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Bayer blood cancer drug scores quick US win
Posted 19 September 2017
Bayer has added a new drug to its fledgling oncology pipeline, gaining a lightning-fast early approval in the US for new follicular lymphoma candidate Aliqopa (copanlisib).
The drug was filed in May under priority review and the American regulator took just four months to approve it for relapsed follicular lymphoma patients who have received at least two prior treatments.
Bayer Australia said while it needed to wait for phase III trial results before deciding whether to register Aliqopa locally, the intention was to bring it to Australia should late-stage data prove positive.
If registered in Australia, Aliqopa, a member of the PI3K class, will compete with Gilead's Zydelig (idelalisib). Zydelig won TGA approval in 2015 in the same third-line setting but was only PBS listed this month, 14 months after being recommended by the PBAC.
Aliqopa was approved in the US on theback of Phase II data that showed it provoked a response in almost 59 per cent of relapsed or refractory follicular lymphoma patients, eliminating the cancer in 14.4 per cent.
The US approval marks Bayer's first successful foray into blood cancer with Aliqopa now joining existing oncology drugs Stivarga (regorafenib), Xofigo (radium (223Ra) dichloride) and Nexavar (sorafenib).
Approved in Australia in metastatic colorectal cancer and gastrointestinal stromal tumours, Stivarga recently scored a nod in the US as second line in liver cancer.
While Zydelig has an edge over the new Bayer drug as it is administered in tablet form whereas Aliqopa is an injectable, Bayer may yet succeed where Gilead has failed after Gilead was forced to abandon first-line trials in March following serious side effects and multiple deaths among trial participants.
Also looking for a win in follicular lymphoma, Roche's Gazyva (obinutuzumab) was rejected when it first sought a PBAC recommendation in this indication last November. It is returning again in November this year looking for reimbursement in the first-line setting.
Roche recently filed Gazyva in first-line follicular lymphoma in Europe and the US.
Janssen and AbbVie have also signalled their intention to file their cancer drug Imbruvica (ibrutinib) in follicular lymphoma next year.
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 19 September 2017
Bayer has added a new drug to its fledgling oncology pipeline, gaining a lightning-fast early approval in the US for new follicular lymphoma candidate Aliqopa (copanlisib).
The drug was filed in May under priority review and the American regulator took just four months to approve it for relapsed follicular lymphoma patients who have received at least two prior treatments.
Bayer Australia said while it needed to wait for phase III trial results before deciding whether to register Aliqopa locally, the intention was to bring it to Australia should late-stage data prove positive.
If registered in Australia, Aliqopa, a member of the PI3K class, will compete with Gilead's Zydelig (idelalisib). Zydelig won TGA approval in 2015 in the same third-line setting but was only PBS listed this month, 14 months after being recommended by the PBAC.
Aliqopa was approved in the US on theback of Phase II data that showed it provoked a response in almost 59 per cent of relapsed or refractory follicular lymphoma patients, eliminating the cancer in 14.4 per cent.
The US approval marks Bayer's first successful foray into blood cancer with Aliqopa now joining existing oncology drugs Stivarga (regorafenib), Xofigo (radium (223Ra) dichloride) and Nexavar (sorafenib).
Approved in Australia in metastatic colorectal cancer and gastrointestinal stromal tumours, Stivarga recently scored a nod in the US as second line in liver cancer.
While Zydelig has an edge over the new Bayer drug as it is administered in tablet form whereas Aliqopa is an injectable, Bayer may yet succeed where Gilead has failed after Gilead was forced to abandon first-line trials in March following serious side effects and multiple deaths among trial participants.
Also looking for a win in follicular lymphoma, Roche's Gazyva (obinutuzumab) was rejected when it first sought a PBAC recommendation in this indication last November. It is returning again in November this year looking for reimbursement in the first-line setting.
Roche recently filed Gazyva in first-line follicular lymphoma in Europe and the US.
Janssen and AbbVie have also signalled their intention to file their cancer drug Imbruvica (ibrutinib) in follicular lymphoma next year.
Megan Brodie
megan.brodie@lushmedia.com.au
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