-11-15
Publishing country	United States
Document type	News
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-16-2870
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Article ; Online: Gemtuzumab ozogamicin.

Przepiorka, Donna / Deisseroth, Albert / Kane, Robert / Kaminskas, Edvardas / Farrell, Ann T / Pazdur, Richard

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

2013 Volume 31, Issue 13, Page(s) 1699–1700

MeSH term(s)	Aminoglycosides/therapeutic use ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Female ; Humans ; Leukemia, Myeloid, Acute/drug therapy ; Leukemia, Myeloid, Acute/mortality ; Male ; Myelodysplastic Syndromes/drug therapy ; Myelodysplastic Syndromes/mortality
Chemical Substances	Aminoglycosides ; Antibodies, Monoclonal, Humanized
Language	English
Publishing date	2013-05-01
Publishing country	United States
Document type	Comment ; Letter
ZDB-ID	604914-x
ISSN	1527-7755 ; 0732-183X
ISSN (online)	1527-7755
ISSN	0732-183X
DOI	10.1200/JCO.2012.48.1887
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Zs.A 1847: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim-Chester Disease with the

Oneal, Patricia A / Kwitkowski, Virginia / Luo, Lola / Shen, Yuan Li / Subramaniam, Sriram / Shord, Stacy / Goldberg, Kirsten B / McKee, Amy E / Kaminskas, Edvardas / Farrell, Ann / Pazdur, Richard

The oncologist

2018 Volume 23, Issue 12, Page(s) 1520–1524

Abstract: On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to vemurafenib for the treatment of adult patients with Erdheim-Chester disease (ECD) ... ...

Abstract	On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to vemurafenib for the treatment of adult patients with Erdheim-Chester disease (ECD) with
MeSH term(s)	Adult ; Aged ; Antineoplastic Agents/pharmacology ; Antineoplastic Agents/therapeutic use ; Erdheim-Chester Disease/drug therapy ; Erdheim-Chester Disease/pathology ; Female ; Humans ; Male ; Middle Aged ; Mutation ; Proto-Oncogene Proteins B-raf/genetics ; United States ; United States Food and Drug Administration ; Vemurafenib/pharmacology ; Vemurafenib/therapeutic use
Chemical Substances	Antineoplastic Agents ; Vemurafenib (207SMY3FQT) ; Proto-Oncogene Proteins B-raf (EC 2.7.11.1)
Language	English
Publishing date	2018-08-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	1409038-7
ISSN	1549-490X ; 1083-7159
ISSN (online)	1549-490X
ISSN	1083-7159
DOI	10.1634/theoncologist.2018-0295
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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)
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Article ; Online: NOAC monitoring, reversal agents, and post-approval safety and effectiveness evaluation: A cardiac safety research consortium think tank.

Reiffel, James A / Weitz, Jeffrey I / Reilly, Paul / Kaminskas, Edvardas / Sarich, Troy / Sager, Philip / Seltzer, Jonathan

American heart journal

2016 Volume 177, Page(s) 74–86

Abstract: Four non-vitamin K antagonist oral anticoagulants (dabigatran, rivaroxaban, apixaban, and edoxaban) have been approved in the United States for treatment of atrial fibrillation (AF) and venous thromboembolic disease. They have been as or more effective ... ...

