Spectrum Pharmaceuticals Highlights 11 Abstracts at the 56th Annual Meeting of the American Society of Hematology (ASH) in San Francisco, California, December 6-9, 2014
For more information about the ASH annual meeting and for a complete list of abstracts, please refer to the conference website at https://ash.confex.com/ash/2014/webprogram/start.html.
The following are key abstracts being presented at the ASH meeting:
|ZEVALIN® (ibritumomab tiuxetan) Injection-related Abstracts|
|1762||Poster||Phase II study of Yttrium-90 Ibritumomab Tiuxetan (Zevalin) in Patients with Previously Untreated Marginal Zone Lymphoma||Fabregas||
|1746||Poster||Consolidative Radioimmunotherapy after Chemoimmunotherapy in Patients with Histologic Transformation of Indolent Lymphoma||Reagan||
|1733||Poster||Short Course of Bendamustine and Rituximab followed by Yttrium-90 Ibritumomab Tiuxetan in Patients with Chemotherapy-Naïve Follicular Lymphoma: Results of Fol-BRITe||Lansigan||
|3986||Poster||Minimum Tolerable Interval of Radioimmunotherapy and Autologous Stem Cell Transplantation after High-Dose Chemotherapy for Relapsed or Refractory Aggressive B Cell Non-Hodgkin-Lymphoma Provides Excellent Disease Control||
Yttrium-90 Ibritumomab Tiuxetan for Non-Hodgkin Lymphoma: Results
after a Median Follow-up of 5 Years in a
|4414||Poster||Long term follow up of SWOG S0313: Ibritumomab Tiuxetan Consolidation after 3 Cycles of CHOP Plus Radiotherapy for High Risk Limited Stage Aggressive B-Cell Lymphoma||Persky||
|Beleodaq® (belinostat) for Injection-related Abstracts|
|Abstract #||Type||Title||First Author||Location|
|3075||Poster||Safe and Effective Treatment of Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL) and Low Baseline Platelet Counts with Belinostat||Savage||
|265||Oral||Big Data Approach to Identify Molecular Basis for Drug Sensitivity Phenotypes in Acute Myeloid Leukemia||Su-In Lee||
|N/A||Publication||Subsequent Hematopoietic Stem Cell Transplantation in Belinostat-treated Patients with Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL)||Shustov||Publication only|
|Abstract #||Type||Title||First Author||Location|
COMPLETE Registry- Patient Characteristics and Treatment Patterns in
|Marqibo® (vinCRIStine sulfate LIPOSOME injection)-related Abstracts|
Liposomal Formulation of Vincristine Allows for Doubling the Dose
Compared to Conventional Vincristine: Results of the First Futility
Analysis of the OPTIMAL > 60 Study of the
About ZEVALIN and the ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan) injection for intravenous use is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). ZEVALIN is also indicated for the treatment of patients with previously untreated follicular non-Hodgkin's Lymphoma who achieve a partial or complete response to first-line chemotherapy.
ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN
therapeutic regimen consists of two components: rituximab, and
Important ZEVALIN Safety Information
Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. ZEVALIN administration can result in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen.
Please see full Prescribing Information, including BOXED WARNINGS, for ZEVALIN and rituximab. Full prescribing information for ZEVALIN can be found at www.ZEVALIN.com.
Beleodaq is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some non-histone proteins. In vitro, belinostat caused the accumulation of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells. Belinostat shows preferential cytotoxicity towards tumor cells compared to normal cells. Belinostat inhibited the enzymatic activity of histone deacetylases at nanomolar concentrations ( < 250 nM).
Please see Beleodaq Full Prescribing Information at www.beleodaq.com.
Indications and Usage
Beleodaq is a histone deacetylase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
Important Beleodaq Safety Information
Warnings and Precautions
- Beleodaq can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and/or anemia; monitor blood counts weekly during treatment, and modify dosage as necessary.
- Serious and sometimes fatal infections, including pneumonia and sepsis, have occurred with Beleodaq. Do not administer Beleodaq to patients with an active infection. Patients with a history of extensive or intensive chemotherapy may be at higher risk of life threatening infections.
- Beleodaq can cause fatal hepatotoxicity and liver function test abnormalities. Monitor liver function tests before treatment and before the start of each cycle. Interrupt or adjust dosage until recovery, or permanently discontinue Beleodaq based on the severity of the hepatic toxicity.
- Tumor lysis syndrome has occurred in Beleodaq-treated patients in the clinical trial of patients with relapsed or refractory PTCL. Monitor patients with advanced stage disease and/or high tumor burden and take appropriate precautions.
- Nausea, vomiting and diarrhea occur with Beleodaq and may require the use of antiemetic and antidiarrheal medications.
- Beleodaq can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid pregnancy while receiving Beleodaq. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of potential hazard to the fetus.
- The most common adverse reactions observed in the trial in patients with relapsed or refractory PTCL treated with Beleodaq were nausea (42%), fatigue (37%), pyrexia (35%), anemia (32%), and vomiting (29%).
- Sixty-one patients (47.3%) experienced serious adverse reactions while taking Beleodaq or within 30 days after their last dose of Beleodaq.
- Beleodaq is primarily metabolized by UGT1A1. Avoid concomitant administration of Beleodaq with strong inhibitors of UGT1A1.
Use in Specific Populations
- It is not known whether Beleodaq is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Beleodaq, a decision should be made whether to discontinue nursing or discontinue drug, taking into account the importance of the drug to the mother.
MARQIBO is a novel, sphingomyelin/cholesterol liposome-encapsulated,
formulation of vincristine sulfate. Vincristine, a microtubule
Please see important safety information below and the full prescribing information for MARQIBO at www.marqibo.com.
Indication and usage
MARQIBO is a liposomal vinca alkaloid indicated for the treatment of
adult patients with
Important safety information
- MARQIBO is contraindicated in patients with demyelinating conditions including Charcot-Marie-Tooth syndrome
- MARQIBO is contraindicated in patients with hypersensitivity to vincristine sulfate or any of the other components of MARQIBO (vinCRIStine sulfate LIPOSOME injection
- MARQIBO is contraindicated for intrathecal administration
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forward-looking statements regarding future events and the future
Vice President, Strategic Planning & Investor Relations
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