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Six drugs on TGA priority review path
Posted 7 December 2017
Traffic on the TGA's new Priority Review pathway is increasing with three more drugs being assessed for faster access to the ARTG.
With the pathway open for just five months, BMS' Opdivo (nivolumab) is now being assessed for two indications - stage III/IV melanoma and in combination with Yervoy (ipilimumab) for advanced renal cell carcinoma (RCC).
Opdivo was joined on the new pathway this month by AstraZeneca's Tagrisso (osimertinib), hunting down a faster ARTG registration in first-line advanced or metastatic non-small cell lung cancer (NSCLC) for people whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
Also jumping on the new pathway was BioMarin with Brineura (cerliponase alfa) which is looking for ARTG registration in neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.
BioMarin won approval in the US for the same indication in April and Europe in May. Successfully navigating the Priority Review pathway could see Brineura on the ARTG by May 2018.
Roche was the first company to take advantage of the new pathway, registering Hemlibra (emicizumab) and Alecensa (alectinib) in August and is therefore expected to have the first product to successfully reach the ARTG through Priority Review.
The TGA's assistant secretary of its Prescription Medicines Authorisation Branch told a Sydney conference in October the new pathway was "a real success story" with the first three medicines having "substantial merit".
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 7 December 2017
Traffic on the TGA's new Priority Review pathway is increasing with three more drugs being assessed for faster access to the ARTG.
With the pathway open for just five months, BMS' Opdivo (nivolumab) is now being assessed for two indications - stage III/IV melanoma and in combination with Yervoy (ipilimumab) for advanced renal cell carcinoma (RCC).
Opdivo was joined on the new pathway this month by AstraZeneca's Tagrisso (osimertinib), hunting down a faster ARTG registration in first-line advanced or metastatic non-small cell lung cancer (NSCLC) for people whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
Also jumping on the new pathway was BioMarin with Brineura (cerliponase alfa) which is looking for ARTG registration in neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.
BioMarin won approval in the US for the same indication in April and Europe in May. Successfully navigating the Priority Review pathway could see Brineura on the ARTG by May 2018.
Roche was the first company to take advantage of the new pathway, registering Hemlibra (emicizumab) and Alecensa (alectinib) in August and is therefore expected to have the first product to successfully reach the ARTG through Priority Review.
The TGA's assistant secretary of its Prescription Medicines Authorisation Branch told a Sydney conference in October the new pathway was "a real success story" with the first three medicines having "substantial merit".
Megan Brodie
megan.brodie@lushmedia.com.au
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