GlaxoSmithKline plc (GSK)

Oncology Corporate Profile

Stock Performance

40.7300
-0.1200

HQ Location

1 Franklin Plaza
Philadelphia, PA 19102

Company Description

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.

Website: http://www.gsk.com

Brand Generic Indication
Arranon®nelarabineArranon® 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®ofatumumabArzerra® (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®tositumomabThe 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 hydrochlorideHycamtin® 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®trametinibMekinist® 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®dabrafenibTafinlar® 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®lapatinibTykerb® 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®pazopanibVotrient® 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 hydrochlorideZofran® 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.

View additional information on commercial products here »

  • Brand
  • Generic
  • Investigational
Brand / Product Class Area of Study Phase Partnership
Arzerra® / ofatumumabanti-CD20 monoclonal antibody (humanized)2nd line follicular Non-Hodgkin's Lymphoma (f-NHL)IIIGenmab
Hycamtin® / topotecan hydrochloridetopoisomerase inhibitor1st line metastatic Ovarian cancerIII
Hycamtin® / topotecan hydrochloridetopoisomerase inhibitorBrain metastases from Non Small Cell Lung Cancer (NSCLC)III
Rezonic® / casopitantNK1 antagonistChemotherapy-induced & postoperative nausea & vomitingIII
Tykerb® / lapatinibErbB-2 and EGFR dual kinase inhibitor1st line metastatic Breast cancerIII
Tykerb® / lapatinibErbB-2 and EGFR dual kinase inhibitorAdjuvant Breast cancerIII
Tykerb® / lapatinibErbB-2 and EGFR dual kinase inhibitorBrain metastases from Breast cancerIII
Tykerb® / lapatinibErbB-2 and EGFR dual kinase inhibitorHead & Neck cancer (squamous)III
Votrient® (+ Tykerba) / pazopanib (+ lapatinib)multiple tyrosine kinase inhibitorInflammatory Breast cancerIII
foretinib / XL880multikinase inhibitor of c-Met & VEGFR-2.Head & Neck cancer (squamous)II
3377794engineered TCRMelanomaII
3377794engineered TCRMultiple MyelomaII
3377794engineered TCRNon Small Cell Lung Cancer (NSCLC)II
3377794engineered TCROvarian cancerII
3377794engineered TCRSarcomaII
Arzerra® / ofatumumab (+ CHOP)anti-CD20 monoclonal antibody (humanized)1st line metastatic Non-Hodgkins lymphoma (NHL)IIGenmab
Arzerra® / ofatumumab (+ chemotherapy)anti-CD20 monoclonal antibody (humanized)Diffuse large B-cell Lymphoma (DLBCL)IIGenmab
Arzerra® / ofatumumabanti-CD20 monoclonal antibody (humanized)Diffuse large B-cell Lymphoma (DLBCL)IIGenmab
Tafinlar® / dabrafenibBRAF protein kinase inhibitorNon Small Cell Lung Cancer (NSCLC)II
Tykerb® / lapatinibErbB-2 and EGFR dual kinase inhibitorInflammatory Breast cancer (refractory)II
Votrient® / pazopanibmultiple tyrosine kinase inhibitor1st line metastatic Thyroid cancerII
Votrient® / pazopanibmultiple tyrosine kinase inhibitorNon Small Cell Lung Cancer (NSCLC)II
Votrient® / pazopanibmultiple tyrosine kinase inhibitorOvarian cancerII
Votrient® (+ Tykerb®) / pazopanib (+ lapatinib)multiple tyrosine kinase inhibitor1st line metastatic Breast cancerII
Votrient® (+ Tykerb®) / pazopanib (+ lapatinib)multiple tyrosine kinase inhibitorVarious cancer typesII
2879552lysine-specific demethylase 1 (LSD1) inhibitorAcute Myelogenous Leukemia (AML)I
2857916beta cell maturation antigen antibody drug conjugateMultiple MyelomaI
2879552lysine-specific demethylase 1 (LSD1) inhibitorSmall Cell Lung Cancer (SCLC)I
tarextumabnotch 2/3 monoclonal antibodySmall Cell Lung Cancer (SCLC)I
3174998OX40 agonist monoclonal antibodyVarious cancer typesI
525762BET inhibitorVarious cancer typesI
2816126EZH2 inhibitorVarious cancer typesI
2849330erb-b2 receptor tyrosine kinase 3 (ErbB3) monoclonal antibodyVarious cancer typesI
brontictuzumabnotch 1 monoclonal antibodyVarious cancer typesI
Votrient® / pazopani (+ MK-347)5multi-kinase angiogenesis inhibitor + PD-1 monoclonal antibodyRenal cell carcinoma (RCC)I
Arzerra® / ofatumumab (+ chlorambucil)anti-CD20 monoclonal antibody (humanized)Chronic Lymphocytic Leukemia (CLL)Approved
HGS1029IAP inhibitorVarious cancer typesPreclinical

