Oncology Corporate Profile
Amgen is a biotechnology company that engages in the discovery, development, manufacture, and marketing of human therapeutics based on advances in cellular and molecular biology. It markets human therapeutic products in the areas of supportive cancer care, nephrology, inflammation, and oncology.
|Aranesp«•||darbepoetin alfa||Aranesp«• is indicated for the treatment of anemia:|
_Ê¢ associated with chronic renal failure, including patients on dialysis and patients not on dialysis.
_Ê¢ in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. Aranesp«• use has not been demonstrated in controlled clinical trials to improve symptoms of anemia, quality of life, fatigue, or patient well-being. Aranesp«• is not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.
|Blincyto__¢||blinatumomab||Blincyto__¢ is the first BiTE«• antibody construct and the first single-agent immunotherapy to be approved by the U.S. Food and Drug Administration (FDA).3 BLINCYTO was granted breakthrough therapy and priority review designations by the FDA, and is now approved in the U.S. for the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)|
|Kepivance«•||palifermin||Kepivance«• is indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support. The safety and efficacy of Kepivance«• have not been established in patients with non-hematologic malignancies.|
|Neulasta«•||pegfilgrastim||Neulasta«• is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.|
NEUPOGEN«• is indicated to decrease the incidence of infection_Ê_ as manifested by febrile neutropenia_Ê_ in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever. NEUPOGEN«• is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with AML. NEUPOGEN«• is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae_Ê_ eg_Ê_ febrile neutropenia_Ê_ in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation. NEUPOGEN«• is indicated for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. NEUPOGEN«• is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (eg_Ê_ fever_Ê_ infections_Ê_ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia_Ê_ cyclic neutropenia_Ê_ or idiopathic neutropenia.
|Nplate__¢||romiplostim||Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts.|
|Vectibix«•||panitumumab||Vectibix__¢ is indicated as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. The effectiveness of Vectibix__¢ as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix__¢.|
View additional information on commercial products here »
|Brand / Product||Class||Area of Study||Phase||Partnership|
|motesanib diphosphate / AMG 706||VEGFR1-3, PDGFR, c-Kit inhibitor (oral)||1st line metastatic Non Small Cell Lung Cancer (NSCLC)||III||Millennium|
|AMG 386 (+ paclitaxel)||Fc-peptide fusion protein targeting angiopoietins (peptibody)||2nd line metastatic Ovarian cancer||III|
|ABP 980||(trastuzumab biosimilar||Breast cancer||III|
|ABP 494||bevacizumab biosimilar||Colorectal cancer||III||Allergan|
|rilotumumab / AMG 102||anti-hepatocyte growth factor/scatter factor (HGF/SF) monoclonal antibody||Gastric cancer||III|
|ABP 215||bevacizumab biosimilar||Non Small Cell Lung Cancer (NSCLC)||III||Allergan|
|Trebananib||peptibody inhibitor||Ovarian cancer||III|
|Kyprolis / carfilzomib||proteasome inhibitor||Refractory multiple Myeloma||III|
|Vectibixa / panitumumab||anti-EGFR monoclonal antibody (humanized)||1st line metastatic Colorectal cancer||III|
|Vectibixa / panitumumab||anti-EGFR monoclonal antibody (humanized)||1st line metastatic Head & Neck cancer||III|
|Vectibixa / panitumumab||anti-EGFR monoclonal antibody (humanized)||2nd line metastatic Colorectal cancer||III|
|Vectibixa / panitumumab||anti-EGFR monoclonal antibody (humanized)||2nd line metastatic Head & Neck cancer||III|
|Xgeva / denosumab / AMG 162||anti-RANKL antibody||Bone loss in Breast cancer||III|
|Xgeva / denosumab / AMG 162||anti-RANKL antibody||Multiple Myeloma||III|
|Xgeva / denosumab / AMG 162||anti-RANKL antibody||Prevention of bone metastases in Breast cancer||III|
