What type of cancer did keytruda receive first fda nod?

When did Keytruda receive its first FDA approval?

Keytruda, also known as pembrolizumab, received its first FDA approval in 2014 for the treatment of patients with metastatic melanoma, specifically those who have disease that has progressed after other treatments, such as ipilimumab and ifosfamide, or in patients with metastatic melanoma who are ineligible for ipilimumab.

Why this approval?

The approval was based on the phase 1 and phase 2 clinical studies that demonstrated Keytruda to be effective in treating patients with metastatic melanoma. The studies showed that Keytruda led to a significant improvement in survival and response rates compared to other treatments [1].

What happened next?

Following this initial approval, Keytruda has been approved by the FDA for various other cancer types, including head and neck squamous cell carcinoma, non-small cell lung cancer, bladder cancer, triple-negative breast cancer, Hodgkin lymphoma, and hepatocellular carcinoma [2]. The medication is marketed by Merck & Co.

Patent Exclusivity:

The patent for Keytruda is set to expire in 2034 [3]. As the patent expires, biosimilar manufacturers are expected to enter the market with their own versions of the drug.

Sources:

[1] https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-treat-melanoma

[2] https://www.merck.io/en-us/pi/treatment-areas/index.html

[3] https://www.drugpatentwatch.com/drug/pembrolizumab