Abstract	Four non-vitamin K antagonist oral anticoagulants (dabigatran, rivaroxaban, apixaban, and edoxaban) have been approved in the United States for treatment of atrial fibrillation (AF) and venous thromboembolic disease. They have been as or more effective than the prior standards of care, with less fatal or intracranial bleeding, fewer drug and dietary interactions, and greater patient convenience. Nonetheless, the absence of the ability for clinicians to assess compliance or washout with a simple laboratory test (or to adjust dosing with a similar assessment) and the absence of an antidote to rapidly stop major hemorrhage or to enhance safety in the setting of emergent or urgent surgery/procedures have been limitations to greater non-vitamin K antagonist oral anticoagulant usage and better thromboembolic prevention. Accordingly, a Cardiac Research Safety Consortium "think tank" meeting was held in February 2015 to address these concerns. This manuscript reports on the discussions held and the conclusions reached at that meeting.
MeSH term(s)	Antibodies, Monoclonal, Humanized ; Antidotes/therapeutic use ; Antithrombins/therapeutic use ; Arginine/analogs & derivatives ; Atrial Fibrillation/complications ; Atrial Fibrillation/drug therapy ; Congresses as Topic ; Dabigatran/therapeutic use ; Drug Monitoring ; Factor Xa ; Factor Xa Inhibitors/therapeutic use ; Humans ; Partial Thromboplastin Time ; Piperazines ; Product Surveillance, Postmarketing ; Pyrazoles/therapeutic use ; Pyridines/therapeutic use ; Pyridones/therapeutic use ; Recombinant Proteins ; Rivaroxaban/therapeutic use ; Stroke/etiology ; Stroke/prevention & control ; Thiazoles/therapeutic use ; Thrombin Time ; Venous Thromboembolism/drug therapy ; Venous Thromboembolism/prevention & control
Chemical Substances	Antibodies, Monoclonal, Humanized ; Antidotes ; Antithrombins ; Factor Xa Inhibitors ; PRT064445 ; Piperazines ; Pyrazoles ; Pyridines ; Pyridones ; Recombinant Proteins ; Thiazoles ; apixaban (3Z9Y7UWC1J) ; Arginine (94ZLA3W45F) ; idarucizumab (97RWB5S1U6) ; Rivaroxaban (9NDF7JZ4M3) ; Factor Xa (EC 3.4.21.6) ; Dabigatran (I0VM4M70GC) ; edoxaban (NDU3J18APO) ; PER977 (U2R67KV65Q)
Language	English
Publishing date	2016-04-23
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	80026-0
ISSN	1097-6744 ; 0002-8703
ISSN (online)	1097-6744
ISSN	0002-8703
DOI	10.1016/j.ahj.2016.04.010
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Article ; Online: Novel oral anticoagulants and reversal agents: Considerations for clinical development.

Sarich, Troy C / Seltzer, Jonathan H / Berkowitz, Scott D / Costin', James / Curnutte, John T / Gibson, C Michael / Hoffman, Maureane / Kaminskas, Edvardas / Krucoff, Mitchell W / Levy, Jerrold H / Mintz, Paul D / Reilly, Paul A / Sager, Philip T / Singer, Daniel E / Stockbridge, Norman / Weitz, Jeffrey I / Kowey, Peter R

American heart journal

2015 Volume 169, Issue 6, Page(s) 751–757

Abstract: This white paper provides a summary of presentations and discussions that were held at an Anticoagulant-Induced Bleeding and Reversal Agents Think Tank co-sponsored by the Cardiac Safety Research Consortium and the US Food and Drug Administration (FDA) ... ...

