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Gilead to bring CAR-T to Aust
Posted 1 November 2017
Gilead is considering Australian filing plans for its breakthrough chimeric antigen receptor T cell (CAR-T) therapy Yescarta (axicabtagene ciloleucel), according to the company.
"At this early stage, plans and timelines for bringing Yescarta to market in Australia are under discussion within Gilead," a spokesperson from Gilead Sciences ANZ said.
Although exact details of its potential plans remain undisclosed, the company compared Yescarta, "[one of] the most significant breakthroughs in cancer treatment in decades," to the huge successes of its hepatitis C business, suggesting big hopes for the new cancer therapy.
"We have transformed the lives of millions of people living with HIV and cured more than one million people of HCV. We aim to similarly transform the lives of cancer patients with our scientific innovation."
Yescarta was approved in the US earlier this month for the treatment of relapsed or refractory large B-cell lymphoma, making it the second CAR-T to be approved after Novartis' Kymriah (tisagenlecleucel-T). It is also under review in Europe with a breakthrough designation tag.
Gilead spent USD12 billion to acquire the drug just a month before the US approval, buying out its original sponsor Kite Pharma in one of the biggest acquisitions of recent history.
The new therapy genetically modifies individual patients' own T-cells to attack cancer tumours. According to a statement from its recent US approval, manufacturing turnaround of the personalised therapies takes a median of 17 days to complete.
Their complicated and individualised manufacturing process also means CAR-T therapies carry a hefty price tag with the US market price of Yescarta coming in at USD373,000 while Kymriah is priced at USD475,000.
None-the-less the progress of the new class of therapies has not all been smooth sailing. French biotech Cellectis had its CAR-T trials halted in September after a patient died from a severe cytokine release syndrome (CRS) reaction, a common side-effect of the gene therapies.
Yajun Ma
yajun.ma@lushmedia.com.au
Posted 1 November 2017
Gilead is considering Australian filing plans for its breakthrough chimeric antigen receptor T cell (CAR-T) therapy Yescarta (axicabtagene ciloleucel), according to the company.
"At this early stage, plans and timelines for bringing Yescarta to market in Australia are under discussion within Gilead," a spokesperson from Gilead Sciences ANZ said.
Although exact details of its potential plans remain undisclosed, the company compared Yescarta, "[one of] the most significant breakthroughs in cancer treatment in decades," to the huge successes of its hepatitis C business, suggesting big hopes for the new cancer therapy.
"We have transformed the lives of millions of people living with HIV and cured more than one million people of HCV. We aim to similarly transform the lives of cancer patients with our scientific innovation."
Yescarta was approved in the US earlier this month for the treatment of relapsed or refractory large B-cell lymphoma, making it the second CAR-T to be approved after Novartis' Kymriah (tisagenlecleucel-T). It is also under review in Europe with a breakthrough designation tag.
Gilead spent USD12 billion to acquire the drug just a month before the US approval, buying out its original sponsor Kite Pharma in one of the biggest acquisitions of recent history.
The new therapy genetically modifies individual patients' own T-cells to attack cancer tumours. According to a statement from its recent US approval, manufacturing turnaround of the personalised therapies takes a median of 17 days to complete.
Their complicated and individualised manufacturing process also means CAR-T therapies carry a hefty price tag with the US market price of Yescarta coming in at USD373,000 while Kymriah is priced at USD475,000.
None-the-less the progress of the new class of therapies has not all been smooth sailing. French biotech Cellectis had its CAR-T trials halted in September after a patient died from a severe cytokine release syndrome (CRS) reaction, a common side-effect of the gene therapies.
Yajun Ma
yajun.ma@lushmedia.com.au
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