Innlegg av: blande (19.08.14 21:47 ), lest 11339 ganger
Ticker: NANO
RE^1: Nordic Nanovector - en 30-doblingskandidat
Da ser det ut som det offentlige referatet fra EMA møtet er ute, og Jan Alfheim (daglig leder i NANO) hadde dekning for å si at de hadde et bra møte i Europa. Det er vel da overveiende sannsynlig at vi allerede nå kan huke av for vellykket fase I/IIa.
Committee for Orphan Medicinal Products (COMP)Minutes of the 8-9 April 2014 meeting:
2.1.3 177Lu-tetraxetan-tetulomab for treatment of follicular lymphoma, Nordic Nanovector AS -
EMA/OD/200/13
[Co-ordinators: F. Naumann-Winter]
As agreed during the previous meeting, a list of issues was sent to the sponsor for response. The
sponsor was asked to clarify the following issues:
•Medical plausibility
In order to establish the medical plausibility the sponsor is invited to clarify the relevance of the cell
lines used in the generation of the in vitro and in vivo preclinical data to the proposed condition
follicular lymphoma.
In addition the sponsor was asked to provide the results of the rituximab group in the preclinical
xenograft study and to comment on the survival curve of the control group.
•Significant benefit
In order to support the significant benefit, the sponsor was asked to provide more details on the
preliminary clinical data, including the baseline parameters of the five patients with follicular
lymphoma, the time since last treatment, the number of betalutin doses given, and the concomitant
treatments.
The sponsor was also invited to further discuss the response criteria applied for evaluating treatment
success in these patients.
In the written response, and during an oral explanation before the Committee on 8 April 2014, the
sponsor further elaborated on the available preliminary clinical data from a dose-finding study with
overall seven patients affected by follicular lymphoma who have been treated with the product and of
whom five were evaluated for response. The sponsor explained that patients have received pre-
treatment with rituximab and the unlabelled anti-CD37 tetulomab before the administration of the
product. The sponsor presented PET images from two patients showing objective responses with
regards to reduction of the tumour size at three months. The COMP considered that convincing
preliminary evidence of the efficacy of the product in addition to the currently authorized treatments
for follicular lymphoma exist. The Committee agreed that the condition, follicular lymphoma is a
distinct medical entity and meets the criteria for orphan designation.
The intention to treat the condition with the medicinal product containing 177Lu-tetraxetan-tetulomab
was considered justified based on preclinical and on preliminary clinical data showing antitumor
activity.
The condition is life-threatening and chronically debilitating due to lymphadenopathy, splenomegaly,
bone marrow dysfunction and the potential of transformation to aggressive lymphoma.
The condition was estimated to be affecting less than 3.7 in 10,000 persons in the European Union, at
the time the application was made.
In addition, although satisfactory methods of treatment of the condition have been authorised in the
European Union, the sponsor has provided sufficient justification for the assumption that the medicinal
product containing 177Lu-tetraxetan-tetulomab may be of significant benefit to those affected by the
condition. The sponsor provided preliminary clinical data showing favourable response in relapsed
patients when the product was used in combination with rituximab. The Committee considered that
this constitutes a clinically relevant advantage for the patients affected by follicular lymphoma.
A positive opinion for 177Lu-tetraxetan-tetulomab, for treatment of follicular lymphoma, was adopted
by consensus