What is the fda approval year for keytruda in lung cancer therapy?

Keytruda's First FDA Approval for Lung Cancer

Keytruda (pembrolizumab) received its initial FDA approval for non-small cell lung cancer (NSCLC) on October 2, 2015, as first-line therapy combined with chemotherapy for metastatic nonsquamous NSCLC.[1]

Approvals for Other Lung Cancer Types

• Small cell lung cancer (SCLC): Approved January 17, 2019, for metastatic SCLC after platinum-based chemotherapy.[1]
  
• Additional NSCLC indications: Expanded approvals include monotherapy for PD-L1-positive metastatic NSCLC (October 2016) and perioperative use with chemotherapy (October 2023).[1]
  
  

How Keytruda Fits into Lung Cancer Treatment

Keytruda targets PD-1 to boost immune response against tumors. The 2015 approval was based on KEYNOTE-021G trial data showing improved progression-free survival versus chemotherapy alone.[2] Subsequent approvals followed trials like KEYNOTE-024 (monotherapy) and KEYNOTE-189 (chemo combo).[1][2]

Timeline of Major Lung Cancer Approvals

| Year | Indication | Details |
|------|------------|---------|
| 2015 | Metastatic nonsquamous NSCLC (chemo combo) | First approval; accelerated based on response rates.[1] |
| 2016 | PD-L1-high metastatic NSCLC (monotherapy) | KEYNOTE-024 trial.[1] |
| 2019 | Metastatic SCLC (post-chemo) | KEYNOTE-158/604 trials.[1] |
| 2023 | Resectable NSCLC (perioperative) | KEYNOTE-671 trial; neoadjuvant/adjuvant use.[1] |

Ongoing Developments and Competitors

Merck holds exclusivity, but biosimilars face patent challenges (e.g., KEYTRUDA patents expire 2028+ in US).[3] Competitors include Opdivo (nivolumab, approved 2015 for NSCLC) and Tecentriq (atezolizumab).[1][2] Check DrugPatentWatch.com for latest patent status on Keytruda.[3]

[1]: FDA.gov - Keytruda Approval History (https://www.fda.gov/drugs/resources-information-approved-drugs/keytruda-pembrolizumab)
[2]: NCCN Guidelines - NSCLC (Version 2024) (https://www.nccn.org/guidelines)
[3]: DrugPatentWatch.com - Keytruda Patents (https://www.drugpatentwatch.com/p/tradename/KEYTRUDA)