Beruflich Dokumente
Kultur Dokumente
Bladder Cancer
Product Name Sponsor Indication Development Phase
ANG 1005 Angiochem brain metastases from breast cancer and Phase II
(peptide-paclitaxel conjugate) Montreal, Canada NSCLC, recurrent glioblastoma (Fast Track) www.angiochem.com
Orphan Drug
antineoplaston A10/AS2-1 Burzynski Research Institute diffuse intrinsic brainstem glioma Phase II
Orphan Drug Houston, TX www.burzynskiresearch.com
Breast Cancer
Product Name Sponsor Indication Development Phase
buparlisib (BKM120) Novartis Pharmaceuticals metastatic breast cancer (2nd-line) Phase III
(PI3K inhibitor) East Hanover, NJ (ER-positive aromatase inhibitor (AI)- www.novartis.com
resistant mTOR nave) (combination therapy)
(see also brain, solid tumors)
docetaxel injection concentrate, Teikoku Pharma USA breast cancer application submitted
non-alcohol formula San Jose, CA (see also head/neck, lung, prostate, stomach) www.teikokuusa.com
etirinotecan pegol (NKTR-102) Nektar Therapeutics metastatic breast cancer (Fast Track) Phase III
(PEGylated irinotecan) San Francisco, CA (see also colorectal, ovarian) www.nektar.com
glembatumumab vedotin CellDex Therapeutics triple-negative breast cancer (Fast Track) Phase II
(antibody drug conjugate) Hampton, NJ (see also skin) www.celldex.com
tesevatinib (KD019) Kadmon Pharmaceuticals HER2-positive metastatic breast cancer Phase I/II
(TKI inhibitor) Warrendale, PA (see also lung) www.kadmon.com
Zytiga Janssen Research & Development metastatic ER-positive HER2 negative Phase II
abiraterone acetate Raritan, NJ breast cancer in post-menopausal women www.janssenrnd.com
Colorectal Cancer
Product Name Sponsor Indication Development Phase
etirinotecan pegol (NKTR-102) Nektar Therapeutics colorectal cancer (2nd-line) Phase II completed
(PEGylated irinotecan) San Francisco, CA (see also breast, ovarian) www.nektar.com
Stivarga Bayer HealthCare Pharmaceuticals colorectal cancer with resected liver metastases Phase III
regorafenib Whippany, NJ (see also kidney, liver) www.healthcare.bayer.com
docetaxel injection concentrate, Teikoku Pharma USA head and neck cancer application submitted
non-alcohol formula San Jose, CA (see also breast, lung, prostate, stomach) www.teikokuusa.com
Gilotrif Boehringer Ingelheim Pharmaceuticals squamous cell carcinoma of the head and neck Phase III
afatinib Ridgefield, CT (see also brain, lung) www.boehringer-ingelheim.com
Head and Neck Cancer
Product Name Sponsor Indication Development Phase
INO-3112 Inovio Pharmaceuticals head and neck cancer caused by HPV Phase I/II
(cancer immunotherapy) Plymouth Meeting, PA types 16 and 18 www.inovio.com
(see also other)
interleukin-12 gene therapy OncoSec Medical metastatic head and neck cancer Phase II
San Diego, CA (see also breast, skin) www.oncosec.com
MEDI4736 MedImmune squamous cell head and neck cancer (2nd-line) Phase III
(anti-PD-L1 mAb) Gaithersburg, MD (see also lung, solid tumors) www.medimmune.com
MGA271 Macrogenics squamous cell cancer of the head and neck Phase I
(CD276 protein inhibitor) Rockville, MD (combination therapy) www.macrogenics.com
(see also lung, skin)
Opdivo Bristol-Myers Squibb head and neck cancer (2nd-line) Phase III
nivolumab Princeton, NJ (see also bladder, brain, colorectal, hematological, www.bms.com
kidney, liver, lung, lymphoma, skin, solid tumors,
stomach, other)
Reolysin Oncolytics Biotech platinum-refractory head and neck cancer Phase III
pelareorp Calgary, Canada (see also brain, colorectal, lung, myeloma, www.oncolyticsbiotech.com
ovarian, other, pancreatic)
selinexor (oral) Karyopharm Therapeutics head and neck squamous cell carcinoma Phase II
(XPO1 antagonist) Newton, MA (see also brain, hematological, leukemia, lymphoma, www.karyopharm.com
myeloma, prostate, sarcoma, other)
Hematological Malignancies
Product Name Sponsor Indication Development Phase
BPX-501 Bellicum Pharmaceuticals adjunct T-cell therapy following bone marrow Phase I/II
(T-cell replacement therapy) Houston, TX transplantation in hematological malignancies www.bellicum.com
rexlemestrocel-L Mesoblast for bone marrow regeneration in patients with Phase III
(allogeneic autologous New York, NY hematological malignancies undergoing bone www.mesoblast.com