|motesanib diphosphate / AMG 706||VEGFR1-3, PDGFR, c-Kit inhibitor (oral)||1st line metastatic Breast cancer||II||Millennium|
|ganitumab / AMG 479||insulin-like growth factor-1 receptor (IGF-1R) inhibitor (monoclonal antibody)||Breast cancer||II|
|adecatumumab / MT201||anti-EpCAM monoclonal antibody||Colorectal cancer||II||EMD Serono|
|ganitumab / AMG 479||insulin-like growth factor-1 receptor (IGF-1R) inhibitor (monoclonal antibody)||Ewing's Sarcoma||II|
|AMG 386||Fc-peptide fusion protein targeting angiopoietins (peptibody)||Hepatocellular carcinoma (HCC)||II|
|AMG 386||Fc-peptide fusion protein targeting angiopoietins (peptibody)||Neo-adjuvant Breast cancer||II|
|conatumumab / AMG 655||pro-apoptotic TRAIL receptor-2 agonist||Neo-adjuvant Breast cancer||II|
|ganitumab / AMG 479||insulin-like growth factor-1 receptor (IGF-1R) inhibitor (monoclonal antibody)||Small Cell Lung Cancer (SCLC)||II|
|Blincyto / blinatumomab||anti-CD19 monoclonal antibody (surface antigen specific for B cells)||2nd line metastatic Acute Lymphocytic Leukemia (ALL)||II|
|Nplate / romiplostim||thrombopoietin agonist||Chemotherapy-induced thrombocytopenia in Lymphoma||II|
|Nplate / romiplostim||thrombopoietin agonist||Chemotherapy-induced thrombocytopenia in NSCLC||II|
|Nplate / romiplostim||thrombopoietin agonist||Myelodysplastic Syndrome (MDS)||II|
|Vectibixa / panitumumab||anti-EGFR monoclonal antibody (humanized)||Locally advanced Head & Neck cancer||II|
|adecatumumab (+ docetaxel) / MT201||anti-EpCAM monoclonal antibody||1st line metastatic Breast cancer||I||EMD Serono|
|dulanermin / rhApo2L/TRAIL||death receptors DR4 and DR5 inhibitor||1st line metastatic Colorectal cancer||I||Genentech / Roche|
|MEDI-565 (MT111)||CEA BiTE antibody||1st line metastatic Colorectal cancer||I||MedImmune|
|AMG 330||anti-BCMA x anti-CD3 bispecific antibody||Acute Myelogenous Leukemia (AML)||I|
|AMG 595||anti-EGFRvIII antibody drug conjugate||Glioblastoma Multiforme (GBM)||I|
|AMG 595||tubulin inhibitor||Glioma||I|
|AMG 420||anti-BCMA x anti-CD3 bispecific antibody||Multiple Myeloma||I|
|AMG 224||antibody drug conjugate||Multiple Myeloma||I|
|oprozomib||oral proteasome inhibitor||Multiple Myeloma||I|
|rilotumumab / AMG 102||anti-hepatocyte growth factor/scatter factor (HGF/SF) monoclonal antibody||Non Small Cell Lung Cancer (NSCLC)||I|
|dulanermin / rhApo2L/TRAIL||death receptors DR4 and DR5 inhibitor||Non-Hodgkin's Lymphoma (NHL)||I||Genentech / Roche|
|AMG 176||small molecule||Various cancer types||I|
|AMG 211||anti-BCMA x anti-CD3 bispecific antibody||Various cancer types||I||MedImmune|
|AMG 319||pi3k kinase inhibitor||Various cancer types||I|
|AMG 900||aurora kinases A, B, and C inhibitor||Various cancer types||I|
|AMG 208||c-Met inhibitor||Various cancer types||I|
|AMG 337||c-Met kinase inhibitor||Various cancer types||I|
|dulanermin / rhApo2L/TRAIL||death receptors DR4 and DR5 inhibitor||Various cancer types||I||Genentech / Roche|
|MT110||EpCAM (CD326) antibody||Various cancer types||I|
|MT293 (D93/TRC093)||IgG1 monoclonal antibody||Various cancer types||I||TRACON Pharmaceuticals|
|AMG 820||IgG2 c-fms antagonistic antibody (humanized)||Various cancer types||I|
|rilotumumab / AMG 102||anti-hepatocyte growth factor/scatter factor (HGF/SF) monoclonal antibody||Various cancer types||I|
|AMG 780||anti-angiopoietin antibody||Various cancer types||I|
|Imlygic / talimogene laherparepvec||oncolytic immunotherapy (derived from HSV-1)||Melanoma||I|
|Kyprolis / carfilzomib||proteasome inhibitor||Multiple Myeloma||I|
|Kyprolis / carfilzomib||proteasome inhibitor||Small Cell Lung Cancer (SCLC)||I|
|MT228 (MORAb-028)||IgM monoclonal antibody (humanized)||1st line metastatic Melanoma||Preclinical||Morphotek|
|MT110||EpCAM (CD326) antibody||Various cancer types||Preclinical||MedImmune|
View additional information on product candidates here »
10/21/2016 07:03 am
(TheStreet) Oct 20, 2016 - Study met primary endpoint of non-inferiority versus zoledronic acid in delaying bone complications known as skeletal-related events.
