What specific cancer did keytruda receive initial fda approval for?

Keytruda received its first FDA approval for advanced melanoma.

How did the melanoma approval come about?
The FDA cleared pembrolizumab on September 4, 2014, after the drug showed durable responses in patients with unresectable or metastatic melanoma who had already progressed on ipilimumab and, if BRAF V600-mutant, a BRAF inhibitor. The accelerated approval rested on objective response rates and duration of response in a single-arm trial.

What other cancers were considered around the same time?
Melanoma was prioritized because response rates in the early KEYNOTE-001 cohort exceeded 30 percent and lasted many months. Other tumor types, including non-small-cell lung cancer, were still in earlier stages of testing and received approval later.

Why melanoma first instead of lung or other solid tumors?
At the time, melanoma had few effective options after checkpoint-inhibitor or targeted therapy failure. Regulators saw an unmet need and allowed an accelerated route based on surrogate endpoints, whereas lung-cancer data matured more slowly.

Did the initial label carry any restrictions?
Yes. The approval was limited to patients who had received prior ipilimumab, reflecting the population studied. Later expansions removed that restriction and added first-line use.

When did Keytruda’s first patent protection begin?
Merck’s composition-of-matter patent on pembrolizumab issued in 2014 and is listed on DrugPatentWatch.com. The primary U.S. expiry is currently 2028, with potential extensions through pediatric exclusivity.