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(belantamab mafodotin-blmf)

Blenrep REMS Blenrep Resources for Eye Care Professionals Material Safety Data Sheet Environmental Risk Assessments
How Supplied/Storage & Handling arrow-down arrow-up
  • BLENREP for injection is a sterile, preservative-free, white to yellow, lyophilized powder in single-dose vials for reconstitution and dilution prior to intravenous use.
  • BLENREP is supplied in a carton containing one 100 mg single-dose vial with a rubber stopper (not made with natural rubber latex) and aluminum overseal with removeable cap (NDC 0173-0896-01).
  • Store BLENREP vials under refrigeration at 36ºF to 46ºF (2ºC to 8ºC).
  • BLENREP is a hazardous drug. Follow applicable special handling and disposal procedures,

  • Reconstituted Solution
    • If the reconstituted solution is not used immediately, store refrigerated at 36ºF to 46ºF (2ºC to 8ºC) or at room temperature (68ºF to 77ºF [20ºC to 25ºC], for up to 4 hours in the original container. Discard if not diluted within 4 hours. Do not freeze.
    • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The diluted infusion solution should be clear and colorless. Discard if particulate matter is observed.

  • Diluted Solution
    • If the diluted solution of BLENREP is not used immediately, store refrigerated 36ºF to 46ºF (2ºC to 8ºC) for up to 24 hours. Do not freeze. Once removed from refrigeration, administer the diluted infusion solution of BLENREP within 6 hours (including infusion time).
    • If refrigerated, allow the diluted infusion solution to equilibrate to room temperature (68ºF to 77ºF [20ºC to 25ºC]) prior to administration. Diluted solution may be kept at room temperature for no more than 6 hours (including infusion time).



Material Safety Data Sheets Environmental Risk Assessments

How Supplied/Storage & Handling arrow-down arrow-up
  • ZEJULA is available as capsules having a white body printed with “100 mg” in black ink, and a purple cap printed with “Niraparib” in white ink.
  • Each capsule contains 100 mg of niraparib free base.
  • ZEJULA capsules are packaged as
    • 90-count bottles NDC 69656-103-90
    • 30-count bottles NDC 69656-103-30
  • Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].


Download Pipeline Brochure

Harnessing the Body’s Immune System

The growing understanding of tumor cells’ ability to evade immune surveillance has led to advances in the field of immuno-oncology.1

Malignant cells manipulate a variety of physiological mechanisms involved in antigenicity, immune activation, T-cell priming and recruitment, and upregulation of checkpoint molecules.1 Many of these mechanisms may be impacted simultaneously to promote tumor cell survival.1 Immunotherapies harness the body’s own immune system to fight cancer by using different immunological pathways to enhance antitumor responses.1,2

GSK is exploring different clinical assets aimed at augmenting the immune response, reducing immune suppression, and modulating the tumor microenvironment.3,4

Immuno-Oncology Phase I Phase II Phase III

DREAMM-3: Relapsed/Refractory Multiple Myeloma alone vs Pomalidomide/Dexamethasone


DREAMM-7: Relapsed/Refractory Multiple Myeloma in Combination with Bortezomib and Dexamethasone vs Daratumumab/Bortezomib/Dexamethasone


DREAMM-9: Newly Diagnosed Multiple Myeloma in Combination with Lenalidomide, Bortezomib, and Dexamethasone


DREAMM-4: Relapsed/Refractory Multiple Myeloma in Combination With Pembrolizumab


DREAMM-5: relapsed/refractory multiple myeloma alone and in combination with GSK3174998 (OX40 agonist antibody) or GSK3359609 (ICOS agonist IgG4 antibody)


Relapsed/refractory multiple myeloma in Chinese patients


DREAMM-6: Relapsed/Refractory Multiple Myeloma in Combination With Lenalidomide Plus Dexamethasone or in Combination With Bortezomib Plus Dexamethasone


