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TGA fast track playing catch up with PBAC
Posted 7 November 2017
Roche's lung cancer drug Alecensa (alectinib) - the first drug to be granted a priority review under the TGA's new ARTG fast track - has already been approved for PBS listing in the same indication leaving Roche to negotiate with the TGA to catch up with the PBAC.
Roche confirmed to Pharma in Focus it is currently negotiating both for the PBS listing of Alecensa following a positive recommendation by the PBAC in July while also seeking to extend its ARTG registration to cover the first-line use of the drug in ALK-positive non small cell lung cancer (NSCLC) patients.
Alecensa is currently registered on the ARTG for ALK-positive NSCLC following Pfizer's Xalkori (crizotinib).
Alecensa is the first drug to be approved for priority review in Australia and Roche confirmed it had filed the drug for approval with the TGA, which has 150 working days to make a decision under the new approval pathway.
Alecensa won approval in the US this week as a first-line option in ALK-positive NSCLC.The FDA approved Alecensa as initial treatment for patients with the rare form of non-small cell lung cancer caused by a mutation to the ALK gene.
The latest approval extends Roche's market to all ALK-positive NSCLC patients - around five per cent of NSCLC patients.
Approved for priority review in August for the first-line setting, if filed immediately Alecensa could be ARTG-registered for first-line use by April 2018.
However, if PBS listed before that time, it could be prescribed off-label and subsidised on the PBS despite not being registered on the ARTG for first-line use creating an unusual scenario where the TGA is playing catch-up with the PBAC.
Meanwhile, the FDA also approved Roche's melanoma drug Zelboraf (vemurafenib) for Erdheim-Chester Disease with the BRAF V600 mutation. It is the first FDA-approved treatment for the disease.
Zelboraf was PBS listed in September for melanoma patients with the BRAF V600 mutation-positive metastatic melanoma.
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 7 November 2017
Roche's lung cancer drug Alecensa (alectinib) - the first drug to be granted a priority review under the TGA's new ARTG fast track - has already been approved for PBS listing in the same indication leaving Roche to negotiate with the TGA to catch up with the PBAC.
Roche confirmed to Pharma in Focus it is currently negotiating both for the PBS listing of Alecensa following a positive recommendation by the PBAC in July while also seeking to extend its ARTG registration to cover the first-line use of the drug in ALK-positive non small cell lung cancer (NSCLC) patients.
Alecensa is currently registered on the ARTG for ALK-positive NSCLC following Pfizer's Xalkori (crizotinib).
Alecensa is the first drug to be approved for priority review in Australia and Roche confirmed it had filed the drug for approval with the TGA, which has 150 working days to make a decision under the new approval pathway.
Alecensa won approval in the US this week as a first-line option in ALK-positive NSCLC.The FDA approved Alecensa as initial treatment for patients with the rare form of non-small cell lung cancer caused by a mutation to the ALK gene.
The latest approval extends Roche's market to all ALK-positive NSCLC patients - around five per cent of NSCLC patients.
Approved for priority review in August for the first-line setting, if filed immediately Alecensa could be ARTG-registered for first-line use by April 2018.
However, if PBS listed before that time, it could be prescribed off-label and subsidised on the PBS despite not being registered on the ARTG for first-line use creating an unusual scenario where the TGA is playing catch-up with the PBAC.
Meanwhile, the FDA also approved Roche's melanoma drug Zelboraf (vemurafenib) for Erdheim-Chester Disease with the BRAF V600 mutation. It is the first FDA-approved treatment for the disease.
Zelboraf was PBS listed in September for melanoma patients with the BRAF V600 mutation-positive metastatic melanoma.
Megan Brodie
megan.brodie@lushmedia.com.au
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