Numbers & Timeline
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Timeline of FDA Approvals for Melanoma
Timeline of FDA Approvals for Melanoma
2007
NOV 15 The Melanoma Research Alliance (MRA), founded by Debra & Leon Black, held launch meeting of global experts to identify scientific and clinical questions that need to be addressed in order to transform the field of melanoma detection and treatment.
2011
MAR 25 FDA approved Yervoy — the first anti-CTLA-4 checkpoint immunotherapy — for patients with advanced melanoma. This represents the first checkpoint immunotherapy to ever earn FDA approval, for any cancer. It also represents the first new melanoma therapy to earn FDA approval in over a decade.
MAR 29 FDA approved Sylatron — a type of immunotherapy called an interferon — for the adjuvant treatment of patients with melanoma following surgery.
AUG 17 FDA approved Zelboraf — the first BRAF inhibitor therapy — for patients with advanced melanoma with a BRAF mutation.
2013
MAY 29 FDA approved Tafinlar — a BRAF inhibitor therapy — for patients with advanced melanoma with a BRAF mutation.
MAY 29 FDA approved Mekinist — a MEK inhibitor therapy — for patients with advanced melanoma with a BRAF mutation.
2014
JAN 10 FDA approved the combination of Mekinist + Tafinlar for patients with advanced melanoma with a BRAF mutation.
SEPT 4 FDA approved Keytruda — the first anti-PD-1 checkpoint immunotherapy — for patients with advanced melanoma. This represents the first anti-PD-1 checkpoint immunotherapy to ever earn FDA approval, for any cancer.
DEC 22 FDA approved Opdivo — an anti-PD-1 checkpoint immunotherapy — for patients with advanced melanoma.
2015
SEPT 30 FDA approved the combination of Opdivo + Yervoy for patients with advanced melanoma.
OCT 27 FDA approved Imlygic — an oncolytic virus therapy — for patients with advanced melanoma.
NOV 10 FDA approved the combination of Cotellic + Zelboraf for patients with advanced melanoma with a BRAF mutation.
2017
DEC 20 FDA approved Opdivo for the adjuvant treatment of patients
with melanoma following surgery.
2018
APR 30 FDA approved the combination of Tafinlar + Mekinist for the adjuvant treatment of patients with melanoma with a BRAF mutation following surgery.
JUN 27 FDA approved the combination of Braftovi + Mektovi for patients with advanced melanoma with a BRAF mutation.
2019
FEB 15 FDA approved Keytruda for the adjuvant treatment of patients with melanoma following surgery.
2020
JULY 30 FDA approved the combination of Tecentriq + Zelboraf + Cotellic — bringing BRAF/MEK targeted therapy together with PD-L1 checkpoint immunotherapy — for patients with advanced melanoma with a BRAF mutation. This represents the first ‘triplet’ therapy to earn FDA approval in melanoma.
2021
DEC 3 FDA expanded the approval of Keytruda for the adjuvant treatment of patients with stage IIB or IIC melanoma following surgery.
2022
JAN 25 FDA approved Kimmtrak — a novel immunotherapy called a bispecific fusion protein — for patients with unresectable or metastatic uveal melanoma. This represents the first bispecific fusion protein immunotherapy to ever earn FDA approval, for any cancer. It also represents the first therapy to be approved specifically for a rare melanoma subtype.
MAR 18 FDA approved Opdualag — which combines two distinct checkpoint immunotherapies into one medicine — for patients with advanced melanoma. This represents the first LAG-3 checkpoint immunotherapy to ever earn FDA approval, for any cancer.
2007
NOV 15 The Melanoma Research Alliance (MRA), founded by Debra & Leon Black, held launch meeting of global experts to identify scientific and clinical questions that need to be addressed in order to transform the field of melanoma detection and treatment.
2011
MAR 25 FDA approved Yervoy — the first anti-CTLA-4 checkpoint immunotherapy — for patients with advanced melanoma. This represents the first checkpoint immunotherapy to ever earn FDA approval, for any cancer. It also represents the first new melanoma therapy to earn FDA approval in over a decade.
MAR 29 FDA approved Sylatron — a type of immunotherapy called an interferon — for the adjuvant treatment of patients with melanoma following surgery.
AUG 17 FDA approved Zelboraf — the first BRAF inhibitor therapy — for patients with advanced melanoma with a BRAF mutation.
2013
MAY 29 FDA approved Tafinlar — a BRAF inhibitor therapy — for patients with advanced melanoma with a BRAF mutation.
MAY 29 FDA approved Mekinist — a MEK inhibitor therapy — for patients with advanced melanoma with a BRAF mutation.
2014
JAN 10 FDA approved the combination of Mekinist + Tafinlar for patients with advanced melanoma with a BRAF mutation.
SEPT 4 FDA approved Keytruda — the first anti-PD-1 checkpoint immunotherapy — for patients with advanced melanoma. This represents the first anti-PD-1 checkpoint immunotherapy to ever earn FDA approval, for any cancer.
DEC 22 FDA approved Opdivo — an anti-PD-1 checkpoint immunotherapy — for patients with advanced melanoma.
2015
SEPT 30 FDA approved the combination of Opdivo + Yervoy for patients with advanced melanoma.
OCT 27 FDA approved Imlygic — an oncolytic virus therapy — for patients with advanced melanoma.
NOV 10 FDA approved the combination of Cotellic + Zelboraf for patients with advanced melanoma with a BRAF mutation.
2017
DEC 20 FDA approved Opdivo for the adjuvant treatment of patients with melanoma following surgery.
2018
APR 30 FDA approved the combination of Tafinlar + Mekinis for the adjuvant treatment of patients with melanoma with a BRAF mutation following surgery.
JUN 27 FDA approved the combination of Braftovi + Mektovi for patients with advanced melanoma with a BRAF mutation..
2019
FEB 15 FDA approved Keytruda for the adjuvant treatment of patients with melanoma following surgery.
2020
JULY 30 FDA approved the combination of Tecentriq + Zelboraf + Cotellic — bringing BRAF/MEK targeted therapy together with PD-L1 checkpoint immunotherapy — for patients with advanced melanoma with a BRAF mutation. This represents the first ‘triplet’ therapy to earn FDA approval in melanoma.
2021
DEC 3 FDA expanded the approval of Keytruda for the adjuvant treatment of patients with stage IIB or IIC melanoma following surgery.
2022
JAN 25 FDA approved Kimmtrak — a novel immunotherapy called a bispecific fusion protein — for patients with unresectable or metastatic uveal melanoma. This represents the first bispecific fusion protein immunotherapy to ever earn FDA approval, for any cancer. It also represents the first therapy to be approved specifically for a rare melanoma subtype.
MAR 18 FDA approved Opdualag — which combines two distinct checkpoint immunotherapies into one medicine — for patients with advanced melanoma. This represents the first LAG-3 checkpoint immunotherapy to ever earn FDA approval, for any cancer.