Relapsed/Refractory Multiple Myeloma in Japanese Patients


DREAMM-12: Relapsed/Refractory Multiple Myeloma in Normal or Varying Degrees of Impaired Renal Function


DREAMM-13: Relapsed/Refractory Multiple Myeloma in Normal or Varying Degrees of Impaired Hepatic Function


RUBY: Recurrent or Primary Advanced Endometrial Cancer in Combination With Chemotherapy


GARNET: Mismatch Repair Deficient (dMMR)/Microsatellite Instability High (MSI-H) Non-Endometrial Cancer Solid Tumors, Endometrial Cancer, Ovarian Cancer, and Non-Small Cell Lung Cancer (NSCLC)


IOLite: Advanced NSCLC and Solid Tumors in Combination With Niraparib (PARP Inhibitor), Cobolimab (Anti-TIM-3 Antibody), Bevacizumab, and/or Platinum-Based Doublet Chemotherapy


INDUCE-3: Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) in Combination with Pembrolizumab


INDUCE-4: Recurrent/Metastatic HNSCC in Combination with Pembrolizumab and 5-Fluorouracil (5-FU) Platinum Chemotherapy


ENTREE-Lung: Advanced NSCLC in Combination With Docetaxel


INDUCE-2: Advanced Solid Tumors in Combination With Tremelimumab


INDUCE-1: Advanced Solid Tumors Alone and in Combination With Pembrolizumab or Chemotherapy


AMBER: Melanoma, NSCLC, and Colorectal Cancer Alone and in Combination With Dostarlimab (Anti-PD-1 Antagonist)


CITRINO: Advanced Solid Tumors Alone and in Combination With Dostarlimab


Advanced Solid Tumors Alone and in Combination With Pembrolizumab


INTR@PID BTC 055: First-line treatment in combination with gemcitabine plus cisplatin in locally advanced/metastatic biliary tract cancer (BTC)


INTR@PID BTC 047: Second-line locally advanced/metastatic BTC


INTR@PID CERVICAL 017: advanced, unresectable cervical cancer that progressed during or after platinum-containing chemotherapy.


INTR@PID UROTHELIAL 152: locally advanced/metastatic urothelial cancer that progressed or recurred after platinum-containing chemotherapy


INTR@PID LUNG 037: First-line treatment in stage IV, PD-L1-high NSCLC


INTR@PID LUNG 005: Unresectable Stage III NSCLC in Combination With Concurrent Chemoradiation Therapy


INTR@PID LUNG 024: stage IV NSCLC in combination with chemotherapy


INTR@PID SOLID TUMOR 001: Locally Advanced or Metastatic Solid Tumors


INTR@PID SOLID TUMOR 008: Locally Advanced or Metastatic Solid Tumors


ENGAGE-1: Advanced Solid Tumors Alone and in Combination With Pembrolizumab


Advanced Solid Tumors in Combination With GSK3174998 (OX40 Agonist), GSK3359609 (ICOS Agonist), or Pembrolizumab


Advanced NY-ESO-1– and/or LAGE-1a–positive solid tumors


Advanced Solid Tumors Alone and In Combination with Dostarlimab

  1. Allard B, Aspeslagh S, Garaud S, et al. Immuno-oncology-101: overview of major concepts and translational perspectives. Semin Cancer Biol. 2018;52(pt 2):1-11.
  2. PhRMA. Medicines in development for immuno-oncology 2017 report. https://www.phrma.org/medicines-in-development-immuno-oncology. Accessed January 30, 2019.
  3. Tai Y-T, Anderson KC. Targeting B-cell maturation antigen in multiple myeloma. Immunotherapy. 2015;7(11):1187-1199.
  4. Knudson KM, Hicks KC, Luo X, Chen J-Q, Schlom J, Gameiro SR. M7824, a novel bifunctional anti-PD-L1/TGF trap fusion protein, promotes anti-tumor efficacy as monotherapy and in combination with vaccine. Oncoimmunology. 2018;7(5):e1426519. doi:10.1080/2162402X.2018.1426519.
  • * In-license or other partnership with third party
  • Tesaro acquisition
  • Being developed in a strategic global alliance between GSK and Merck KgaA, Darmstadt, Germany
  • Option-based alliance with Immunocore Ltd. ImmTAC is a registered trademark of Immunocore Ltd.
Synthetic Lethality

