Posted by Michael Wonder on 28 Apr 2016
PBAC to consider first submission for a cellular therapy in July
28 April 2016 - The PBAC will consider a major submission from Amgen for talimogene laherparepvec (Imlygic) at its next scheduled meeting in July.
Talimogene laherparepvec is an oncolytic virus therapy. It’s a genetically modified herpes virus that is thought to work by multiplying inside the cancer cells and killing them, as well as by alerting the immune system to attack the cancer cells.
Imlygic was approved by the TGA on 21 December 2015 for use as monotherapy for the treatment of melanoma in patients with unresectable cutaneous, subcutaneous or nodal lesions after initial surgery.
Amgen is seeking an Authority Required PBS listing for Imlygic for use in patients with unresectable Stage III or Stage IV melanoma without visceral metastases.
For more details, go to: http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/agenda/pdf/pbac-meeting-agenda-july-2016.pdf
