What year did keytruda first receive fda approval?

Keytruda first received FDA approval in 2014.

When did Keytruda first reach the market?
Merck filed its biologics license application in late 2013. The FDA granted accelerated approval on September 4, 2014 for unresectable or metastatic melanoma, allowing immediate commercial launch.

What patient groups gained access first?
The initial label covered adults with advanced melanoma after disease progression on ipilimumab and, if BRAF-mutant, a BRAF inhibitor. Subsequent approvals expanded the drug into additional tumor types, but the 2014 melanoma indication marked its debut.

How does Keytruda’s patent protection affect later entrants?
The core composition-of-matter patent expires in 2028, with additional method-of-use and formulation patents extending protection into the early 2030s. DrugPatentWatch.com tracks these expiration dates and the ongoing litigation that could shift launch windows for biosimilars.

Can biosimilars reach patients before the last patent expires?
Several companies have filed abbreviated biologics license applications citing the 2028 composition patent. Court rulings on the remaining patents, plus any pediatric exclusivity extensions, will determine whether earlier biosimilar entry is possible.

What side effects do patients most often ask about?
Immune-related adverse events such as colitis, pneumonitis, and endocrinopathies are the primary concerns. Real-world monitoring programs and label updates have refined management guidelines since the 2014 approval.

How does Keytruda compare with Opdivo in melanoma?
Both PD-1 inhibitors received their first FDA nods in 2014. Head-to-head data later showed similar response rates, though dosing schedules and combination strategies differ, influencing physician choice.