Accumulation of DNA damage and genomic instability are pervasive characteristics of human tumors and are caused by defects in DNA repair.1,2 Deficiencies in essential DNA damage repair in cancer cells may increase dependency on an alternate repair pathway for cell survival.2 Synthetically lethal therapies aim to combine pharmacologic inhibition of these alternate repair pathways with inherent defects in DNA damage repair to selectively kill tumor cells while sparing healthy tissue.2-4 GSK is investigating a clinical asset that utilizes the power of synthetically lethal interactions to fight malignant cells in a variety of cancers.

Synthetic Lethality Phase I Phase II Phase III

FIRST: Ovarian Cancer maintenance in combination with or without dostarlimab and bevacizumab following first-line treatment with Platinum-Based Chemotherapy with or without dostarlimab and bevacizumab


OVARIO: Ovarian Cancer First-Line Maintenance in Combination With Bevacizumab Following Response on Front-Line Platinum-Based Chemotherapy Plus Bevacizumab


OPAL: Platinum-Resistant Ovarian Cancer Treatment in Combination With Dostarlimab and Bevacizumab


MOONSTONE: Platinum-Based Ovarian Cancer Treatment in Combination With Dostarlimab


Neoadjuvant Treatment in HER2- and BRCAmut Localized Breast Cancer


Pharmacokinetics and Safety in Patients With Advanced Solid Tumors and Normal Hepatic Function or Moderate Hepatic Impairment


Crossover Bioavailability Study of Niarparib Tablet Compared to Niraparib Capsule in Advanced Solid Tumors

  1. Lord CJ, Ashworth A. The DNA damage response and cancer therapy. Nature. 2012;481(7381):287-294.
  2. O’Connor MJ. Targeting the DNA damage response in cancer. Mol Cell. 2015;60(4):547-560.
  3. Kelley MR, Logsdon D, Fishel ML. Targeting DNA repair pathways for cancer treatment: what’s new? Future Oncol. 2014;10(7):1215-1237.
  4. O'Neil NJ, Bailey ML, Hieter P. Synthetic lethality and cancer. Nat Rev Genet. 2017;18(10):613-623.
  • * Tesaro acquisition
  • In collaboration with ENGOT, the European Network for Gynaecological Oncological Trial groups
Cancer Epigenetics

Aberrant gene expression, regulated in large part by epigenetic mechanisms, is a hallmark of cancer.1 “Epigenetics” refers to heritable changes in gene expression that arise from changes in chromosomes without altering the DNA sequence.2 DNA methylation and posttranslational modifications of histones play key roles in regulating gene expression.1,3 Deregulation of these epigenetic mechanisms can lead to aberrant expression of oncogenes and tumor suppressors in cancer cells that can enhance proliferative signals, impair cell death, promote angiogenesis, and facilitate metastasis. GSK is investigating compounds that work by altering these epigenetic pathways.

Cancer Epigenetics Phase I Phase II

Relapsed/Refractory Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), and Chronic Myelomonocytic Leukemia (CMML)


Solid Tumors and Non-Hodgkin's Lymphoma (NHL)


Relapsed/Refractory Solid Tumors and Diffuse Large B-Cell Lymphoma (DLBCL)

  1. Kanwal R, Gupta S. Epigenetic modifications in cancer. Clin Genet. 2012;81(4):303-311.
  2. Nebbioso A, Tambaro FP, Dell’Aversana C, Altucci L. Cancer epigenetics: moving forward. PLoS Genet. 2018;14(6):e1007362.
  3. Pérez-Salvia M, Esteller M. Bromodomain inhibitors and cancer therapy: from structures to applications. Epigenetics. 2017;12(5):323-339.
  • * In-license or other partnership with third party
Cell Therapy

