Can you name the year keytruda received fda approval for cancer immunotherapy?

Keytruda's Initial FDA Approval Year

Keytruda (pembrolizumab) received its first FDA approval on September 4, 2014, for unresectable or metastatic melanoma in patients whose tumors express PD-L1 or who have progressed after ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.[1]

Subsequent Approvals and Expansions

The FDA granted accelerated approval for melanoma, followed by full approval in 2015. Keytruda has since received over 40 approvals for cancers including NSCLC, head and neck squamous cell carcinoma, Hodgkin lymphoma, and MSI-H/dMMR tumors, with many in 2015-2017.[1][2]

Why 2014 Marks the Milestone for Cancer Immunotherapy

This approval was the first for a PD-1 inhibitor in the US, launching the PD-1/PD-L1 immunotherapy class. It built on earlier rituximab (1997) but shifted cancer treatment toward immune checkpoint blockade.[2]

Comparison to Other Immunotherapies

• Opdivo (nivolumab): First PD-1 approval in 2014 (December) for melanoma, shortly after Keytruda.[2]
  
• Tecentriq (atezolizumab): First PD-L1 inhibitor, approved 2016 for urothelial carcinoma.[2]
  Keytruda led in speed to market among these.
  
  

Current Status and Patent Timeline

Keytruda remains under patent until around 2028 in the US, with Merck facing biosimilar challenges. Exclusivity for some indications extends to 2025.[3]

[1]: FDA Approval History for Keytruda
[2]: Cancer.gov - Immunotherapy Timeline
[3]: DrugPatentWatch.com - Keytruda Patents