Abstract	This white paper provides a summary of presentations and discussions that were held at an Anticoagulant-Induced Bleeding and Reversal Agents Think Tank co-sponsored by the Cardiac Safety Research Consortium and the US Food and Drug Administration (FDA) at the FDA's White Oak Headquarters on April 22, 2014. Attention focused on a development pathway for reversal agents for the novel oral anticoagulants (NOACs). This is important because anticoagulation is still widely underused for stroke prevention in patients with atrial fibrillation. Undertreatment persists, although NOACs, in general, overcome some of the difficulties associated with anticoagulation provided by vitamin K antagonists. One reason for the lack of a wider uptake is the absence of NOAC reversal agents. As there are neither widely accepted academic and industry standards nor a definitive regulatory policy on the development of such reversal agents, this meeting provided a forum for leaders in the fields of cardiovascular clinical trials and cardiovascular safety to discuss the issues and develop recommendations. Attendees included representatives from pharmaceutical companies; regulatory agencies; end point adjudication specialist groups; contract research organizations; and active, academically based physicians. There was wide and solid consensus that NOACs overall offer improvements in convenience, efficacy, and safety compared with warfarin, even without reversal agents. Still, it was broadly accepted that it would be helpful to have reversal agents available for clinicians to use. Because it is not feasible to do definitive outcomes studies demonstrating a reversal agent's clinical benefits, it was felt that these agents could be approved for use in life-threatening bleeding situations if the molecules were well characterized preclinically, their pharmacodynamic and pharmacokinetic profiles were well understood, and showed no harmful adverse events in early human testing. There was also consensus that after such approval, efforts should be made to augment the available clinical information until such time as there is a body of evidence to demonstrate real-world clinical outcomes with the reversal agents. No recommendations were made for more generalized use of these agents in the setting of non-life-threatening situations. This article reflects the views of the authors and should not be construed to represent FDA's views or policies.
MeSH term(s)	Administration, Oral ; Antibodies, Monoclonal, Humanized/therapeutic use ; Anticoagulants/adverse effects ; Anticoagulants/therapeutic use ; Arginine/analogs & derivatives ; Arginine/therapeutic use ; Cardiovascular Diseases/drug therapy ; Factor Xa/therapeutic use ; Factor Xa Inhibitors/therapeutic use ; Hemorrhage/chemically induced ; Hemorrhage/prevention & control ; Humans ; Piperazines/therapeutic use ; Recombinant Proteins/therapeutic use ; Stroke/prevention & control
Chemical Substances	Antibodies, Monoclonal, Humanized ; Anticoagulants ; Factor Xa Inhibitors ; Piperazines ; Recombinant Proteins ; Arginine (94ZLA3W45F) ; idarucizumab (97RWB5S1U6) ; Factor Xa (EC 3.4.21.6) ; PER977 (U2R67KV65Q)
Language	English
Publishing date	2015-03-26
Publishing country	United States
Document type	Consensus Development Conference ; Journal Article
ZDB-ID	80026-0
ISSN	1097-6744 ; 0002-8703
ISSN (online)	1097-6744
ISSN	0002-8703
DOI	10.1016/j.ahj.2015.03.010
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Article: FDA drug approval summary: azacitidine (5-azacytidine, Vidaza) for injectable suspension.

Kaminskas, Edvardas / Farrell, Ann T / Wang, Yong-Cheng / Sridhara, Rajeshwari / Pazdur, Richard

The oncologist

2005 Volume 10, Issue 3, Page(s) 176–182

Abstract: On May 19, 2004, azacitidine (5-azacytidine; Vidaza(trade mark); Pharmion Corporation, Boulder, CO, http://www.pharmion.com) for injectable suspension received regular approval by the U.S. Food and Drug Administration (FDA) for the treatment of all ... ...

