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Lilly's US approved cancer drug tipped for Aust
Posted 3 October 2017
Lilly has won FDA approval for its highly anticipated breast cancer drug Verzenio (abemaciclib) with strong expectations the company will file the drug with the TGA for Australian approval and seek PBS reimbursement.
FDA approved in combination with AstraZeneca's Faslodex (fulvestrant) for advanced or metastatic HR-positive, HER2-negative breast cancer following endocrine therapy, the approval is a strong boost to the company's oncology portfolio hopes and makes Verzenio a strong contender for Australian approval.
The drug is part of a maturing class of therapies called cyclin-dependent kinase (CDK) 4/6 inhibitors that includes Pfizer's Ibrance (palbociclib) and Novartis' Kisqali (ribociclib).
Ibrance won TGA approval in May but was rejected for reimbursement by the PBAC in March. Kisqali met a similar fate at the PBAC's July meeting and the two inhibitors will now both go before the PBAC for reconsideration in November.
If Lilly is successful in gaining approval and reimbursement for Verzenio, it will compete with the other inhibitors which will have a head start should they meet with success at the PBAC meeting next month.
Recently appointed Lilly Australia and New Zealand General Manager Libby Driscoll told Pharma in Focus last month she intended to launch 20 products locally including "some later stage drugs coming in oncology".
Lilly recently touted Verzenio as best-in-class following a positive readout from late-stage data evaluating a combination of Verzenio and an aromatase inhibitor against placebo and an aromatase inhibitor in HR-positive, HER2-negative breast cancer patients.
Those in the experimental group ultimately showed significant improvement in progression-free survival - results the company hopes bolster a future approval in the first-line setting.
"Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy," the FDA's Richard Pazdur said.
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 3 October 2017
Lilly has won FDA approval for its highly anticipated breast cancer drug Verzenio (abemaciclib) with strong expectations the company will file the drug with the TGA for Australian approval and seek PBS reimbursement.
FDA approved in combination with AstraZeneca's Faslodex (fulvestrant) for advanced or metastatic HR-positive, HER2-negative breast cancer following endocrine therapy, the approval is a strong boost to the company's oncology portfolio hopes and makes Verzenio a strong contender for Australian approval.
The drug is part of a maturing class of therapies called cyclin-dependent kinase (CDK) 4/6 inhibitors that includes Pfizer's Ibrance (palbociclib) and Novartis' Kisqali (ribociclib).
Ibrance won TGA approval in May but was rejected for reimbursement by the PBAC in March. Kisqali met a similar fate at the PBAC's July meeting and the two inhibitors will now both go before the PBAC for reconsideration in November.
If Lilly is successful in gaining approval and reimbursement for Verzenio, it will compete with the other inhibitors which will have a head start should they meet with success at the PBAC meeting next month.
Recently appointed Lilly Australia and New Zealand General Manager Libby Driscoll told Pharma in Focus last month she intended to launch 20 products locally including "some later stage drugs coming in oncology".
Lilly recently touted Verzenio as best-in-class following a positive readout from late-stage data evaluating a combination of Verzenio and an aromatase inhibitor against placebo and an aromatase inhibitor in HR-positive, HER2-negative breast cancer patients.
Those in the experimental group ultimately showed significant improvement in progression-free survival - results the company hopes bolster a future approval in the first-line setting.
"Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy," the FDA's Richard Pazdur said.
Megan Brodie
megan.brodie@lushmedia.com.au
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