dm+d

Unassigned

New Medicines

MinjuviRelapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) who are not eligible for autologous stem cell transplant (ASCT), in combination with lenalidomide

Information

Minjuvi
New molecular entity
Incyte
MorphoSys

Development and Regulatory status

Phase II Clinical Trials
Recommended for approval (Positive opinion)
Approved (Licensed)
Jun 21Recommended for conditional EU approval by CHMP – the full indication is “Minjuvi is indicated in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). Minjuvi will be available as a powder for concentrate for solution for infusion (200mg) [8].
Aug 20Approved in US in combination with lenalidomide for or treatment of adults with relapsed or refractory DLBCL [6].
May 20Filed in EU via centralised procedure [5].
Jan 20MorphoSys have partnered with Incyte who will market tafasitamab outside of the USA. [4]
Jan 20MorphoSys has submitted a Biologics License Application to the U.S. FDA for tafasitamab, an anti-CD19 antibody, for the treatment of relapsed or refractory diffuse large B cell lymphoma [1].

Category

Humanized Fc-engineered monoclonal antibody directed against CD19
The overall annual incidence of diffuse large B cell lymphoma in Europe is 3.8/100,000 but the incidence increases with age and varies considerably across Europe [2].
Relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) who are not eligible for autologous stem cell transplant (ASCT), in combination with lenalidomide
Intravenous

Further information

Yes
August 2022

Trial or other data

Mar 20PII/III B-MIND study (NCT02763319) will assess progression free survival, objective response rate (ORR), duration of response (DoR), overall survival (OS), disease control rate (DCR), time to progression (TTP) as well as an evaluation of patients quality of life (QoL). It is recruiting 450 adults in countries including the UK, Europe and US. It is due to complete collection of primary outcome data in Mar 22 [7].
Jan 20PIII ongoing study B-MIND assesses the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL [1].
Jan 20PII trial NCT04150328 is investigating efficacy of tafasitinib plus lenalidomide in R/R DLBCL compared with lenatidomide alone [3].

Evidence based evaluations