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Pfizer jumps on fast track
Posted 3 October 2018
Two more companies have jumped on the TGA's provisional track with Pfizer and Celgene receiving designations for cancer and blood drugs respectively.
Pfizer's lung cancer drug lorlatinib and Celgene's leukaemia therapy Idhifa have both been granted the designations, meaning the drugs could be approved conditionally two years ahead of time if accepted for filing.
Both companies are first time users of the pathway. Lilly was the first to win a provisional designation with olaratumab and MSD received two tags for checkpoint inhibitor Keytruda.
The TGA does not publish indications for drugs which have received provisional designations, however Pfizer's lorlatinib was filed in the US and EU for treatment of ALK-positive non-small cell lung cancer in February.
Meanwhile Celgene's Idhifa has received orphan drug designation in Australia for treatment of patients for acute myeloid leukaemia with an isocitrate dehydrogenase-2 mutation.
The regulator was also busy last week adding another medicine to the priority review fast track, which recently celebrated a year since implementation.
AZ's Lynparza received the fast track tag as a maintenance treatment for newly diagnosed BBRCA-mutated advanced ovarian cancer after the company indicated earlier in the year it would file the drug locally.
The PARP inhibitor is fast expanding its hold as the only medicine of its class to be approved in Australia after it was PBS listed for second-line ovarian treatment in February.
Roche's Tecentriq also received an orphan drug designation in the same week for treatment of small cell lung cancer.
The checkpoint inhibitor appears to be building on its April PBS listing for metastatic NSCLC patients.
Orphan designations, like both fast track tags, expire six months after being granted. All four of the new designations granted last week will end in March 2019.
Yajun Ma
Posted 3 October 2018
Two more companies have jumped on the TGA's provisional track with Pfizer and Celgene receiving designations for cancer and blood drugs respectively.
Pfizer's lung cancer drug lorlatinib and Celgene's leukaemia therapy Idhifa have both been granted the designations, meaning the drugs could be approved conditionally two years ahead of time if accepted for filing.
Both companies are first time users of the pathway. Lilly was the first to win a provisional designation with olaratumab and MSD received two tags for checkpoint inhibitor Keytruda.
The TGA does not publish indications for drugs which have received provisional designations, however Pfizer's lorlatinib was filed in the US and EU for treatment of ALK-positive non-small cell lung cancer in February.
Meanwhile Celgene's Idhifa has received orphan drug designation in Australia for treatment of patients for acute myeloid leukaemia with an isocitrate dehydrogenase-2 mutation.
The regulator was also busy last week adding another medicine to the priority review fast track, which recently celebrated a year since implementation.
AZ's Lynparza received the fast track tag as a maintenance treatment for newly diagnosed BBRCA-mutated advanced ovarian cancer after the company indicated earlier in the year it would file the drug locally.
The PARP inhibitor is fast expanding its hold as the only medicine of its class to be approved in Australia after it was PBS listed for second-line ovarian treatment in February.
Roche's Tecentriq also received an orphan drug designation in the same week for treatment of small cell lung cancer.
The checkpoint inhibitor appears to be building on its April PBS listing for metastatic NSCLC patients.
Orphan designations, like both fast track tags, expire six months after being granted. All four of the new designations granted last week will end in March 2019.
Yajun Ma
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