Australia's most trusted source of pharma news
AZ hunting breast approval for Lynparza
Posted 16 January 2017
AstraZeneca "will be working with all stakeholders to obtain the earliest possible access for patients" to Lynparza (olaparib) as a breast cancer drug in Australia.
Lynparza recently won FDA approval for treatment of germline BRCA-mutated metastatic breast cancer, making it the first PARP inhibitor to be approved for use beyond an ovarian cancer setting.
In Australia it is PBS-listed as an ovarian, fallopian tube or peritoneal cancer maintenance therapy for patients with germline BRCA gene mutations.
A spokesperson for the company confirmed it would be making plans for an extension of the drug's local usage to breast cancer. It did not disclose exact details of potential registration or reimbursement dates.
The drug's FDA approval was completed in only three months after it received a priority review designation, with approval based on a phase 3 trial showing Lynparza established an objective response rate of 52 per cent in patients with measurable disease, compared to half that rate for chemotherapy.
Though first to make it to market, Lynparza is not the only PARP inhibitor lined up for breast cancer use as Clovis' Rubraca (rucaparib) and Tesaro's Zejula (niraparib) are currently in clinical trials for the indication as well. Neither of these PARP inhibitors however have been registered on the ARTG though Tesaro has stated it is weighing up options for an ovarian filing.
Lynparza was PBAC positively recommended in November 2016 and was listed four months later, with the committee recommending the listing based on cost-effectiveness, stating the drug provided "a significant improvement in efficacy over best supportive care".
An additional breast cancer indication is not the only expansion AZ has set its sights either as the PBAC's March agenda revealed the company is gunning for first-line reimbursement in ovarian cancer.
Yajun Ma
yajun.ma@lushmedia.com.au
Posted 16 January 2017
AstraZeneca "will be working with all stakeholders to obtain the earliest possible access for patients" to Lynparza (olaparib) as a breast cancer drug in Australia.
Lynparza recently won FDA approval for treatment of germline BRCA-mutated metastatic breast cancer, making it the first PARP inhibitor to be approved for use beyond an ovarian cancer setting.
In Australia it is PBS-listed as an ovarian, fallopian tube or peritoneal cancer maintenance therapy for patients with germline BRCA gene mutations.
A spokesperson for the company confirmed it would be making plans for an extension of the drug's local usage to breast cancer. It did not disclose exact details of potential registration or reimbursement dates.
The drug's FDA approval was completed in only three months after it received a priority review designation, with approval based on a phase 3 trial showing Lynparza established an objective response rate of 52 per cent in patients with measurable disease, compared to half that rate for chemotherapy.
Though first to make it to market, Lynparza is not the only PARP inhibitor lined up for breast cancer use as Clovis' Rubraca (rucaparib) and Tesaro's Zejula (niraparib) are currently in clinical trials for the indication as well. Neither of these PARP inhibitors however have been registered on the ARTG though Tesaro has stated it is weighing up options for an ovarian filing.
Lynparza was PBAC positively recommended in November 2016 and was listed four months later, with the committee recommending the listing based on cost-effectiveness, stating the drug provided "a significant improvement in efficacy over best supportive care".
An additional breast cancer indication is not the only expansion AZ has set its sights either as the PBAC's March agenda revealed the company is gunning for first-line reimbursement in ovarian cancer.
Yajun Ma
yajun.ma@lushmedia.com.au
Drought, fire and now virus cut chance of PBS relief.
Don't do it for the accolades; do it for your kids.
New forms of rotavirus vaccine Rotarix.