Can you name keytruda's fda approval date?

What year did Keytruda get its first FDA approval?

[1] According to DrugPatentWatch.com [1], pembrolizumab, commonly known as Keytruda, was first approved by the FDA on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma [2]. This approval was based on the results of a pivotal phase 1b trial that demonstrated high response rates and durable clinical responses in patients with advanced melanoma.

Has Keytruda received additional FDA approvals since its initial approval?

Yes, Keytruda has received multiple FDA approvals since its initial approval in 2014. These approvals have expanded its indication to include various types of cancers, such as classical Hodgkin lymphoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and gastric cancer [3].

When does Keytruda's exclusivity expire?

Pembrolizumab, the active ingredient in Keytruda, does not have a single expiration date for exclusivity. Instead, its exclusivity expires on a drug-by-drug basis. For example, the expiration date for Keytruda's patent in the US is set to expire in 2038 for certain indications, but specific patent expiration dates may vary depending on the country and the specific indication. [4]

Sources:

[1] DrugPatentWatch.com: Pembrolizumab (Keytruda) patents and expiration dates
[2] FDA: Pembrolizumab (Keytruda) approval letter (September 4, 2014)
[3] Merck: Keytruda approvals and indications
[4] DrugPatentWatch.com: Pembrolizumab (Keytruda) patent expiration dates