mesenchymal precursor cells) marrow transplantation
Orphan Drug
Hematological Malignancies
Product Name Sponsor Indication Development Phase
SL-401 Stemline Therapeutics blastic plasmacytoid dendritic cell neoplasm, Phase I/II
(IL-3R inhibitor) New York, NY advanced high risk myeloproliferative neoplasm www.stemline.com
(see also leukemia)
Kidney Cancer
Product Name Sponsor Indication Development Phase
Nexavar Bayer HealthCare Pharmaceuticals renal cell carcinoma (adjuvant) Phase III
sorafenib Whippany, NJ (see also other) www.healthcare.bayer.com
Opdivo nivolumab + Bristol-Myers Squibb renal cell carcinoma (1st-line) Phase III
Yervoy ipilimumab Princeton, NJ (see also lung, skin, solid tumors) www.bms.com
varlilumab Celldex Therapeutics metastatic clear cell renal cell carcinoma Phase I/II
(CD27 antigen inhibitor) Hampton, NJ (combination therapy) www.celldex.com
(see also hematological, skin)
Leukemia
Product Name Sponsor Indication Development Phase
Arzerra Novartis Pharmaceuticals CLL (maintenance therapy), CLL (relapse) Phase III
ofatumumab East Hanover, NJ (see also lymphoma) www.novartis.com
Orphan Drug
EPZ-5676 Celgene ALL and AML with altered MLL gene Phase I
(DOT1L inhibitor) Summit, NJ www.celgene.com
Orphan Drug Epizyme www.epizyme.com
Cambridge, MA
Imbruvica Janssen Research & Development relapsed/refractory CLL (combination therapy), Phase III
ibrutinib Raritan, NJ treatment nave CLL, CLL (1st-line) (combination therapy) www.janssenrnd.com
Orphan Drug (see also lymphoma)
AML Phase II
www.baxalta.com
Leukemia
Product Name Sponsor Indication Development Phase
Liver Cancer
Product Name Sponsor Indication Development Phase
AD-p53 gene therapy MultiVir liver metastases from colorectal cancer Phase I
San Diego, CA www.multivir.com
melphalan drug delivery system Delcath Systems secondary liver cancer arising from application submitted
(drug-device combination) New York, NY metastatic ocular melanoma www.delcath.com
Orphan Drug
PDT with Photofrin Concordia Laboratories unresectable advanced perihilar Phase III
porfimer sodium Toronto, Canada cholangiocarcinoma Bismuth type III/IV www.pinnaclebiologics.com
Orphan Drug Pinnacle Biologics
Chicago, IL
Lung Cancer
Product Name Sponsor Indication Development Phase
Gilotrif Boehringer Ingelheim Pharmaceuticals squamous cell carcinoma of the lung Phase III
afatinib Ridgefield, CT (see also brain, head/neck) www.boehringer-ingelheim.com
NSCLC Phase I
www.medimmune.com
Reolysin Oncolytics Biotech NSCLC, squamous cell carcinoma of the lung Phase II
pelareorp Calgary, Canada (see also brain, colorectal, head/neck, www.oncolyticsbiotech.com
myeloma, ovarian, other, pancreatic)
Lung Cancer
Product Name Sponsor Indication Development Phase
mesothelioma Phase II
www.boehringer-ingelheim.com
Lymphoma
Product Name Sponsor Indication Development Phase
ABC294640 RedHill Biopharma diffuse large B-cell lymphoma (DLBCL) Phase I/II
(sphingosine kinase inhibitor) Tel Aviv, Israel www.redhillbio.com
DLBCL Phase II
www.healthcare.bayer.com
Imbruvica Janssen Research & Development relapsed/refractory mantle cell lymphoma, Phase III
ibrutinib Raritan, NJ treatment nave mantle cell lymphoma www.janssenrnd.com
(combination therapy), relapsed/refractory
indolent NHL (combination therapy),
newly-diagnosed non-germinal center
B-cell subtype of DLBCL, previously treated
Waldenstrom's macroglobulinemia
(combination therapy)
(see also leukemia)
Multiple Myeloma
Product Name Sponsor Indication Development Phase
daratumumab Janssen Research & Development double refractory multiple myeloma application submitted
(IgG1k mAb) Raritan, NJ (Breakthrough Therapy) (Fast Track) www.janssenrnd.com
Kyprolis Onyx Pharmaceuticals relapsed multiple myeloma (combination therapy) application submitted
carfilzomib South San Francisco, CA (see also leukemia, myeloma) www.onyx.com
Orphan Drug
melphalan intravenous Spectrum Pharmaceuticals multiple myeloma autologous stem cell application submitted
(Captisol-enabled melphalan) Henderson, NV transplantation www.sppirx.com
Orphan Drug
Ovarian Cancer
Product Name Sponsor Indication Development Phase
etirinotecan pegol (NKTR-102) Nektar Therapeutics platinum-resistant ovarian cancer Phase II completed