Abstract	On May 19, 2004, azacitidine (5-azacytidine; Vidaza(trade mark); Pharmion Corporation, Boulder, CO, http://www.pharmion.com) for injectable suspension received regular approval by the U.S. Food and Drug Administration (FDA) for the treatment of all subtypes of myelodysplastic syndrome (MDS). This report summarizes the basis for this approval. Effectiveness was demonstrated in one randomized, controlled trial comparing azacitidine administered s.c. with best supportive care (observation group) and in two single-arm studies, one in which azacitidine was administered s.c. and in the other in which it was administered i.v. The dose of azacitidine, 75 mg/m2/day for 7 days every 28 days, was the same in all three studies. In the randomized trial, study participants were well matched with respect to age, sex, race, performance status, MDS subtype, and use of transfusion during the 3 months before study entry. Patients in the observation arm were permitted by protocol to cross over to azacitidine treatment if their disease progressed according to prespecified criteria. During the course of the study, more than half of the patients in the observation arm did cross over to the azacitidine treatment arm. The primary efficacy end point was the overall response rate. Response consisted of complete or partial normalization of blood cell counts and of bone marrow morphology. The response rate in the azacitidine arm was about 16%; there were no responses in the observation arm. The response rates in the two single-arm studies were similar (13% and 19%). The responses were sustained, with median durations of 11 months and 17 months respectively. Responding patients who were transfusion dependent at study entry lost the need for transfusions. In addition, about 19% of patients had less than partial responses (termed improvement), and two-thirds of them became transfusion independent. Common adverse events associated with azacitidine treatment were gastrointestinal (nausea, vomiting, diarrhea, constipation, and anorexia), hematologic (neutropenia, thrombocytopenia), fevers, rigors, ecchymoses, petechiae, injection site events, arthralgia, headache, and dizziness. Liver function abnormalities occurred in 16% of patients with intercurrent hepatobiliary disorders and in two patients with previously diagnosed liver cirrhosis. Renal failure occurred in patients during sepsis and hypotension. There were no deaths attributed to azacitidine. Azacitidine, the first drug approved by the U.S. FDA for MDS, has a favorable safety profile and provides a clinical benefit of eliminating transfusion dependence and complete or partial normalization of blood counts and bone marrow blast percentages in responding patients.
MeSH term(s)	Adolescent ; Adult ; Aged ; Antimetabolites, Antineoplastic/administration & dosage ; Antimetabolites, Antineoplastic/adverse effects ; Antimetabolites, Antineoplastic/therapeutic use ; Azacitidine/administration & dosage ; Azacitidine/adverse effects ; Azacitidine/therapeutic use ; Blood Transfusion ; Drug Approval ; Female ; Humans ; Infusions, Intravenous ; Injections, Subcutaneous ; Male ; Middle Aged ; Myelodysplastic Syndromes/drug therapy ; Randomized Controlled Trials as Topic ; Treatment Outcome ; United States ; United States Food and Drug Administration
Chemical Substances	Antimetabolites, Antineoplastic ; Azacitidine (M801H13NRU)
Language	English
Publishing date	2005-03
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1409038-7
ISSN	1083-7159
ISSN	1083-7159
DOI	10.1634/theoncologist.10-3-176
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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)
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Article: FDA approval: idelalisib monotherapy for the treatment of patients with follicular lymphoma and small lymphocytic lymphoma.

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

2015 Volume 21, Issue 7, Page(s) 1525–1529

Abstract: On July 23, 2014, the FDA granted accelerated approval to idelalisib (Zydelig tablets; Gilead Sciences, Inc.) for the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma or relapsed small lymphocytic lymphoma (SLL) who have ... ...

Abstract	On July 23, 2014, the FDA granted accelerated approval to idelalisib (Zydelig tablets; Gilead Sciences, Inc.) for the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma or relapsed small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies. In a multicenter, single-arm trial, 123 patients with relapsed indolent non-Hodgkin lymphomas received idelalisib, 150 mg orally twice daily. In patients with follicular lymphoma, the overall response rate (ORR) was 54%, and the median duration of response (DOR) was not evaluable; median follow-up was 8.1 months. In patients with SLL, the ORR was 58% and the median DOR was 11.9 months. One-half of patients experienced a serious adverse reaction of pneumonia, pyrexia, sepsis, febrile neutropenia, diarrhea, or pneumonitis. Other common adverse reactions were abdominal pain, nausea, fatigue, cough, dyspnea, and rash. Common treatment-emergent laboratory abnormalities were elevations in alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, absolute lymphocytes, and triglycerides. Continued approval may be contingent upon verification of clinical benefit in confirmatory trials.
MeSH term(s)	Antineoplastic Agents/therapeutic use ; Class I Phosphatidylinositol 3-Kinases/antagonists & inhibitors ; Humans ; Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy ; Lymphoma, Follicular/drug therapy ; Purines/therapeutic use ; Quinazolinones/therapeutic use
Chemical Substances	Antineoplastic Agents ; Purines ; Quinazolinones ; Class I Phosphatidylinositol 3-Kinases (EC 2.7.1.137)
Language	English
Publishing date	2015-04-01
Publishing country	United States
Document type	Comment ; Journal Article
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-14-2522
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Article: FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma.