10/6/2016 11:18 am
(Amgen) Oct 5, 2016 - Interim data from Phase 2 trial provides further insight into Imlygic® (talimogene laherparepvec) as a potential combination partner with a checkpoint inhibitor for patients with advanced melanoma: retrospective analyses of key studies evaluating Vectibix® (panitumumab) combination regimen in first- and second-line metastatic colorectal cancer evaluate impact of tumor site of origin on treatment efficacy.
9/30/2016 11:41 am
(PharmaTimes [UK]) Sept 30, 2016 - Patients with lung cancer will not be able to access Eli Lilly's Portrazza on the National Health Service in England and Wales, after a final rejection from the National Institute for Health and Care Excellence.
9/29/2016 11:20 am
(Yahoo! Finance) Sept 28, 2016 - Amgen today announced positive top-line results for erenumab (AMG 334) from a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of erenumab in migraine prevention (ARISE).
9/27/2016 10:41 am
(Amgen) Sept 27, 2016 - Amgen today announced top-line results of the Phase 3 CLARION trial, which evaluated an investigational regimen of KYPROLIS® (carfilzomib), melphalan and prednisone (KMP) versus Velcade® (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant.
9/27/2016 10:34 am
(Reuters) Sept 27, 2016 - Amgen Inc said on Tuesday its multiple myeloma drug, Kyprolis, did not fare better than Takeda Pharmaceutical Co Ltd's older therapy Velcade in a study involving patients who had not yet been treated for the disease.
9/16/2016 11:10 am
(Firstpost/Press Trust India [Hyderabad, India]) Sept 16, 2016 - Dr Reddy's Laboratories has expanded its strategic collaboration with US-based independent biotechnology firm Amgen to market and distribute in India three of latter's medicines, used in the therapy areas of oncology and osteoporosis.
9/1/2016 11:13 am
(Amgen) Sept 1, 2016 - Amgen and Boehringer Ingelheim today announced that Amgen has acquired global development and commercial rights from Boehringer Ingelheim for BI 836908 (AMG 420), a bispecific T cell engager (BiTE®) that targets B-cell maturation antigen (BCMA), a potential target for multiple myeloma.
8/31/2016 11:16 am
(Boston Globe/Associated Press) Aug 31, 2016 - US regulators on Tuesday approved the first lower-cost version of Enbrel, a blockbuster anti-inflammatory drug from Amgen that is among the top-selling drugs in the world.
8/25/2016 11:45 am
(TheStreet) Aug 25, 2016 - An Amgen drug to treat secondary hyperparathyroidism was rejected by U.S. regulators Wednesday but the biotech company offered no public explanation for why the drug's marketing application was denied.
8/17/2016 11:26 am
(Bloomberg) Aug 16, 2016 - Amgen Inc., Sanofi and Regeneron Pharmaceuticals Inc. would need to cut prices on their new cholesterol-lowering drugs by more than two-thirds to make them cost-effective to use in the U.S., a study found.
8/9/2016 11:15 am
(Reuters) Aug 9, 2016 - Britain's cost-effectiveness agency NICE has recommended use of a virus-based melanoma drug from Amgen, reversing an earlier negative decision after the company provided further information.
8/8/2016 11:27 am
(NASDAQ/Dow Jones Business News) Aug 5, 2016 - Drugmaker AbbVie Inc. has filed a patent-infringement lawsuit against rival Amgen Inc. seeking to halt looming sales of a lower-priced replica of AbbVie's top-selling drug, Humira.
8/2/2016 08:41 am
(Amgen) Aug 2, 2016 - Amgen and Advaxis, Inc. today announced a global agreement for the development and commercialization of Advaxis' ADXS-NEO, a novel, preclinical investigational cancer immunotherapy treatment that is designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor.
7/21/2016 10:42 am
(Reuters) July 21, 2016 - Amgen Inc and Allergan Plc said their copycat version of Roche Holding AG's blockbuster cancer treatment, Herceptin, was found as effective as the original in a late-stage study.
7/19/2016 11:16 am
(Reuters) July 19, 2016 - U.S. regulators have declined to approve Novartis' so-called biosimilar copy of Amgen's Neulasta drug that fights infections in cancer patients, the Swiss drugmaker said on Tuesday.
