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Fast track drug sets TGA record
Posted 2 February 2018
Roche's Alecensa has set a new benchmark for regulatory review after the first ever priority designated drug sped through the TGA in under five months.
The evaluation to extend the drug's lung cancer indication commenced on 7 September 2017 and finished at the end of January, according to the TGA website.
The total amount of days taken to evaluate the drug came in at 145 overall, or around 103 working days, although the actual figure may be less since the evaluation went over the Christmas/New Year holiday period.
This timeframe cuts the usual 255 working days taken by the TGA for assessment to less than half. It also comes well under the 150 working days nominated as a "target timeframe" by the regulator for priority reviews, although the fact the submission was for an extended usage, rather than a new drug, may have affected the length of its evaluation.
Alecensa is now indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer, bringing the therapy into a first-line setting for the condition.
Though quick, the TGA review nonetheless appears to have been playing catch up with the PBAC recommendation of the drug for the same indication, which was handed down last July.
With nine drugs now designated under the new fast track pathway, more are expected to be registered in the coming year with Roche's Helimbra, extensions for BMS' Opdivo and AZ's Tagrisso next in line according to date of designation.
Yajun Ma
Posted 2 February 2018
Roche's Alecensa has set a new benchmark for regulatory review after the first ever priority designated drug sped through the TGA in under five months.
The evaluation to extend the drug's lung cancer indication commenced on 7 September 2017 and finished at the end of January, according to the TGA website.
The total amount of days taken to evaluate the drug came in at 145 overall, or around 103 working days, although the actual figure may be less since the evaluation went over the Christmas/New Year holiday period.
This timeframe cuts the usual 255 working days taken by the TGA for assessment to less than half. It also comes well under the 150 working days nominated as a "target timeframe" by the regulator for priority reviews, although the fact the submission was for an extended usage, rather than a new drug, may have affected the length of its evaluation.
Alecensa is now indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer, bringing the therapy into a first-line setting for the condition.
Though quick, the TGA review nonetheless appears to have been playing catch up with the PBAC recommendation of the drug for the same indication, which was handed down last July.
With nine drugs now designated under the new fast track pathway, more are expected to be registered in the coming year with Roche's Helimbra, extensions for BMS' Opdivo and AZ's Tagrisso next in line according to date of designation.
Yajun Ma
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