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FDA TO INTRODUCE MORE RIGOROUS TESTING FOR ACCELERATED APPROVALS OF CANCER DRUGS
The FDA has published new guidance recommending that, in most cases, cancer drug developers should conduct more rigorous trials to seek accelerated approval for their candidates. "Given the limitations of single-arm trials, a randomised controlled trial (RCT) is the preferred approach to support an application for accelerated approval," the agency said. The FDA wants to ensure that drugs that are granted expedited approvals actually provide clinical benefit.
FDA suggested one of two approaches.
The first conducting separate RCTs – one study with an early endpoint such as response rate to support the accelerated approval, while a second would be powered for a longer-term clinical endpoint such as progression-free survival (PFS) or overall survival (OS) in order to verify clinical benefit.
Alternatively, companies could also opt for a so-called "one-trial" approach in which a single RCT, used to support accelerated approval, would also be powered for the longer-term clinical endpoint, with follow-up in the same trial to verify clinical benefit.
Click here, or on the picture, for the full guidance document.
[Last updated 30 March 2023]
FDA TO INTRODUCE MORE RIGOROUS TESTING FOR ACCELERATED APPROVALS OF CANCER DRUGS
The FDA has published new guidance recommending that, in most cases, cancer drug developers should conduct more rigorous trials to seek accelerated approval for their candidates. "Given the limitations of single-arm trials, a randomised controlled trial (RCT) is the preferred approach to support an application for accelerated approval," the agency said. The FDA wants to ensure that drugs that are granted expedited approvals actually provide clinical benefit.
FDA suggested one of two approaches.
The first conducting separate RCTs – one study with an early endpoint such as response rate to support the accelerated approval, while a second would be powered for a longer-term clinical endpoint such as progression-free survival (PFS) or overall survival (OS) in order to verify clinical benefit.
Alternatively, companies could also opt for a so-called "one-trial" approach in which a single RCT, used to support accelerated approval, would also be powered for the longer-term clinical endpoint, with follow-up in the same trial to verify clinical benefit.
Click here, or on the picture, for the full guidance document.
[Last updated 30 March 2023]
CANCER DEATH RATE IN DECLINE
The cancer death rate in US has fallen by 33% since 1991, corresponding to an estimated 3.8 million deaths averted, according to a new report.
The rate of lives lost to cancer continues to shrink, by 1.5% between 2019 and 2020.
The cancer types with the highest survival rates are thyroid at 98%, prostate at 97%, testis at 95% and melanoma at 94%.
However, new cases of breast, uterine and prostate cancer are rising, e.g., breast cancer in women have been increasing by about 0.5% per year since the mid-2000s, and the prostate cancer incidence rate rose by 3% per year from 2014 through 2019, after two decades of decline. Prostate cancer remains the number one most frequently diagnosed malignancy amongst men in the US, with almost 290,000 men expected to be diagnosed with prostate cancer in 2023.
Contact D2MM directly, or click on this link for more details.
[Last updated 01 February 2023]
The cancer death rate in US has fallen by 33% since 1991, corresponding to an estimated 3.8 million deaths averted, according to a new report.
The rate of lives lost to cancer continues to shrink, by 1.5% between 2019 and 2020.
The cancer types with the highest survival rates are thyroid at 98%, prostate at 97%, testis at 95% and melanoma at 94%.
However, new cases of breast, uterine and prostate cancer are rising, e.g., breast cancer in women have been increasing by about 0.5% per year since the mid-2000s, and the prostate cancer incidence rate rose by 3% per year from 2014 through 2019, after two decades of decline. Prostate cancer remains the number one most frequently diagnosed malignancy amongst men in the US, with almost 290,000 men expected to be diagnosed with prostate cancer in 2023.
Contact D2MM directly, or click on this link for more details.
[Last updated 01 February 2023]
COLLAPSE IN LATE-STAGE STUDIES CONDUCTED IN UK
The number of clinical trials being conducted in the UK has fallen over the past five years, with a dramatic downturn for late-stage studies, with cancer studies declining by the same margin. As a result of this collapse in UK industry clinical trials, patient care, the NHS, and economic growth are all missing out.
Consistently slow and variable study set-up and recruitment timelines in the NHS are forcing many drugmakers to conduct their studies outside of the UK.
Contact D2MM directly, or click on the picture or here, for details about this story.
[Last updated 27 October 2022]
The number of clinical trials being conducted in the UK has fallen over the past five years, with a dramatic downturn for late-stage studies, with cancer studies declining by the same margin. As a result of this collapse in UK industry clinical trials, patient care, the NHS, and economic growth are all missing out.
Consistently slow and variable study set-up and recruitment timelines in the NHS are forcing many drugmakers to conduct their studies outside of the UK.
Contact D2MM directly, or click on the picture or here, for details about this story.
[Last updated 27 October 2022]