(PEGylated irinotecan) San Francisco, CA (see also breast, colorectal) www.nektar.com
Orphan Drug
Yondelis Janssen Research & Development relapsed ovarian cancer Phase III
trabectedin Raritan, NJ (see also sarcoma) www.janssenrnd.com
Orphan Drug
Pancreatic Cancer
Product Name Sponsor Indication Development Phase
algenpantucel-L NewLink Genetics pancreatic cancer (resected) (Fast Track), Phase III
(immunotherapy vaccine) Ames, IA pancreatic cancer (borderline resectable of www.newlinkgenetics.com
Orphan Drug locally advanced unresectable)
evofosfamide (TH-302) EMD Serono pancreatic cancer (Fast Track) Phase III
(hypoxia-activated prodrug) Rockland, MA (see also brain, hematological, lung, sarcoma, skin) www.emdserono.com
Orphan Drug Threshold Pharmaceuticals www.thresholdpharm.com
South San Francisco, CA
glufosfamide Eleison Pharmaceuticals metastatic pancreatic cancer (Fast Track) Phase III
Orphan Drug St. Petersburg, FL www.eleison-pharma.com
MM-398 Baxalta metastatic pancreatic cancer (1st-line) (Fast Track) application submitted
(encapsulated irinotecan Cambridge, MA (see also brain, solid tumors) www.baxalta.com
nanotherapeutic)
Orphan Drug
polyclonal antibody stimulator Cancer Advances pancreatic cancer Phase III completed
(G17DT) Durham, NC (see also colorectal, stomach) www.canceradvancesinc.com
Orphan Drug
custirsen (OGX-111) OncoGenex Pharmaceuticals metastatic castration-resistant prostate cancer Phase III
(antisense olignucleotide) Bothell, WA (2nd-line) www.oncogenex.com
Prostate Cancer
Product Name Sponsor Indication Development Phase
docetaxel injection concentrate, Teikoku Pharma USA prostate cancer application submitted
non-alcohol formula San Jose, CA (see also breast, head/neck, lung, stomach) www.teikokuusa.com
JNJ927/ARN-509 Janssen Research & Development castration-resistant prostate cancer, Phase III
(androgen receptor antagonist) Raritan, NJ treatment nave metastatic www.janssenrnd.com
castration-resistant prostate cancer
(combination therapy)
pasireotide long acting release Novartis Pharmaceuticals castration-resistant prostate cancer Phase I/II
(SOM230) East Hanover, NJ (see also other, skin) www.novartis.com
Sarcoma
Product Name Sponsor Indication Development Phase
evofosfamide (TH-302) EMD Serono soft tissue sarcoma (Fast Track) Phase III
(hypoxia-activated prodrug) Rockland, MA (see also brain, hematological, lung, pancreatic, skin) www.emdserono.com
Orphan Drug Threshold Pharmaceuticals www.thresholdpharm.com
South San Francisco, CA
Yondelis Janssen Research & Development soft tissue sarcoma application submitted
trabectedin Raritan, NJ (see also ovarian) www.janssenrnd.com
Orphan Drug
Skin Cancer
Product Name Sponsor Indication Development Phase
eltrapuldencel-T (CLBS20) Caladrius Biosciences metastatic melanoma (Fast Track) Phase III
(dendritic cell immunotherapy) New York, NY www.caladrius.com
Orphan Drug
pasireotide long acting release Novartis Pharmaceuticals merkel cell carcinoma, metastatic melanoma Phase I
(SOM230) East Hanover, NJ (combination therapy) www.novartis.com
(see also prostate, other)
talimogene laherparepvec Amgen regionally and distantly metastatic melanoma application submitted
(cancer immunotherapy) Thousand Oaks, CA www.amgen.com
Solid Tumors
Product Name Sponsor Indication Development Phase
CGM097 Novartis Pharmaceuticals solid tumors with p53 wild type status Phase I
(p53/MDM2-interaction inhibitor) East Hanover, NJ www.novartis.com
Stomach Cancer
Product Name Sponsor Indication Development Phase
docetaxel injection concentrate, Teikoku Pharma USA gastric adenocarcinoma application submitted
non-alcohol formula San Jose, CA (see also breast, head/neck, lung, prostate) www.teikokuusa.com
NeuVax Galena Biopharma gastric carcinoma (HER2 IHC 1+/2+ or 3+) Phase I completed
nelipepimut-S Portland, OR (see also breast) www.galenabiopharma.com
polyclonal antibody stimulator Cancer Advances gastric cancer Phase III completed
(G17DT) Durham, NC (see also colorectal, pancreatic) www.canceradvancesinc.com
Orphan Drug
Other Cancers
Product Name Sponsor Indication Development Phase
CPP-1X/sulindac Cancer Prevention Pharmaceuticals colorectal cancer (risk reduction) Phase III
