Overview compounds Audited

Oncology

Erbitux® (cetuximab, monoclonal anti-EGFR antibody)¹

Adjuvant colorectal cancer

Phase III

Gastric cancer

Phase III

Cilengitide (integrin inhibitor)

Glioblastoma (brain tumor)

Phase III

Stimuvax® (therapeutic cancer vaccine)²

Non-small-cell lung cancer (NSCLC)

Phase III

Breast cancer

Phase III

Erbitux®¹

Breast cancer

Phase II

Tucotuzumab celmoleukin (immunocytokine)

Small-cell lung cancer (SCLC)

Phase II

Cilengitide

Head and neck cancer (SCCHN)

Phase II

Non-small-cell lung cancer (NSCLC)

Phase II

Adecatumumab (monoclonal anti-EpCAM antibody)³

Colorectal cancer

Phase II

Monoclonal anti-integrin antibody (DI17E6)

Colorectal cancer

Phase II

TLR9 immunomodulator
(IMO-2055)⁴

Head and neck cancer (SCCHN)

Phase II

Aurorakinase inhibitor
(AS703569)⁵

Solid tumors and hematological diseases

Phase I

MEK inhibitor (AS703026)⁶

Solid tumors and hematological diseases

Phase I

Sonepcizumab (monoclonal anti-S1P antibody)⁷

Solid tumors

Phase I

c-Met kinase inhibitor (EMD1214063)⁸

Solid tumors

Phase I

Neurodegenerative Diseases

New formulation of Rebif®

Relapsing-remitting forms
of multiple sclerosis (MS);
EMA: approved, FDA: filed

Approved/
Filed

Clinically isolated syndrome

Phase III

Cladribine tablets

Relapsing-remitting forms of MS;
EMA: filed, FDA: resubmission in preparation

Filed

Clinically isolated syndrome

Phase III

Safinamide⁹

Early-stage Parkinson’s disease

Phase III

Mid- to late-stage Parkinson’s disease

Phase III

Autoimmune & Inflammatory Diseases

Atacicept (anti-BLyS/anti-APRIL fusion protein)¹⁰

Systemic lupus erythematosus

Phase III

Fibroblast growth factor 18¹⁰

Osteoarthritis

Phase I

Endocrinology

Tesamorelin¹¹

Lipodystrophy in HIV patients (only U.S.)

Filed

ARX 201
(long-acting growth hormone)¹²

Growth hormone deficiency

Phase II