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Opdivo wins 11th approval
Posted 24 September 2018
Bristol-Myers Squibb's top immuno-oncology drug Opdivo has been approved for second line use as monotherapy in liver cancer after Bayer's Nexavar.
The new approval comes around a year after a similar indication was granted in the US and specialists in Australia began to be officially informed to expect checkpoint inhibitors such as Opdivo to move into the space.
It is the eleventh indication for Opdivo across seven cancer areas. The treatment is already approved and has PBS listing for melanoma, advanced lung cancer, advanced renal cell carcinoma and advanced head and neck cancer. Indications yet to be reimbursed include relapsed/refractory classical Hodgkin lymphoma and now liver cancer.
Opdivo is currently the fastest growing brand among the top 20 PBS listed drugs and earned close to $220 million in pre-rebate benefits for the 12 months to July this year.
In November, the PBAC will consider a submission from BMS for it to be reimbursed for kidney cancer in combination with Yervoy.
In the liver indication, Opdivo appears to be well ahead of MSD's rival I-O drug Keytruda, which was only granted an FDA priority review for second line this July with a decision expected next month.
"This latest indication means Opdivo is the first immuno-oncology (I-O) therapy approved in Australia for hepatocellular carcinoma," BMS said in announcing the addition to its clutch of indications.
Opdivo's latest Australian approval was supported by results from a global phase 1/2 study (CA209040), which included patients with advanced HCC with or without hepatitis C or B infection, who were previously treated with Nexavar.
"This study demonstrated an overall objective response rate of 14.3 per cent (95 per cent CI 9-21), with 55 per cent of patients showing a duration of response for at least 12 months," BMS said.
It said the toxicity profile observed in patients with advanced HCC was similar to that observed in patients with other cancers, with the exception of a higher incidence of elevations in transaminases and bilirubin levels.
"Primary liver cancer is a rapidly rising cancer in Australia and it commonly results in death. There have been limited treatment options for patients with advanced stages of disease. The introduction of an immuno-oncology therapy is an important development for this serious cancer," said Associate Professor Simone Strasse of Sydney's Royal Prince Alfred Hospital.
"The TGA approval of Opdivo provides us with an encouraging approach and a new treatment option for appropriate patients with liver cancer that has not been controlled with prior therapy," she said.
New psoriasis treatment
In tandem with BMS' announcement of the new Opdivo approval, Sun Pharma announced TGA approval of its plaque psoriasis treatment Ilumya.
"We are pleased to have received this approval and look forward to bringing ILUMYATM to dermatologists and patients in Australia," said Hellen De Kloet, business head, Western Europe & Australia. "We are launching a patient support program to assist patients prescribed with Ilumya. The program is designed to supplement the support offered by doctors in their practice or in hospital departments," she said.
Sun Pharma regards Ilumya as one of its key specialty products of Sun Pharma. It was approved in the US in March 2018 and in Europe in September 2018.
Nick Lush
Posted 24 September 2018
Bristol-Myers Squibb's top immuno-oncology drug Opdivo has been approved for second line use as monotherapy in liver cancer after Bayer's Nexavar.
The new approval comes around a year after a similar indication was granted in the US and specialists in Australia began to be officially informed to expect checkpoint inhibitors such as Opdivo to move into the space.
It is the eleventh indication for Opdivo across seven cancer areas. The treatment is already approved and has PBS listing for melanoma, advanced lung cancer, advanced renal cell carcinoma and advanced head and neck cancer. Indications yet to be reimbursed include relapsed/refractory classical Hodgkin lymphoma and now liver cancer.
Opdivo is currently the fastest growing brand among the top 20 PBS listed drugs and earned close to $220 million in pre-rebate benefits for the 12 months to July this year.
In November, the PBAC will consider a submission from BMS for it to be reimbursed for kidney cancer in combination with Yervoy.
In the liver indication, Opdivo appears to be well ahead of MSD's rival I-O drug Keytruda, which was only granted an FDA priority review for second line this July with a decision expected next month.
"This latest indication means Opdivo is the first immuno-oncology (I-O) therapy approved in Australia for hepatocellular carcinoma," BMS said in announcing the addition to its clutch of indications.
Opdivo's latest Australian approval was supported by results from a global phase 1/2 study (CA209040), which included patients with advanced HCC with or without hepatitis C or B infection, who were previously treated with Nexavar.
"This study demonstrated an overall objective response rate of 14.3 per cent (95 per cent CI 9-21), with 55 per cent of patients showing a duration of response for at least 12 months," BMS said.
It said the toxicity profile observed in patients with advanced HCC was similar to that observed in patients with other cancers, with the exception of a higher incidence of elevations in transaminases and bilirubin levels.
"Primary liver cancer is a rapidly rising cancer in Australia and it commonly results in death. There have been limited treatment options for patients with advanced stages of disease. The introduction of an immuno-oncology therapy is an important development for this serious cancer," said Associate Professor Simone Strasse of Sydney's Royal Prince Alfred Hospital.
"The TGA approval of Opdivo provides us with an encouraging approach and a new treatment option for appropriate patients with liver cancer that has not been controlled with prior therapy," she said.
New psoriasis treatment
In tandem with BMS' announcement of the new Opdivo approval, Sun Pharma announced TGA approval of its plaque psoriasis treatment Ilumya.
"We are pleased to have received this approval and look forward to bringing ILUMYATM to dermatologists and patients in Australia," said Hellen De Kloet, business head, Western Europe & Australia. "We are launching a patient support program to assist patients prescribed with Ilumya. The program is designed to supplement the support offered by doctors in their practice or in hospital departments," she said.
Sun Pharma regards Ilumya as one of its key specialty products of Sun Pharma. It was approved in the US in March 2018 and in Europe in September 2018.
Nick Lush
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