Timeline of Cancer Immunotherapy Approvals by FDA 

08/29/2010 - Dendreon Corporation - Provenge - Advanced prostate cancer

 

03/28/2011 - Bristol-Myers Squibb - Yervoy - Advanced melanoma

 

09/04/2014 - Merck - Keytruda - Previously treated advanced melanoma

 

12/03/2014 - Amgen - Blincyto - Philadelphia negative precursor B-cell ALL

 

12/22/2014 - Bristol-Myers Squibb - Opdivo - Previously treated advanced melanoma

 

03/04/2015 - Bristol-Myers Squibb - Opdivo - Previously treated advanced squamous NSCLC

 

10/01/2015 - Bristol-Myers Squibb - Opdivo+Yervoy - BRAF V600 wild-type melanoma

 

10/02/2015 - Merck - Keytruda - Previously treated advanced NSCLC

 

10/09/2015 - Bristol-Myers Squibb - Opdivo - Previously treated advanced non-squamous NSCLC

 

10/27/2015 - Amgen - Imlygic - Melanoma lesions in the skin and lymph nodes

 

10/28/2015 - Bristol-Myers Squibb - Yervoy - To lower the risk that melanoma will return after surgery

 

11/23/2015 - Bristol-Myers Squibb - Opdivo - Previously treated advanced renal cell carcinoma

 

12/18/2015 - Merck - Keytruda - First-line treatment for advanced melanoma

 

01/23/2016 - Bristol-Myers Squibb - Opdivo+Yervoy - Metastatic melanoma across BRAF status

 

05/17/2016 - Bristol-Myers Squibb - Opdivo - Classical Hodgkin lymphoma post auto-HSCT

 

05/18/2016 - Roche - Tecentriq - Previously treated advanced urothelial carcinoma

 

08/05/2016 - Merck - Keytruda - Recurrent or metastatic head and neck squamous cell carcinoma

 

09/01/2016 - Amgen - Blincyto - Pediatric Philadelphia negative r/r precursor B-cell ALL

 

10/18/2016 - Roche - Tecentriq - Advanced NSCLC for patients with EGFR or ALK abnormalities

 

10/24/2016 - Merck - Keytruda - First-line NSCLC for patients who have high PD-L1 expression

 

11/10/2016 - Bristol-Myers Squibb - Opdivo - Recurrent or metastatic H&N squamous cell carcinoma

 

02/02/2017 - Bristol-Myers Squibb - Opdivo - Previously treated advanced urothelial carcinoma

 

03/15/2017 - Merck - Keytruda - Refractory classical Hodgkin lymphoma

 

04/17/2017 - Roche - Tecentriq - As initial treatment for certain advanced urothelial carcinoma patients

 

03/23/2017 - Pfizer - Bavencio - Metastatic Merkel cell carcinoma

 

05/01/2017 - AstraZeneca - Imfinzi - Previously treated advanced urothelial carcinoma

 

05/09/2017 - Pfizer - Bavencio - Previously treated advanced urothelial carcinoma

 

05/10/2017 - Merck - Keytruda+Chemo - First-line NSCLC irrespective of PD-L1 expression

 

05/18/2017 - Merck - Keytruda - Previously treated advanced urothelial carcinoma

 

05/18/2017 - Merck - Keytruda - As initial treatment for certain advanced urothelial carcinoma patients

 

05/23/2017 - Merck - Keytruda - Advanced MSI-H or dMMR tumors

 

07/24/2017 - Bristol-Myers Squibb - Yervoy - Pediatric patients 12yrs+ with metastatic melanoma

 

08/01/2017 - Bristol-Myers Squibb - Opdivo - Advanced MSI-H or dMMR metastatic colorectal cancer

 

08/30/2017 - Novartis - Kymriah - Relapsed/Refractory pediatric ALL

 

09/22/2017 - Merck - Keytruda - Recurrent Locally Advanced or Metastatic Gastric Cancer 

 

09/22/2017 - Bristol-Myers Squibb - Opdivo - Hepatocellular carcinoma after prior sorafenib use

 

10/18/2017 - Gilead Sciences - Yescarta - Aggressive NHL

 

12/20/2017 - Bristol - Opdivo - Adjuvant for resected melanoma w/ LN involvment or metastatic disease.

 

02/16/2018 - Astra - Imfinzi - Stage III unresectable NSCLC after no progression w/ chemoradiation.

 

03/29/2018 - Amgen - Blincyto - MRD+ B-Cell Precursor ALL In Adults And Children.

 

04/16/2018 - Bristol - Opdivo+Yervoy - First-line patients w/ intermediate and poor risk advanced RCC.

 

05/01/2018 - Novartis - Kymriah - relapsed or refractory large B-cell lymphoma.

 

06/12/2018 - Merck - Keytruda - advanced cervical cancer w/ progression during or after chemo.

06/13/2018 - Merck - Keytruda - refractory primary mediastinal large B-cell lymphoma (PMBCL).

07/11/2018 - Bristol - Opdivo+Yervoy - MSI-H/dMMR mCRC Patients who progress after chemo.

08/17/2018 - Bristol - Opdivo - Advanced SCLC that has progressed after chemo + one line of therapy.

09/28/2018 - Regn/Sny - Libtayo - Advanced Cutaneous Squamous Cell Carcinoma.

10/31/2018 - Merck - Keytruda - In combo with chemo in 1st line metastatic squamous NSCLC.

12/06/2018 - Roche - Tecentriq - In combo with avastin and chemo in metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

12/19/2018 - Merck - Keytruda - Metastatic Merkel cell carcinoma.

02/19/2019 - Merck - Keytruda - Adjuvant treatment of melanoma with lymph node involvement after complete resection.

03/08/2019 - Roche - Tecentriq - In combo with avastin in inoperable PD-L1 high metastatic TNBC.

 

03/19/2019 - Roche - Tecentriq - In combo with chemo for the initial treatment of (ES-SCLC).

04/11/2019 - Merck - Keytruda - 1L stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1  ≥1% with no EGFR or ALK genomic tumor aberrations.

04/19/2019 - Merck - Keytruda - In combination with Inlyta for 1L advanced RCC.

05/14/2019 - Merck KGaA - Bavencio - In combination with Inlyta for 1L advanced RCC.

06/11/2019 - Merck - Keytruda - 1L advanced HNSCC for patients whose tumors express PD-L1

06/11/2019 - Merck - Keytruda - 1L advanced HNSCC in combo with chemo for all patients.

06/18/2019 - Merck - Keytruda - SCLC mono therapy for patients with progression on or after chemo and at least one other prior line of therapy.