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AZ launches PAP on Lynparza approval
Posted 16 March 2016
As it awaits the outcome of last week's PBAC meeting, AstraZeneca has welcomed TGA approval of Lynparza (olaparib) for ovarian, fallopian tube or primary peritoneal cancer and launched a patient access program.
The PBAC last week considered a major submission for reimbursement of the drug as an Authority Required (streamlined) listing for the treatment of platinum-sensitive relapsed ovarian, fallopian tube or primary peritoneal cancer with high-grade serous features or a high grade serous component.
"Lynparza - a PARP Inhibitor - is the first TGA approved targeted oral treatment option for women with BRCA mutated, platinum-sensitive, relapsed ovarian cancer (HGSOC)," AZ said, noting that currently, once surgery and appropriate chemotherapy options have been exhausted, "there has been little else for these women to turn to".
Following TGA registration, AZ launched a patient access program for women with BRCA1/2 mutation positive ovarian cancer (HGSOC) who have been prescribed Lynparza by their medical oncologist.
It said the enrollment period for new patients would last for 12 months.
It has also launched a nationally available pre-test genetic counselling and BRCA testing service for all women diagnosed with HGSOC who have not already had their BRCA1/2 status assessed.
Paul Spittle, country president, Australia & New Zealand said: "As we await the outcome of the Pharmaceutical Benefits Advisory Committee review to determine listing on the Pharmaceutical Benefits Scheme, AstraZeneca will be operating a national BRCA testing initiative and Patient Access Program.
"In doing so, AstraZeneca is also working with the Medical Services Advisory Committee to have BRCA testing approved to determine eligibility for Lynparza."
Nick Lush
nick.lush@lushmedia.com.au
Posted 16 March 2016
As it awaits the outcome of last week's PBAC meeting, AstraZeneca has welcomed TGA approval of Lynparza (olaparib) for ovarian, fallopian tube or primary peritoneal cancer and launched a patient access program.
The PBAC last week considered a major submission for reimbursement of the drug as an Authority Required (streamlined) listing for the treatment of platinum-sensitive relapsed ovarian, fallopian tube or primary peritoneal cancer with high-grade serous features or a high grade serous component.
"Lynparza - a PARP Inhibitor - is the first TGA approved targeted oral treatment option for women with BRCA mutated, platinum-sensitive, relapsed ovarian cancer (HGSOC)," AZ said, noting that currently, once surgery and appropriate chemotherapy options have been exhausted, "there has been little else for these women to turn to".
Following TGA registration, AZ launched a patient access program for women with BRCA1/2 mutation positive ovarian cancer (HGSOC) who have been prescribed Lynparza by their medical oncologist.
It said the enrollment period for new patients would last for 12 months.
It has also launched a nationally available pre-test genetic counselling and BRCA testing service for all women diagnosed with HGSOC who have not already had their BRCA1/2 status assessed.
Paul Spittle, country president, Australia & New Zealand said: "As we await the outcome of the Pharmaceutical Benefits Advisory Committee review to determine listing on the Pharmaceutical Benefits Scheme, AstraZeneca will be operating a national BRCA testing initiative and Patient Access Program.
"In doing so, AstraZeneca is also working with the Medical Services Advisory Committee to have BRCA testing approved to determine eligibility for Lynparza."
Nick Lush
nick.lush@lushmedia.com.au
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