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Roche files star biologic in Australia
Posted 26 April 2017
Roche has filed its latest cancer star Tecentriq (atezolizumab) in Australia, seeking approval in both lung and bladder cancer indications for the highly anticipated future blockbuster.
Roche confirmed to Pharma in Focus it is currently pursuing registration for its PD-L1 inhibitor atezolizumab in both urothelial cancer and non-small cell lung cancer (NSCLC).
The FDA extended its approval of Tecentriq in metastatic urothelial cancer last week after initially approving its use post-chemotherapy in May last year. The latest FDA decision allows Tecentriq to be used as the primary option in patients ineligible for chemotherapy.
Tecentriq has also already notched up an approval in NSCLC in the US, having been given the green light last October.
Tecentriq has caused a stir since 2015 when phase II trial results caused the FDA to grant it breakthrough therapy status in recognition of its enormous potential. The monoclonal antibody binds to PD-L1 expressed on tumour cells and works to activate the body's own T cells, restoring their ability to effectively detect and attack tumour cells.
When it was filed in the US in urothelial cancer early last year, the FDA slapped priority review and accelerated approval tags on it to rush it through in just four months, making 'atezo' the first PD-L1 inhibitor approved in this indication.
An approval in metastatic NSCLC followed just five months later, then approval in the first-line bladder cancer setting last week giving the expected blockbuster three green lights in less than a year.
Tecentriq's early success jumps Roche into the elite new checkpoint inhibitor club, along with MSD's Keytruda (pembrolizumab) and BMS' Opdivo (nivolumab).
Tecentriq's speedy approvals in the US are indicative of the enormous potential of this new class of immunotherapies, with Roche's star offering tipped to make upwards of US$2.5 billion in annual sales by 2020.
Merck KGaA, in an alliance with Pfizer, also has an anti-PD-L1 in development, Bavencio (avelumab), which was recently approved by the FDA in metastatic merkel cell carcinoma.
AstraZeneca's PD-L1 checkpoint inhibitor durvalumab is yet to notch up any approvals but is tipped to be the fifth member of the club - and a blockbuster in its own right by 2020.
Roche's filing of Tecentriq in Australia comes even before it is known to have been filed with the EMA. Given the enormous potential of the biological, it is likely Roche and local patient groups will be itching for the TGA to give it the same fast-tracked treatment as it received in the US.
And with new indications in the pipeline, Tecentriq is likely to be back to the FDA in the not too distant future seeking more approvals. It is in mid-stage trials on its own in triple negative breast cancer and in combination with Avastin (bevacizumab) in advanced renal cell carcinoma.
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 26 April 2017
Roche has filed its latest cancer star Tecentriq (atezolizumab) in Australia, seeking approval in both lung and bladder cancer indications for the highly anticipated future blockbuster.
Roche confirmed to Pharma in Focus it is currently pursuing registration for its PD-L1 inhibitor atezolizumab in both urothelial cancer and non-small cell lung cancer (NSCLC).
The FDA extended its approval of Tecentriq in metastatic urothelial cancer last week after initially approving its use post-chemotherapy in May last year. The latest FDA decision allows Tecentriq to be used as the primary option in patients ineligible for chemotherapy.
Tecentriq has also already notched up an approval in NSCLC in the US, having been given the green light last October.
Tecentriq has caused a stir since 2015 when phase II trial results caused the FDA to grant it breakthrough therapy status in recognition of its enormous potential. The monoclonal antibody binds to PD-L1 expressed on tumour cells and works to activate the body's own T cells, restoring their ability to effectively detect and attack tumour cells.
When it was filed in the US in urothelial cancer early last year, the FDA slapped priority review and accelerated approval tags on it to rush it through in just four months, making 'atezo' the first PD-L1 inhibitor approved in this indication.
An approval in metastatic NSCLC followed just five months later, then approval in the first-line bladder cancer setting last week giving the expected blockbuster three green lights in less than a year.
Tecentriq's early success jumps Roche into the elite new checkpoint inhibitor club, along with MSD's Keytruda (pembrolizumab) and BMS' Opdivo (nivolumab).
Tecentriq's speedy approvals in the US are indicative of the enormous potential of this new class of immunotherapies, with Roche's star offering tipped to make upwards of US$2.5 billion in annual sales by 2020.
Merck KGaA, in an alliance with Pfizer, also has an anti-PD-L1 in development, Bavencio (avelumab), which was recently approved by the FDA in metastatic merkel cell carcinoma.
AstraZeneca's PD-L1 checkpoint inhibitor durvalumab is yet to notch up any approvals but is tipped to be the fifth member of the club - and a blockbuster in its own right by 2020.
Roche's filing of Tecentriq in Australia comes even before it is known to have been filed with the EMA. Given the enormous potential of the biological, it is likely Roche and local patient groups will be itching for the TGA to give it the same fast-tracked treatment as it received in the US.
And with new indications in the pipeline, Tecentriq is likely to be back to the FDA in the not too distant future seeking more approvals. It is in mid-stage trials on its own in triple negative breast cancer and in combination with Avastin (bevacizumab) in advanced renal cell carcinoma.
Megan Brodie
megan.brodie@lushmedia.com.au
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