What was the primary cancer for keytruda's first fda approval?

What type of cancer received Keytruda’s first FDA approval?

Keytruda (pembrolizumab) received its first FDA approval in September 2014 for unresectable or metastatic melanoma.

How did the melanoma approval differ from later Keytruda uses?

The initial approval covered only advanced melanoma. Subsequent approvals added non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, and many other tumor types, often in combination regimens or earlier disease stages.

Why was melanoma chosen for the first approval?

Melanoma showed a strong response rate in early trials for patients whose disease had progressed after prior treatment. The data supported accelerated approval under the FDA’s breakthrough therapy program.

When did exclusivity expire?

The original composition-of-matter patent for pembrolizumab expired in 2028 in the United States, with some method-of-use patents extending further. [1]

What biosimilar or follow-on competition exists?

No FDA-approved pembrolizumab biosimilars are on the U.S. market as of 2024. Multiple developers have candidates in late-stage trials, but regulatory and litigation timelines remain uncertain.

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