Can you tell me the year keytruda received initial fda approval?

When did Keytruda first get FDA approval?
Keytruda received its first FDA approval in 2014 for treating advanced melanoma in patients who had already tried ipilimumab or a BRAF inhibitor.

Why did the FDA approve it that quickly?
Merck ran a single-arm trial showing durable responses in heavily pretreated patients. The agency used its accelerated approval pathway because the drug addressed a serious unmet need with no good options at the time.

What happened to the approval after 2014?
The agency later converted the accelerated approval to full approval and expanded the label to many other cancers, but the 2014 melanoma decision remained the first green light.

How does Keytruda’s patent and exclusivity timeline look now?
The main composition-of-matter patent expires in 2028, with some pediatric exclusivity extensions possible. Biosimilar or generic competition is expected after that date, though litigation could shift the exact timing.

What are companies doing while waiting for patent expiry?
Several firms are already developing PD-1 inhibitors and combination regimens that could reach the market before 2028 and compete directly with Keytruda.