Die Chancen für TLX-250 CD sind ungleich besser. Erst kürzlich hat die FDA den Sonderstatus Breakthrough Therapy Designation vergeben. Vorsicht ist immer gut. Doch sich schlau machen, hilft das Ganze dann doch einzuordnen.
Quelle:
https://telixpharma.com/investors/#asxTelix Granted FDA Breakthrough Therapy Designation
for Renal Cancer Imaging Product
Melbourne (Australia) – 1st July 2020. Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the
‘Company’) today announces that the US Food and Drug Administration (FDA) has granted
Breakthrough Therapy (BT) designation for Telix’s renal cancer imaging product TLX250-CDx (
89Zrgirentuximab). Under BT status, the FDA will work closely with Telix to provide guidance to the
Company on the development of TLX250-CDx for the diagnosis of “indeterminate renal masses” that
have been identified on CT or MRI imaging. TLX250-CDx is being developed for the purpose of
determining whether such “indeterminate renal masses” are either clear cell renal cell cancer
(ccRCC) or non-ccRCC, using Positron Emission Tomography (PET) imaging.
BT designation offers a number of significant benefits to Telix, including eligibility for Fast Track
designation, more frequent and intensive interactions with the FDA, and the opportunity to submit a
“rolling” Biological Licence Application (BLA) for TLX250-CDx, where the application can be
submitted in separate modules to streamline the FDA review process for approval. The criteria for
BT designation require preliminary clinical evidence that demonstrates the product may have
substantial improvement on at least one clinically significant endpoint over available care.
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