Date: 2016-12-12
Type of information: Granting of the orphan status in the EU
Product name: avelumab
Compound: recombinant human monoclonal IgG1 antibody against programmed death ligand-1 (anti-PD-L1)
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism: monoclonal antibody/immune checkpoint inhibitor. MSB0010718C (avelumab) is a fully human IgG1 monoclonal antibody that binds to the PD-L1 (programmed death-ligand 1) protein, which is present at high levels in many cancer types. By competitively blocking the interaction with PD-1 receptors, it is believed that MSB0010718C thereby restores anti-tumor T-cell responses and inhibits tumor growth. The clinical development program for avelumab, known as JAVELIN, involves at least 30 clinical programs and over 2,900 patients evaluated across more than 15 different tumor types. In addition to metastatic MCC, these cancers include breast, gastric/gastro-esophageal junction, head and neck, Hodgkin's lymphoma, melanoma, mesothelioma, non-small cell lung, ovarian, renal cell carcinoma and urothelial (primarily bladder).
Company: Merck Serono (Germany)
Disease: gastric cancer
Latest news: * On 3-4 November 2016, the Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending the approval of the orphan medicinal product designation for avelumab for treatment of gastric cancer.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE: 2016-12-12
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