View additional information on product candidates here »

Source: http://www.gsk.com

Recent News Headlines

GlaxoSmithKline Names Insider Emma Walmsley As New Ceo

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.

Celator Pharmaceuticals® Announces Positive Results in Patients with FLT3 Mutation from the Phase 3 Trial in High-Risk Acute Myeloid Leukemia

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).

Experimental Liver Drug May Fight Cancer

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.

ASCO Explains Its Opposition to Medicare Part B Demo During Key Congressional Hearing

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.

FDA Grants Priority Review For Amgen's Supplemental Biologics License Application For BLINCYTO® (Blinatumomab)

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.

CDC Confirms Zika Virus Causes Microcephaly, Other Birth Defects

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.

Internists, Specialists Lack Knowledge About FDA Drug Approval Process

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.

Weird Loops Of Genetic Material Help Cause Cancer

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.

GlaxoSmithKline Promises Reduced Drug Patents To Help World's Poor

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).

GlaxoSmithKline's CEO Witty to Bow Out In March 2017

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.

Déjà Vu for PTC as FDA Declines to Consider Duchenne Drug App

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.

GlaxoSmithKline Fined $53 Million in Generic Drug Delay Ruling

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.

5 Accused of Stealing Drug Secrets From GlaxoSmithKline

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.

Bristol-Myers Squibb Demonstrates Commitment to Hematology and Advancing Research and Development Across Multiple Blood Cancers Through Immuno-Oncology Leadership at the 20th Congress of the European Hematology Association

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.

Synta Announces Ganetespib Program Updates

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.

Ibrutinib (IMBRUVICA®) Phase Ib/II Data Show Promise in Patients with Chronic Graft-Versus-Host-Disease

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.

Imprime PGG-MAb Combination Therapy Achieves High Response Rate in Patients with Chronic Lymphocytic Leukemia

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).

Nivolumab Treatment in Melanoma Patients has Manageable Safety Profile, Additional Immunomodulatory Agents Do Not Affect Response Rates, Say Moffitt Cancer Center Researchers

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.

New Breast Cancer Screening Guidelines Explained

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.

Vitamin Supplements Can Increase Risk of Cancer and Heart Disease

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.

Researchers Find Protein That May Signal More Aggressive Prostate Cancers

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.

Are Shortages Going Down or Not? Interpreting Data From the FDA and The University of Utah Drug Information Service

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(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.

Statement from ASH President David A. Williams, MD, on Introduction of the Patients’ Access to Treatments Act in the House of Representatives

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.

Congress Could Pursue a Permanent Medicare Physician Payment Fix

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).

New Survey Helps Doctors Better Assess Outcomes For Rectal Cancer Surgery

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(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.

The Coming Wave of New Cancer Fighting Drugs

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(Bloomberg) Jan 10, 2015 - The hottest area in cancer drugs is going mainstream this year.

Sandoz Biosimilar Filgrastim Recommended for Approval by FDA Oncologic Drugs Advisory Committee

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(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.

End of Cancer-Genome Project Prompts Rethink of Research Strategy

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(Scientific American/Nature magazine) Jan 5, 2015 - A mammoth US effort to genetically profile 10,000 tumours has officially come to an end.

Express Scripts Gives AbbVie Exclusive Hepatitis C Billing

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(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.

Novel Approach for Estrogen-receptor-positive Breast Cancer Reported

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(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.