Oncology Corporate Profile
GlaxoSmithKline engages in the creation, discovery, development, manufacture, and marketing of pharmaceutical and consumer health-related products. Its Pharmaceuticals segment manufactures prescription drugs and vaccines that are used in various therapeutic areas, including central nervous system, respiratory, anti-viral, anti-bacterial, oncology and emesis, metabolic, cardiovascular, and urogenital.
|Arranon®||nelarabine||ARRANON is indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.|
|Arzerra™||ofatumumab||ARZERRA (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated:|
• in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
• for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.
|Bexxar®||tositumomab||The BEXXAR therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) is indicated for the treatment of patients with CD20 antigen-expressing relapsed or refractory, low grade, follicular, or transformed non-Hodgkin's lymphoma, including patients with Rituximab-refractory non-Hodgkin’s lymphoma. Determination of the effectiveness of the BEXXAR therapeutic regimen is based on overall response rates in patients whose disease is refractory to chemotherapy alone or to chemotherapy and Rituximab. The effects of the BEXXAR therapeutic regimen on survival are not known.|
The BEXXAR therapeutic regimen is not indicated for the initial treatment of patients with CD20 positive non-Hodgkin’s lymphoma. (See ADVERSE REACTIONS, Immunogenicity.)
The BEXXAR therapeutic regimen is intended as a single course of treatment. The safety of multiple courses of the BEXXAR therapeutic regimen, or combination of this regimen with other forms of irradiation or chemotherapy, has not been evaluated.
|Hycamtin®||topotecan hydrochloride||Hycamtin is indicated for the treatment of metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy.|
Hycamtin is indicated for the treatment of small cell lung cancer sensitive disease after failure of first-line chemotherapy.*
*In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing ?60 days (in the phase III study) or ?90 days (in the phase II studies) after chemotherapy.
Hycamtin in combination with cisplatin is indicated for the treatment of histologically confirmed Stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.
|Mekinist™||trametinib||MEKINIST is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.|
Limitation of use:
MEKINIST is not indicated for the treatment of patients who have received prior BRA F-inhibitor therapy.
|Tafinlar®||dabrafenib||TAFINLAR is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.|
Limitation of use:
TAFINLAR is not indicated for treatment of patients with wild-type BRAF melanoma.
|Tykerb®||lapatinib||TYKERB is indicated in combination with Xeloda® (capecitabine) for the treatment of patients with advanced or metastatic breast cancer whose tumors over express HER2 and who have received prior therapy including an anthracycline, a taxane, and Herceptin® (trastuzumab).|
|Votrient™||pazopanib||VOTRIENT is a kinase inhibitor indicated for the treatment of patients with:|
• advanced renal cell carcinoma.
• advanced soft tissue sarcoma who have received prior chemotherapy.
Limitations of Use:
The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated.
|Zofran®||ondansetron hydrochloride||1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ? 50 mg/m².|
2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ZOFRAN Tablets, ZOFRAN ODT Orally Disintegrating Tablets, and ZOFRAN Oral Solution are recommended even where the incidence of postoperative nausea and/or vomiting is low.
View additional information on commercial products here »
|Brand / Product||Class||Area of Study||Phase||Partnership|
|MAGE-A3||antigen-specific cancer immunotherapeutic||1st line metastatic Melanoma||III|
|GSK1120212||MEK inhibitor||1st line metastatic Melanoma||III|
|trametinib (+ dabrafenib)||MEK1/2 inhibitor + BRAF protein kinase inhibitor||Melanoma||III|
|MAGE-A3||antigen-specific cancer immunotherapeutic||Non Small Cell Lung Cancer (NSCLC)||III|