7/14/2016 11:17 am
(Reuters) July 13, 2016 - Novartis AG's cheaper version of Amgen Inc's arthritis drug Enbrel is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday.
7/14/2016 10:56 am
(Amgen) July 13, 2016 - Amgen and Daiichi Sankyo Company, Limited today announced the execution of an exclusive agreement to commercialize nine biosimilars in Japan. The deal includes several biosimilars in late-stage development, including biosimilars of adalimumab, bevacizumab and trastuzumab.
7/11/2016 10:45 am
(Reuters) July 11, 2016 - Novartis AG's cheaper version of Amgen Inc's blockbuster arthritis drug Enbrel is highly similar in potency and safety to the original, according to a review by Food and Drug Administration staff.
7/8/2016 11:25 am
(Reuters) July 8, 2016 - Amgen Inc's biosimilar form of AbbVie Inc's arthritis drug Humira, the world's top-selling medicine, is similarly potent and safe as the original product, according to a preliminary review by staff members of the U.S. Food and Drug Administration.
7/5/2016 10:47 am
(PharmaTimes [UK]) July 5, 2016 - European regulators have cleared the use of Amgen's Kyprolis in combination with just dexamethasone to treat certain adults with multiple myeloma.
7/5/2016 07:17 am
(Amgen) July 3, 2016 - Head-to-head phase 3 trial demonstrated superiority of Kyprolis and dexamethasone over Velcade® (bortezomib) and dexamethasone in patients with relapsed multiple myeloma; new indication allows Kyprolis to be used in combination with dexamethasone alone for appropriate patients.
6/27/2016 11:50 am
(Takeda) June 24, 2016 - Rights for molecules / products including AMG403 and AMG386 will be returned to Amgen, effective immediately.
6/10/2016 11:05 am
(European Pharmaceutical Review) June 10, 2016 - Amgen has announced new data from a prespecified interim analysis of the Phase III TOWER study, in which Blincyto (blinatumomab) demonstrated an almost two-times increase in median overall survival (OS) compared to standard of care (SOC) in patients with B-cell precursor acute lymphoblastic leukaemia.
6/9/2016 11:35 am
(CNBC) June 9, 2016 - Amgen said Wednesday that it has seen positive results for erenumab (aka AMG 334), the chronic-migraine prevention drug it has been developing with Novartis.
6/4/2016 05:45 pm
(NASDAQ) June 3, 2016 - Amgen today announced the launch of KYPROLIS CENTRAL, an online media resource about the impact of living with relapsed or refractory multiple myeloma.
6/3/2016 01:01 pm
(St. Jude Children's) June 3, 2016 - St. Jude Children’s Research Hospital investigators report promising preliminary results at the annual meeting of ASCO for an experimental monoclonal antibody when combined with chemotherapy for newly diagnosed patients.
5/31/2016 11:02 am
(University of Würzburg [Germany]) May 30, 2016 - Cancer researchers have identified new genetic drivers of adrenal cancer by performing a comprehensive genomic analysis as part of the "Cancer Genome Atlas Research Network.”
5/27/2016 10:03 am
(New York Times) May 27, 2016 - It's a Catch-22: The longer we live, the more people will get the disease.
5/26/2016 06:04 am
(The Telegraph/Agence France-Presse [UK]) May 26, 2016 - The global financial crisis may have caused an additional 500,000 cancer deaths from 2008 to 2010, according to a new study, with patients locked out of treatment because of unemployment and healthcare cuts.
5/25/2016 11:03 am
(CancerCare) May 25, 2016 - CancerCare today announced the launch of the first-ever Acute Myeloid Leukemia Awareness Month to be held in June. The goal of the campaign is to put a spotlight on the disease, a rare and difficult-to-treat blood cancer that typically affects older adults.
5/18/2016 12:04 pm
(Xconomy Boston) May 17, 2016 - Agios Pharmaceuticals rode a wide-ranging partnership with Celgene to a big IPO a few years ago. Today the two companies are partnering once again in a deal that will see Agios try its hand at the increasingly competitive field of cancer immunotherapy.
5/6/2016 11:04 am
(American Academy of Sleep Medicine) May 5, 2016 - A new study reports that short sleep duration combined with frequent snoring reported prior to cancer diagnosis may influence subsequent breast cancer survival.