The physiologic role of central and peripheral tolerance mechanisms is to limit unchecked immune responses that can lead to autoimmunity.1 In cancer, these mechanisms are major limitations to effective T-cell mediated antitumor immunity.1 Oncology cell therapy uses adoptive transfer of engineered T cells that may mediate antitumor effects. In adoptive cell therapy, T cells are isolated from the patient, engineered to present an enhanced TCR that recognizes a specific antigen, and then reintroduced into the patient.1,2 This innovative approach generates T cells that may be more efficient at targeting cancer cells and may overcome the barriers of tolerance mechanisms2 GSK is developing an engineered TCR T-cell clinical asset designed to target a tumor-specific antigen and eliminate malignant cells in solid tumors and hematologic malignancies.

Oncology Cell Therapy Phase I Phase II Phase III

IGNYTE-ESO: master protocol–advanced NY-ESO-1– and/or LAGE-1a–positive synovial sarcoma and solid tumors


Relapsed/Refractory NY-ESO-1– and/or LAGE-1a–Positive Multiple Myeloma Alone and in Combination with Pembrolizumab


Advanced Myxoid/Round Cell Liposarcoma


Advanced NY-ESO-1– and/or LAGE-1a–Positive NSCLC Alone and in Combination with Pembrolizumab


Long-Term Follow-up from Previous GSK3377794 Studies

  1. Perica K, Varela JC, Oelke M, Schneck J. Adoptive T cell immunotherapy for cancer. Rambam Maimonides Med J. 2015;6(1):e0004.
  2. Sharpe M, Mount N. Genetically modified T cells in cancer therapy: opportunities and challenges. Dis Model Mech. 2015;8(4):337-350.
  • * In-license or other partnership with third party

Early Stage Pipeline

Cell Therapy - Coming Soon

Niraparib Mechanism of Action Video ( 3:48)

Immuno-Oncology MOA (4:53)

Inducible T-Cell Costimulator (2:50)

No Two Cancers are the same (0:30)

NY-ESO-1 T-cell Receptor (3:14)

Bintrafusp alfa Mechanism of Action (3:01)

Dostarlimab Mechanism of Action (3:04)

Society of Hematologic Oncology (SOHO)

September 9-12, 2020 | Virtual Meeting

American Association of Cancer Research (AACR)

June 22-24, 2020 | Virtual Meeting II

European Hematology Association (EHA)

June 11-21, 2020 | Virtual

American Society of Clinical Oncology (ASCO)

May 29-June 2, 2020 | Virtual

Controversies in Multiple Myeloma (COMy)

May 14-16, 2020 | Virtual

Oncology Nursing Society (ONS)

April 29-May 3, 2020 | Virtual

American Association of Cancer Research (AACR)

April 27, 2020 | Virtual Meeting I

Society of Gynecologic Oncology (SGO)

April 2020 | Virtual

Multidisciplinary Head and Neck Cancers Symposium (HNSCC)

February 27-29, 2020 | Scottsdale, AZ

American Society of Clinical Oncology – Gastrointestinal Cancers Symposium

January 23-25, 2020 | San Francisco, CA

San Antonio Breast Cancer Symposium (SABCS)

Dec 10–14, 2019 | San Antonio, Texas

American Society of Hematology (ASH)

December 7-10, 2019 | Orlando, FL

Connective Tissue Oncology Society (CTOS)

November 13-16, 2019 | Tokyo, Japan

The Society for Immunotherapy of Cancer (SITC)

November 8-10 2019 | Baltimore, MD

European Society of Gynaecological Oncology (ESGO)

November 2-5, 2019 | Athens, Greece

European Society for Medical Oncology (ESMO)

September 27–October 1, 2019 | Barcelona, Spain

International Association for the Study of Lung Cancer (IASLC)/World Conference on Lung Cancer (WCLC)

September 7-10, 2019 | Barcelona, Spain

Overview of Ovarian Cancer (3:04)

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