|GSK1572932A||immunotherapy||Non Small Cell Lung Cancer (NSCLC)||III|
|Arzerra? / ofatumumab||anti-CD20 monoclonal antibody (humanized)||2nd line follicular Non-Hodgkin's Lymphoma (f-NHL)||III||Genmab|
|Hycamtin? / topotecan hydrochloride||topoisomerase inhibitor||1st line metastatic Ovarian cancer||III|
|Hycamtin? / topotecan hydrochloride||topoisomerase inhibitor||Brain metastases from Non Small Cell Lung Cancer (NSCLC)||III|
|Rezonic? / casopitant||NK1 antagonist||Chemotherapy-induced & postoperative nausea & vomiting||III|
|Tykerb? / lapatinib||ErbB-2 and EGFR dual kinase inhibitor||1st line metastatic Breast cancer||III|
|Tykerb? / lapatinib||ErbB-2 and EGFR dual kinase inhibitor||Adjuvant Breast cancer||III|
|Tykerb? / lapatinib||ErbB-2 and EGFR dual kinase inhibitor||Brain metastases from Breast cancer||III|
|Tykerb? / lapatinib||ErbB-2 and EGFR dual kinase inhibitor||Head & Neck cancer (squamous)||III|
|Votrient? (+ Tykerb?) / pazopanib (+ lapatinib)||multiple tyrosine kinase inhibitor||Inflammatory Breast cancer||III|
|WT1||antigen-specific cancer immunotherapeutic||1st line metastatic Acute Myelogenous Leukemia (AML)||II|
|MAGE-A3||antigen-specific cancer immunotherapeutic||1st line metastatic Bladder cancer||II|
|WT1||antigen-specific cancer immunotherapeutic||1st line metastatic Breast cancer||II|
|foretinib / XL880||multikinase inhibitor of c-Met & VEGFR-2.||Gastric cancer||II|
|foretinib / XL880||multikinase inhibitor of c-Met & VEGFR-2.||Head & Neck cancer (squamous)||II|
|mapatumumab / HGS-ETR1||anti-TRAIL receptors 1 and 2 monoclonal antibody||Multiple Myeloma||II|
|foretinib||multikinase inhibitor of c-Met & VEGFR-2.||Non Small Cell Lung Cancer (NSCLC)||II|
|mapatumumab / HGS-ETR1||anti-TRAIL receptors 1 and 2 monoclonal antibody||Non Small Cell Lung Cancer (NSCLC)||II|
|afuresertib||AKT protein kinase inhibitor||Ovarian cancer||II|
|foretinib / XL880||multikinase inhibitor of c-Met & VEGFR-2.||Papillary Renal cell carcinoma (RCC)||II|
|Arzerra? / ofatumumab (+ CHOP)||anti-CD20 monoclonal antibody (humanized)||1st line metastatic Non-Hodgkin?s lymphoma (NHL)||II||Genmab|
|Arzerra? / ofatumumab||anti-CD20 monoclonal antibody (humanized)||Diffuse large B-cell Lymphoma (DLBCL)||II||Genmab|
|Arzerra? / ofatumumab (+ chemotherapy)||anti-CD20 monoclonal antibody (humanized)||Diffuse large B-cell Lymphoma (DLBCL)||II||Genmab|
|Tafinlar / dabrafenib||BRAF protein kinase inhibitor||Non Small Cell Lung Cancer (NSCLC)||II|
|Tykerb? / lapatinib||ErbB-2 and EGFR dual kinase inhibitor||Inflammatory Breast cancer (refractory)||II|
|Votrient? / pazopanib||multiple tyrosine kinase inhibitor||1st line metastatic Thyroid cancer||II|
|Votrient? / pazopanib||multiple tyrosine kinase inhibitor||Non Small Cell Lung Cancer (NSCLC)||II|
|Votrient? / pazopanib||multiple tyrosine kinase inhibitor||Ovarian cancer||II|
|Votrient? (+ Tykerb?) / pazopanib (+ lapatinib)||multiple tyrosine kinase inhibitor||1st line metastatic Breast cancer||II|
|Votrient? (+ Tykerb?) / pazopanib (+ lapatinib)||multiple tyrosine kinase inhibitor||Various cancer types||II|
|NY-ESO-1||antigen-specific cancer immunotherapeutic||1st line metastatic Melanoma||I|
|PRAME||antigen-specific cancer immunotherapeutic||1st line metastatic Melanoma||I|
|mapatumumab / HGS-ETR1||anti-TRAIL receptors 1 and 2 monoclonal antibody||Hepatocellular carcinoma (HCC)||I|
|afuresertib (2110183)||AKT protein kinase inhibitor||Multiple Myeloma||I|
|GSK2302032A||immunotherapy||Non Small Cell Lung Cancer (NSCLC)||I|
|PRAME||antigen-specific cancer immunotherapeutic||Resectable Non Small Cell Lung Cancer (NSCLC)||I|
|GSK2879552||LSD1/CoREST inhibitor||Small Cell Lung Cancer (SCLC)||I|
|trametinib (+ 2141795)||MEK1/2 inhibitor + AKT protein kinase inhibitor||Various cancer types||I|
|3052230||fibroblast growth factor ligand trap||Various cancer types||I|
|2849330||ErbB3 monoclonal antibody||Various cancer types||I|
|2636771||phosphatidylinositol 3-kinase inhibitor||Various cancer types||I|
|2256098||focal adhesion kinase inhibitor||Various cancer types||I|
