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Posted 4 May 2017
AstraZeneca has finally got off the blocks in the PD-L1 immunotherapy race, notching up its first global approval for Imfinzi (durvalumab) in bladder cancer - with plans for an Australian approval to follow.
The FDA gave the green light to Imfinzi in the US on Monday, approving it for locally advanced or metastatic urothelial carcinoma six weeks ahead of schedule based on phase I/II data.
The swift approval is already being celebrated by AstraZeneca Australia, with plans to file locally.
"In Australia, we will be working with all stakeholders to obtain the earliest possible access for patients," a spokesperson said.
Although bladder cancer is a relatively small initial market and the second-line setting for Imfinzi restricts its reach even more, it does allow AstraZeneca to finally get traction in the fiercely contested checkpoint inhibitors race.
BMS' Opdivo (nivolumab) and MSD's Keytruda (pembrolizumab) are leading, each notching up multiple approvals to date, although Roche's Tecentriq (atezolizumab) is a strong contender and the first to score a bladder cancer win. Roche extended this with first-line approval from the FDA last month and Tecentriq is also approved in non-small cell lung cancer, both indications for which Roche has filed in Australia.
Merck KGaA/Pfizer are also off the blocks with Bavencio (avelumab), which has a single FDA tick in metastatic merkel cell carcinoma.
Despite being the fifth checkpoint inhibitor to win an approval, Imfinzi is expected to be a blockbuster for the company. AstraZeneca in 2014 put the drug's potential peak sales in all cancers at US$6.5 billion, including combination use.
"Imfinzi is the cornerstone of our extensive immuno-oncology program, in development across many tumour types, as monotherapy and in combination," said AstraZeneca CEO Pascal Soriot. "This first approval for Imfinzi is an important milestone in our return to growth."
AstraZeneca recognises the drug needs first-line approvals if it is to compete and has key clinical trial results for it as a monotherapy and combination therapy in lung cancer due mid-year.
Megan Brodie
Megan.brodie@lushmedia.com.au
Posted 4 May 2017
AstraZeneca has finally got off the blocks in the PD-L1 immunotherapy race, notching up its first global approval for Imfinzi (durvalumab) in bladder cancer - with plans for an Australian approval to follow.
The FDA gave the green light to Imfinzi in the US on Monday, approving it for locally advanced or metastatic urothelial carcinoma six weeks ahead of schedule based on phase I/II data.
The swift approval is already being celebrated by AstraZeneca Australia, with plans to file locally.
"In Australia, we will be working with all stakeholders to obtain the earliest possible access for patients," a spokesperson said.
Although bladder cancer is a relatively small initial market and the second-line setting for Imfinzi restricts its reach even more, it does allow AstraZeneca to finally get traction in the fiercely contested checkpoint inhibitors race.
BMS' Opdivo (nivolumab) and MSD's Keytruda (pembrolizumab) are leading, each notching up multiple approvals to date, although Roche's Tecentriq (atezolizumab) is a strong contender and the first to score a bladder cancer win. Roche extended this with first-line approval from the FDA last month and Tecentriq is also approved in non-small cell lung cancer, both indications for which Roche has filed in Australia.
Merck KGaA/Pfizer are also off the blocks with Bavencio (avelumab), which has a single FDA tick in metastatic merkel cell carcinoma.
Despite being the fifth checkpoint inhibitor to win an approval, Imfinzi is expected to be a blockbuster for the company. AstraZeneca in 2014 put the drug's potential peak sales in all cancers at US$6.5 billion, including combination use.
"Imfinzi is the cornerstone of our extensive immuno-oncology program, in development across many tumour types, as monotherapy and in combination," said AstraZeneca CEO Pascal Soriot. "This first approval for Imfinzi is an important milestone in our return to growth."
AstraZeneca recognises the drug needs first-line approvals if it is to compete and has key clinical trial results for it as a monotherapy and combination therapy in lung cancer due mid-year.
Megan Brodie
Megan.brodie@lushmedia.com.au
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