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 histolog`ically 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. 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. 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 and advanced soft tissue sarcoma who have received prior chemotherapy. 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||Zofran® is a 5-HT3 receptor antagonist indicated for the prevention of:|
• nausea and vomiting associated with highly emetogenic cancer
chemotherapy, including cisplatin greater than or equal to 50 mg/m2
• nausea and vomiting associated with initial and repeat courses of
moderately emetogenic cancer chemotherapy.
• 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.
• postoperative nausea and/or vomiting.
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|Brand / Product||Class||Area of Study||Phase||Partnership|
|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® (+ Tykerba) / pazopanib (+ lapatinib)||multiple tyrosine kinase inhibitor||Inflammatory Breast cancer||III|
|foretinib / XL880||multikinase inhibitor of c-Met & VEGFR-2.||Head & Neck cancer (squamous)||II|
|3377794||engineered TCR||Multiple Myeloma||II|
|3377794||engineered TCR||Non Small Cell Lung Cancer (NSCLC)||II|
|3377794||engineered TCR||Ovarian cancer||II|
|Arzerra® / ofatumumab (+ CHOP)||anti-CD20 monoclonal antibody (humanized)||1st line metastatic Non-Hodgkins lymphoma (NHL)||II||Genmab|
|Arzerra® / ofatumumab (+ chemotherapy)||anti-CD20 monoclonal antibody (humanized)||Diffuse large B-cell Lymphoma (DLBCL)||II||Genmab|
|Arzerra® / ofatumumab||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|
|2879552||lysine-specific demethylase 1 (LSD1) inhibitor||Acute Myelogenous Leukemia (AML)||I|
|2857916||beta cell maturation antigen antibody drug conjugate||Multiple Myeloma||I|
|2879552||lysine-specific demethylase 1 (LSD1) inhibitor||Small Cell Lung Cancer (SCLC)||I|
|tarextumab||notch 2/3 monoclonal antibody||Small Cell Lung Cancer (SCLC)||I|
|3174998||OX40 agonist monoclonal antibody||Various cancer types||I|
|2816126||EZH2 inhibitor||Various cancer types||I|
|2849330||erb-b2 receptor tyrosine kinase 3 (ErbB3) monoclonal antibody||Various cancer types||I|
|525762||BET inhibitor||Various cancer types||I|
|brontictuzumab||notch 1 monoclonal antibody||Various cancer types||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|
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9/20/2016 05:53 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 05:20 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 05:18 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 06:26 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 06:36 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.