|GSK690693||AKT inhibitor||Various cancer types||I|
|GSK2141795||AKT inhibitor||Various cancer types||I|
|lexatumumab / HGS-ETR2||antibody to TRAIL receptor 2||Various cancer types||I|
|GSK923295||centromere-associated protein E (CENP-E) inhibitor||Various cancer types||I|
|GSK461364||polo-like kinase 1 (PLK1) inhibitor||Various cancer types||I|
|Votrient? / pazopanib||multiple tyrosine kinase inhibitor||Colorectal cancer||I|
|Votrient? / pazopani (+ MK-347)5||multi-kinase angiogenesis inhibitor + PD-1 monoclonal antibody||Renal cell carcinoma (RCC)||I|
|Arzerra? / ofatumumab (+ chlorambucil)||anti-CD20 monoclonal antibody (humanized)||Chronic Lymphocytic Leukemia (CLL)||Approved|
|HGS1029||IAP inhibitor||Various cancer types||Preclinical|
|MAGE-A3||antigen-specific cancer immunotherapeutic||1st line metastatic Non Small Cell Lung Cancer (NSCLC)||Terminated|
View additional information on product candidates here »
9/20/2016 12:53 pm
(Reuters) Sept 20, 2016 - GlaxoSmithKline said on Tuesday it had chosen its head of consumer healthcare, Emma Walmsley, as its new chief executive, after several months reviewing internal and external candidates.
6/14/2016 11:05 am
(Yahoo! Finance) June 14, 2016 - Celator Pharmaceuticals, Inc. today announced positive response rate results in AML patients with FLT3 (FMS-like tyrosine kinase-3) mutation were presented at the European Hematology Association (EHA) 21st Annual Congress. The results are from the Company's Phase 3 trial of VYXEOS™ (cytarabine: daunorubicin) Liposome for Injection (also known as CPX-351) in patients with high-risk (secondary) acute myeloid leukemia (AML).
5/20/2016 11:03 am
(San Diego Union-Tribune) May 19, 2016 - A drug in clinical trials for liver diseases by a San Diego biotech company may be useful in treating acute myeloid leukemia, according to research published this week.
5/18/2016 11:05 am
(ASCO in Action) May 17, 2016 - The oncology community voiced its strong opposition to the proposed Medicare Part B demonstration project today on Capitol Hill before the Health Subcommittee of the House Energy and Commerce Committee.
5/4/2016 07:00 am
(StreetInsider) May 3, 2016 - Acceptance reinforces significant unmet need for difficult-to-treat type of pediatric acute lymphoblastic leukemia.
4/14/2016 11:04 am
(Washington Post/To Your Health) Apr 13, 2016 - Federal health officials confirmed Wednesday that the Zika virus causes a rare birth defect and other severe fetal abnormalities, marking a turning point in an epidemic that has spread to more than 40 countries and territories in the Americas and elsewhere.
4/12/2016 12:01 pm
(Medscape Medical News) Apr 12, 2016 - Most doctors do not fully understand the drug approval process for the US Food and Drug Administration (FDA) or the FDA's "breakthrough" drug classification, according to a survey published April 12 in JAMA.
4/1/2016 10:05 am
(Forbes) Mar 31, 2016 - Scientists have shown that an unusual form of genetic material can help cause blood cancers.
3/31/2016 12:20 pm
(Reuters) Mar 31, 2016 - GSK said it intended to give developing countries access to its next-generation cancer drugs by allowing competitors access to the company's intellectual property through the UN-backed Medicines Patent Pool (MPP).
3/17/2016 12:18 pm
(Reuters [UK]) Mar 17, 2016 - GlaxoSmithKline said on Thursday its Chief Executive Andrew Witty would retire in 12 months after leading the British drugmaker through a series of changes since 2008 that have failed to ignite the share price.
2/23/2016 01:01 pm
(Xconomy New York) Feb 23, 2016 - Two times, PTC Therapeutics has asked the FDA to look at an application to approve a Duchenne muscular dystrophy drug it’s been developing. And now two times, the agency has sent the South Plainfield, NJ-based company back to the drawing board.
2/12/2016 12:26 pm
(Wall Street Journal) Feb 12, 2016 - Competition Markets Authority says GSK tried to delay potential entry of competitors in U.K. generic-drugs market for antidepressant drug paroxetine.