5/5/2016 11:05 am
(Wall Street Journal) May 4, 2016 - An advisory panel to the Food and Drug Administration overwhelmingly endorsed mandatory training for doctors who prescribe opioid painkillers, in an effort to stem what has become a national epidemic of deaths and addiction from the drugs.
5/5/2016 11:01 am
(Morningstar) May 4, 2016 - SELLAS Life Sciences Group today announced that results from a Phase 2 trial of the Company's WT1 cancer vaccine in patients with malignant pleural mesothelioma (MPM) were presented at the plenary session of the iMig 2016 Conference, being held May 1-4, 2016, in Birmingham, UK.
5/2/2016 11:01 am
(Discover/University of Minnesota) Apr 28, 2016 - A new study led by researchers at the University of Minnesota and Nantes University Hospital in France shows that the bacteria in people’s gut may predict their risk of life-threatening blood infections following high-dose chemotherapy.
4/19/2016 01:05 pm
(Reuters) Apr 18, 2016 - Some cancer patients may turn down care that could ease their pain and improve their quality of life because they think this type of “palliative” treatment amounts to giving up and simply waiting to die, a small Canadian study suggests.
4/19/2016 01:04 pm
(PM360) Apr 19, 2016 - Triphase Accelerator Corporation, a private drug development company dedicated to advancing novel compounds through Phase 2 proof-of-concept, today announced positive results from its ongoing Phase 1 proof-of-concept study evaluating marizomib in combination with bevacizumab in patients with WHO grade IV malignant glioma.
4/15/2016 11:00 am
(ESMO) Apr 15, 2016 - Important differences of up to 47% in the expression rates of biomarkers between the primary tumour and metastatic sites were detected using comprehensive molecular profiling of non-small-cell lung cancer (NSCLC) samples.
4/5/2016 11:01 am
(UCLA/Jonsson CCC) Apr 4, 2016 - UCLA researchers have developed a promising method to assess how changes in the immune response can help predict the effectiveness of a new immunotherapy in people with glioblastoma (GBM), the most common and deadly type of brain cancer.
4/5/2016 11:01 am
(MedPage Today/The Gupta Guide) Apr 4, 2016 - Mantle cell lymphoma (MCL) patients who developed primary or acquired resistance to ibrutinib (Imbruvica) had poor clinical outcomes and no other post-ibrutinib chemotherapy appeared to offer much in the way of salvage, based on an international study.
4/1/2016 11:01 am
(COA) Apr 1, 2016 - From InsideHealthPolicy.com… CMS this week issued Oncology Care Model notices to practices accepted to that demonstration, industry sources said.
3/30/2016 11:05 am
(InternetMedicine.com) Mar 29, 2016 - Recently, Italy’s National Institute of Rome Tumori Regina Elena, the country’s top cancer surgical center, became the first hospital in the nation to use customized titanium implants to repair bones damaged by bone cancer.
3/30/2016 11:04 am
(Bloomberg Gadfly) Mar 30, 2016 - Bernie Sanders is worrying millionaires, billionaires and now drug patent holders.
3/28/2016 12:00 pm
(ACS) Mar 28, 2016 - First study to compare costs of cigarettes to e-cigarettes.
3/28/2016 11:03 am
(STAT) Mar 28, 2016 - A new study shows that patients with terminal cancer tend to live longer when they choose to die at home instead of in the hospital.
3/24/2016 11:01 am
(STAT) Mar 24, 2016 - The operation is so terrifying some call it MOAS: the Mother of All Surgeries. It can take 16 hours. The risk of complications is high. And after 30 years of research, doctors are still arguing about how well it works.
3/22/2016 12:00 pm
(ESMO) Mar 21, 2016 - The latest article to appear on ESMO Open highlights ESMO's hope that the 2015 WHO Model List of Essential Medicines (EML) will empower oncologists and advocates to demand routine availability of the medicines considered essential to guarantee quality care of cancer patients.
3/17/2016 11:01 am
(MedPage Today/The Gupta Guide) Mar 16, 2016 - Adding 6 months of androgen suppression (AS) to radiation therapy improved biochemical disease-free survival in high-risk localized prostate cancer patients – even at radiation doses of 78 Gy – and it did so with acceptable adverse effects, according to a study reported in the Journal of Clinical Oncology.
3/16/2016 12:04 pm
(Reuters) Mar 16, 2016 - A first-in-class melanoma drug from Amgen based on a tumor-killing virus has been deemed not worth using on Britain's state health service by the country's cost-effectiveness agency NICE.