Lee, Hyon-Zu / Kwitkowski, Virginia E / Del Valle, Pedro L / Ricci, M Stacey / Saber, Haleh / Habtemariam, Bahru A / Bullock, Julie / Bloomquist, Erik / Li Shen, Yuan / Chen, Xiao-Hong / Brown, Janice / Mehrotra, Nitin / Dorff, Sarah / Charlab, Rosane / Kane, Robert C / Kaminskas, Edvardas / Justice, Robert / Farrell, Ann T / Pazdur, Richard

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

2015 Volume 21, Issue 12, Page(s) 2666–2670

Abstract: On July 3, 2014, the FDA granted accelerated approval for belinostat (Beleodaq; Spectrum Pharmaceuticals, Inc.), a histone deacetylase inhibitor, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). A single-arm, ... ...

Abstract	On July 3, 2014, the FDA granted accelerated approval for belinostat (Beleodaq; Spectrum Pharmaceuticals, Inc.), a histone deacetylase inhibitor, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). A single-arm, open-label, multicenter, international trial in the indicated patient population was submitted in support of the application. Belinostat was administered intravenously at a dose of 1000 mg/m(2) over 30 minutes once daily on days 1 to 5 of a 21-day cycle. The primary efficacy endpoint was overall response rate (ORR) based on central radiology readings by an independent review committee. The ORR was 25.8% [95% confidence interval (CI), 18.3-34.6] in 120 patients that had confirmed diagnoses of PTCL by the Central Pathology Review Group. The complete and partial response rates were 10.8% (95% CI, 5.9-17.8) and 15.0% (95% CI, 9.1-22.7), respectively. The median duration of response, the key secondary efficacy endpoint, was 8.4 months (95% CI, 4.5-29.4). The most common adverse reactions (>25%) were nausea, fatigue, pyrexia, anemia, and vomiting. Grade 3/4 toxicities (≥5.0%) included anemia, thrombocytopenia, dyspnea, neutropenia, fatigue, and pneumonia. Belinostat is the third drug to receive accelerated approval for the treatment of relapsed or refractory PTCL.
MeSH term(s)	Antineoplastic Agents/therapeutic use ; Drug Approval ; Histone Deacetylase Inhibitors/therapeutic use ; Humans ; Hydroxamic Acids/therapeutic use ; Lymphoma, T-Cell, Peripheral/drug therapy ; Lymphoma, T-Cell, Peripheral/pathology ; Sulfonamides/therapeutic use ; United States ; United States Food and Drug Administration
Chemical Substances	Antineoplastic Agents ; Histone Deacetylase Inhibitors ; Hydroxamic Acids ; Sulfonamides ; belinostat (F4H96P17NZ)
Language	English
Publishing date	2015-06-15
Publishing country	United States
Document type	Letter
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-14-3119
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Article ; Online: FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia.

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

2015 Volume 21, Issue 16, Page(s) 3586–3590

Abstract: On November 13, 2013, the FDA granted accelerated approval to ibrutinib (IMBRUVICA capsules; Pharmacyclics, Inc.) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. On February 12, 2014, the FDA ... ...

Abstract	On November 13, 2013, the FDA granted accelerated approval to ibrutinib (IMBRUVICA capsules; Pharmacyclics, Inc.) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. On February 12, 2014, the FDA granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor that received all four expedited programs of the FDA: Fast-Track designation, Breakthrough Therapy designation, Priority Review, and Accelerated Approval. Both approvals were based on overall response rate (ORR) and duration of response (DOR) in single-arm clinical trials in patients with prior treatment. In MCL (N = 111), the complete and partial response rates were 17.1% and 48.6%, respectively, for an ORR of 65.8% [95% confidence interval (CI), 56.2%-74.5%]. The median DOR was 17.5 months (95% CI, 15.8-not reached). In CLL (N = 48), the ORR was 58.3% (95% CI, 43.2%-72.4%), and the DOR ranged from 5.6 to 24.2 months. The most common adverse reactions (≥ 30% in either trial) were thrombocytopenia, diarrhea, neutropenia, bruising, upper respiratory tract infection, anemia, fatigue, musculoskeletal pain, peripheral edema, and nausea.
MeSH term(s)	Aged ; Clinical Trials as Topic ; Drug Approval/legislation & jurisprudence ; Female ; Humans ; Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy ; Leukemia, Lymphocytic, Chronic, B-Cell/pathology ; Lymphoma, Mantle-Cell/drug therapy ; Lymphoma, Mantle-Cell/pathology ; Male ; Middle Aged ; Protein Kinase Inhibitors/therapeutic use ; Pyrazoles/adverse effects ; Pyrazoles/pharmacokinetics ; Pyrazoles/therapeutic use ; Pyrimidines/adverse effects ; Pyrimidines/pharmacokinetics ; Pyrimidines/therapeutic use ; United States
Chemical Substances	Protein Kinase Inhibitors ; Pyrazoles ; Pyrimidines ; ibrutinib (1X70OSD4VX)
Language	English
Publishing date	2015-08-07
Publishing country	United States
Document type	Journal Article ; Multicenter Study
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-14-2225
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Article ; Online: U.S. Food and Drug Administration approval summary: omacetaxine mepesuccinate as treatment for chronic myeloid leukemia.