1/21/2016 12:36 pm
(New York Times) Jan 20, 2016 - Federal prosecutors in Philadelphia said on Wednesday that they had indicted five people, including two research scientists, on charges of stealing trade secrets about drugs to treat cancer and other diseases from GlaxoSmithKline, the British drug giant.
6/11/2015 11:03 am
(BMS) June 11, 2015 - Bristol-Myers Squibb will present data for elotuzumab, an investigational immunostimulatory antibody, in relapsed or refractory multiple myeloma; Opdivo (nivolumab), in patients with relapsed or refractory lymphoid malignancies; and Sprycel (dasatinib), in chronic myeloid leukemia.
6/2/2015 04:05 pm
(Synta) June 2, 2015 - Synta Pharmaceuticals Corp. today announced updates to its clinical program for Ganetespib, a next-generation inhibitor of the chaperone protein Hsp90.
5/31/2015 07:00 pm
(Benzinga) May 31, 2015 - Pharmacyclics LLC today announced interim results from the ongoing Phase Ib/II PCYC-1129 study suggesting that ibrutinib (IMBRUVICA®) may be a safe and effective treatment for patients with chronic graft-versus-host-disease (cGVHD) who were either refractory to steroid treatment or were steroid-dependent.
5/31/2015 07:00 pm
(MarketWatch) May 31, 2015 - A combination of Biothera’s Imprime PGG and the monoclonal antibodies alemtuzumab and rituximab achieved responses in 13 of 14 (93%) patients with high-risk chronic lymphocytic leukemia, including nine (64%) complete responses. Results of this phase 1/2 study will be presented today at the American Society of Clinical Oncology (ASCO).
5/29/2015 02:02 pm
(Moffitt) May 28, 2015 - The monoclonal antibody nivolumab has shown promise as a therapeutic agent, particularly by improving the survival rates of melanoma patients.
4/29/2015 11:05 am
(Washington Post) Apr 29, 2015 - Last week, my colleagues and I, as part of the U.S. Preventive Services Task Force, shared new draft recommendations on breast cancer screening. Our recommendations are based on an in-depth review of the strongest available science regarding mammography.
4/21/2015 11:04 am
(The Guardian [UK]) Apr 21, 2015 - Dietary supplements, such as over-the-counter multivitamins, do “more harm than good” and can increase the risk of developing cancer and heart disease, according to research in the US.
4/13/2015 11:04 am
(University of Michigan) Apr 13, 2015 - University of Michigan researchers have discovered a biomarker that may be a potentially important breakthrough in diagnosing and treating prostate cancer.
4/9/2015 12:03 pm
(Health Affairs blog) Apr 8, 2015 - Drug shortages are a significant public health issue that have affected many critically important drugs including chemotherapy treatments, nutritional support preparations, and antibiotics.
3/27/2015 11:02 am
(ASH) Mar 25, 2015 - Today Representatives David McKinley (R-WV) and Lois Capps (D-CA) introduced the Patients’ Access to Treatments Act in the House of Representatives, an important first step toward removing the burden of excessive cost-sharing for Americans who need high-cost, specialty-tier medications.
3/12/2015 12:01 pm
(California Healthline) Mar 12, 2015 - House and Senate leaders are discussing a permanent fix for Medicare's sustainable growth rate formula, lawmakers and aides said Wednesday, the Wall Street Journal reports (Peterson/Radnofsky, Wall Street Journal, 3/11).
2/27/2015 12:00 pm
(MSKCC/OnCancer blog) Feb 26, 2015 - Surgery is the most common treatment for people with rectal cancer, but an operation is just the first step when it comes to restoring quality of life.
1/12/2015 11:03 am
(Bloomberg) Jan 10, 2015 - The hottest area in cancer drugs is going mainstream this year.
1/7/2015 03:02 pm
(Nasdaq) Jan 7, 2015 - Sandoz, a Novartis company, announced today that US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of its investigational biosimilar filgrastim in the US.
1/6/2015 11:04 am
(Scientific American/Nature magazine) Jan 5, 2015 - A mammoth US effort to genetically profile 10,000 tumours has officially come to an end.
12/22/2014 11:04 am
(CNBC) Dec 22, 2014 - Express Scripts says its largest plan will cover only AbbVie's hepatitis C regimen, excluding drugs from Gilead and J&J.
12/10/2014 03:03 pm
(Loyola Health Sciences) Dec 10, 2014 - Loyola researchers and collaborators have reported promising results from a novel therapeutic approach for women with estrogen-receptor-positive breast cancer.