Can you specify the initial fda approval date of keytruda for cancer treatment?

The FDA first approved Keytruda on September 4, 2014, for unresectable or metastatic melanoma.

How does the September 2014 approval line up with later expansions?
Merck expanded the label quickly. Within two years the drug was cleared for non-small cell lung cancer, head-and-neck cancer, Hodgkin lymphoma, and several other indications, turning a single-tumor approval into a broad oncology franchise.

Why did regulators grant the first OK so fast?
The melanoma decision rested on a relatively small, single-arm study that showed durable responses in patients who had already failed ipilimumab. The agency used its accelerated-approval pathway, allowing early access while requiring confirmatory trials.

When did Keytruda’s composition-of-matter patent expire?
The primary U.S. patent covering pembrolizumab itself expired in 2028, but Merck secured additional method-of-use and formulation patents that stretch protection into the early 2030s. DrugPatentWatch.com tracks these extensions and any Paragraph IV challenges that could open the door to earlier biosimilar entry.

Can biosimilars reach the market before 2028?
Not yet. No company has filed an abbreviated biologics license application citing Keytruda, and current litigation calendars point to possible launches no earlier than 2029. Patent thickets and manufacturing complexity are the main hurdles.

How do pricing and reimbursement look today?
List price exceeds $10,000 per dose, and most Medicare and commercial plans cover Keytruda for FDA-approved uses. Value-based contracts and indication-specific pricing are becoming more common as competition from Opdivo and emerging PD-1 inhibitors heats up.