What changed: Adrenocortical carcinoma

When this page itself was last checked or edited.

Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 1.0 year later, when the FDA's table was read.

Confirmed: the accelerated approval of 2021 converted to traditional approval 3.9 years after it was granted.

Confirmed: the accelerated approval of 2018 converted to traditional approval 5.2 years after it was granted.

Confirmed: the accelerated approval of 2023 converted to traditional approval 0.7 years after it was granted.

Confirmed: the accelerated approval of 2018 converted to traditional approval 4.8 years after it was granted.

Accelerated approval on a surrogate endpoint, with a confirmatory trial required.

Confirmed: the accelerated approval of 2017 converted to traditional approval 5.8 years after it was granted.

Five-year recurrence-free survival 79 percent with adjuvant mitotane against 75 percent with surveillance (hazard ratio 0.

A milestone in how this cancer is treated.

Confirmed: the accelerated approval of 2020 converted to traditional approval 2.6 years after it was granted.

Confirmed: the accelerated approval of 2020 converted to traditional approval 2.5 years after it was granted.

Confirmed: the accelerated approval of 2020 converted to traditional approval 2.5 years after it was granted.

Withdrawn: the indication came off the label 4.4 years after its accelerated approval.

Confirmed: the accelerated approval of 2018 converted to traditional approval 3.3 years after it was granted.

Confirmed: the accelerated approval of 2017 converted to traditional approval 4.3 years after it was granted.

Confirmed: the accelerated approval of 2019 converted to traditional approval 1.8 years after it was granted.

Accelerated approval on a surrogate endpoint, with a confirmatory trial required.

Withdrawn: the indication came off the label 1.8 years after its accelerated approval.

Confirmed: the accelerated approval of 2017 converted to traditional approval 3.6 years after it was granted.

Confirmed: the accelerated approval of 2018 converted to traditional approval 2.3 years after it was granted.

Accelerated approval on a surrogate endpoint, with a confirmatory trial required.

Accelerated approval on a surrogate endpoint, with a confirmatory trial required.

Accelerated approval on a surrogate endpoint, with a confirmatory trial required.

Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 6.4 years later, when the FDA's table was read.

Accelerated approval on a surrogate endpoint, with a confirmatory trial required.

Accelerated approval on a surrogate endpoint, with a confirmatory trial required.

Confirmed: the accelerated approval of 2016 converted to traditional approval 2.8 years after it was granted.

A milestone in how this cancer is treated.

Accelerated approval on a surrogate endpoint, with a confirmatory trial required.

Accelerated approval on a surrogate endpoint, with a confirmatory trial required.

Confirmed: the accelerated approval of 2017 converted to traditional approval 1.3 years after it was granted.

Accelerated approval on a surrogate endpoint, with a confirmatory trial required.

Accelerated approval on a surrogate endpoint, with a confirmatory trial required.

Mitotane monotherapy (target level 14-20 mg/L) with glucocorticoid replacement; local therapies (ablation, radiotherapy) for oligometastases.

Open en bloc adrenalectomy by an experienced surgeon with locoregional lymphadenectomy; adjuvant mitotane for high-risk (Ki-67 >10%, stage III, R1) for 2-5 years; adjuvant radiotherapy for R1.

Accelerated approval on a surrogate endpoint, with a confirmatory trial required.

Accelerated approval on a surrogate endpoint, with a confirmatory trial required.

Accelerated approval on a surrogate endpoint, with a confirmatory trial required.

Accelerated approval on a surrogate endpoint, with a confirmatory trial required.

Confirmed: the accelerated approval of 2015 converted to traditional approval 1.1 years after it was granted.

Accelerated approval on a surrogate endpoint, with a confirmatory trial required.

A milestone in how this cancer is treated.

Confirmed: the accelerated approval of 2014 converted to traditional approval 1.3 years after it was granted.

Accelerated approval, advanced melanoma after ipilimumab; first PD-1 inhibitor in the US

A milestone in how this cancer is treated.

A milestone in how this cancer is treated.

A milestone in how this cancer is treated.

Advanced adrenocortical carcinoma

A milestone in how this cancer is treated.

Inoperable adrenocortical carcinoma (functional and non-functional)

A milestone in how this cancer is treated.