(eflornithine/sulindac) Tucson, AZ (see also other) www.canprevent.com
Other Cancers
Product Name Sponsor Indication Development Phase
HPV-16 E6 TCR Kite Pharma HPV-associated cancers (vaginal, cervical, anal, Phase I/II
(T-cell receptor antigen antagonist) Santa Monica, CA penile, or oropharyngeal cancers) www.kitepharma.com
National Cancer Institute
Bethesda, MD
INO-3112 Inovio Pharmaceuticals cervical cancer caused by HPV types 16 and 18 Phase I/II
(cancer immunotherapy) Plymouth Meeting, PA www.inovio.com
pasireotide long acting release Novartis Pharmaceuticals neuroendocrine tumors, pituitary cancer Phase II
(SOM230) East Hanover, NJ (see also prostate, skin) www.novartis.com
rucaparib Clovis Oncology fallopian tube cancer, peritoneal cancer Phase III
(PARP inhibitor) Boulder, CO (see also breast, ovarian, pancreatic) www.clovisoncology.com
telotristat etiprate Lexicon Pharmaceuticals malignant carcinoid syndrome (Fast Track) Phase III
(TPH1 inhibitor) The Woodlands, TX www.lexicon-genetics.com
Orphan Drug
Other Cancers
Product Name Sponsor Indication Development Phase
Definitions
Application SubmittedAn application for marketing has been submitted by the company to the U.S. Food and Drug Administration (FDA).
Fast TrackUpon request by a sponsor, the FDA can grant this designation to facilitate the development and expedite the review of a drug or biologic to treat a serious condition and fill an
unmet medical need. When considering a biopharmaceutical companys request for Fast Track designation for an investigational drug or biologic, the FDA evaluates whether it will affect
factors such as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one, and whether a condition
can be adequately addressed by available therapy. With Fast Track designation, early and frequent communication between the FDA and the biopharmaceutical company is encouraged
throughout the entire drug development and review process to help to quickly resolve and questions or issues that arise, potentially leading to an earlier approval and access by patients.
Orphan DesignationUpon request by a sponsor, the FDA can grant special status (orphan status) to a drug or biologic to treat a rare disease or disease or condition. In order to
receive an orphan designation, a qualifying drug or biologic must be intended for the treatment, diagnosis, or prevention of a rare disease or condition that affects fewer than 200,000
people in the United States, or that affects more than 200,000 persons but is not expected to recover the costs of its development and marketing.
Phase IResearchers test the investigational drug or biologic in a small group of people, usually between 20 and 100 healthy adult volunteers, to evaluate its initial safety and
tolerability profile, determine a safe dosage range, and identify potential side effects.
Phase IIThe investigational drug or biologic is given to volunteer patients, usually between 100 and 500, to determine whether it is effective, identify an optimal dose, and to further
evaluate its short-term safety.
Phase IIIThe investigational drug or biologic is given to a larger, more diverse patient population, often involving between 1,000 and 5,000 patients ( but sometimes many more),
to generate statistically significant evidence to confirm its safety and effectiveness. Phase III studies are the longest studies and usually take place in multiple sites around the world.
The content of this report has been obtained through public, government and industry sources, and the Adis R&D Insight database based on the latest information. Report current as of
August 21, 2015. The medicines in this listing include medicines being developed by U.S.-based companies conducting trials in the United States and abroad, PhRMA-member companies conducting
trials in the United States and abroad, and foreign companies conducting clinical trials in the United States. The information may not be comprehensive. For more specific information about a
particular product, contact the individual company directly or go to www.clinicaltrials.gov. The entire series of Medicines in Development is available on PhRMA's website at www.phrma.org.