Alvandi, Firoozeh / Kwitkowski, Virginia E / Ko, Chia-Wen / Rothmann, Mark D / Ricci, Stacey / Saber, Haleh / Ghosh, Debasis / Brown, Janice / Pfeiler, Erika / Chikhale, Elsbeth / Grillo, Joseph / Bullock, Julie / Kane, Robert / Kaminskas, Edvardas / Farrell, Ann T / Pazdur, Richard

The oncologist

2013 Volume 19, Issue 1, Page(s) 94–99

Abstract: On October 26, 2012, the U.S. Food and Drug Administration (FDA) granted accelerated approval to omacetaxine mepesuccinate (Synribo; Teva Pharmaceuticals USA, Inc., North Wales, PA, http://www.tevausa.com) for the treatment of adult patients with chronic ...

Abstract	On October 26, 2012, the U.S. Food and Drug Administration (FDA) granted accelerated approval to omacetaxine mepesuccinate (Synribo; Teva Pharmaceuticals USA, Inc., North Wales, PA, http://www.tevausa.com) for the treatment of adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs). The approval was based on the FDA review of data from 111 patients with CML in CP or in AP who had received two or more prior TKIs, including imatinib. Major cytogenetic response was achieved in 18% of patients with CP, with a median response duration of 12.5 months. Major hematologic response was achieved in 14% of patients with AP, with a median response duration of 4.7 months. The FDA safety evaluation was based on submitted data from 163 patients with CP or AP CML who had received at least one dose of omacetaxine mepesuccinate. The safety evaluation was limited by the single-arm design of the clinical trials as conducted in a small number of previously treated patients. The most common (≥20%) adverse reactions of any grade in enrolled patients included thrombocytopenia, anemia, neutropenia, diarrhea, nausea, fatigue, asthenia, injection site reaction, pyrexia, and infection. The FDA concluded that omacetaxine mepesuccinate has shown activity and a favorable benefit-to-risk profile for the studied population of adult patients with CML (CP or AP) with resistance and/or intolerance to two or more TKIs. Further evidence of response durability to verify clinical benefit is pending.
MeSH term(s)	Aged ; Angiogenesis Inhibitors/adverse effects ; Angiogenesis Inhibitors/pharmacology ; Angiogenesis Inhibitors/therapeutic use ; Clinical Trials, Phase II as Topic ; Drug Approval ; Female ; Harringtonines/adverse effects ; Harringtonines/pharmacology ; Harringtonines/therapeutic use ; Homoharringtonine ; Humans ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy ; Male ; Middle Aged ; United States ; United States Food and Drug Administration
Chemical Substances	Angiogenesis Inhibitors ; Harringtonines ; Homoharringtonine (6FG8041S5B)
Language	English
Publishing date	2013-12-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	1409038-7
ISSN	1549-490X ; 1083-7159
ISSN (online)	1549-490X
ISSN	1083-7159
DOI	10.1634/theoncologist.2013-0077
Database	MEDical Literature Analysis and Retrieval System OnLINE

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