Products

Date: 2017-06-08

Type of information: Granting of the orphan status in the US

Product name: ADCT-402

Compound: humanized monoclonal immunoglobulin G1 antibody directed against human CD19 conjugated to SG3199 through a protease cleavable valine-alanine linker

Therapeutic area: Cancer - Oncology - Rare diseases

Action mechanism: antibody drug conjugate. ADCT-402 is a novel antibody-drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated to ADCT's highly potent proprietary pyrrolobenzodiazepine (PBD) dimer toxin.

Company: ADC Therapeutics (Switzerland)

Disease: mantle cell lymphoma

Latest news:

• • On June 8, 2017, the FDA has granted Orphan Drug Designation to ADCT-402, a humanized monoclonal immunoglobulin G1 antibody directed against human CD19 conjugated to SG3199 through a protease cleavable valine-alanine linker,  for the treatment of mantle cell lymphoma. ADCT-402 is being evaluated in two ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory B-cell lineage non-Hodgkin lymphoma and relapsed or refractory B-cell lineage acute lymphoblastic leukemia.

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: 2017-06-08

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes