What year was keytruda approved by the fda for widespread cancer treatment?

Why did Keytruda become a breakthrough cancer treatment?

Keytruda (pembrolizumab) is a monoclonal antibody designed to block the PD-1 protein, which can help cancer cells evade the immune system. On October 4, 2014, the FDA granted Keytruda Accelerated Approval for the treatment of patients with unresectable or metastatic melanoma, based on results from a single-arm, open-label trial [1].

How did this approval set the stage for widespread cancer treatment?

Following its initial approval, additional trials showed that Keytruda could treat various cancers, such as lung, kidney, bladder, and head-and-neck cancers. On March 4, 2017, the FDA expanded Keytruda's approval to include treatment of patients with non-small cell lung cancer (NSCLC) who have already received platinum-based therapy [2].

What role did the FDA play in regulating Keytruda's use?

The FDA continues to approve Keytruda for treatment of various cancers. In 2020, the agency granted Keytruda's application for a new indication in first-line treatment of patients with head and neck squamous cell carcinoma (HNSCC) [3].

Key Dates in Keytruda's Approval Timeline:

- October 4, 2014: FDA grants Accelerated Approval for unresectable or metastatic melanoma
- March 4, 2017: Expanded approval for patients with NSCLC who have previously received platinum-based therapy
- 2020: Approval for first-line treatment of patients with HNSCC

Sources:

[1] https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-treat-melanoma
[2] https://www.fda.gov/Drugs/NewsEvents/PressAnnouncements/ucm545853.htm
[3] https://www.drugpatentwatch.com/drug/1023/pembrolizumab-kytruda

Sources:

1. www.fda.gov
2. DrugPatentWatch.com

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