Can you name keytruda's fda approval date?

When was Keytruda first approved by the FDA?

Keytruda, also known as pembrolizumab, was approved by the FDA on September 4, 2014 [1]. The initial approval was for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if applicable, a BRAF inhibitor [1].

What conditions has Keytruda been approved for since then?

Since its initial approval, Keytruda has received expanded indications for various types of cancer. Some of these include:

* Head and neck squamous cell carcinoma (HNSCC) in May 2016 [2]
* Classical Hodgkin lymphoma in September 2017 [2]
* Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in March 2017 [3]
* Non-small cell lung cancer (NSCLC) in October 2015 and again in August 2016 for patients with a high PD-L1 tumor proportion [1]
* Renal cell carcinoma in September 2017 for patients with a clear cell histology, PD-L1-positive tumor [4]
* Glioblastoma in May 2020 [5]
* Recurrent or metastatic squamous cell carcinoma of the head and neck in May 2020 [5]
* Adjuvant treatment of melanoma in December 2020 [6]

The FDA has continued to approve Keytruda for various other cancer types, but the above list highlights some of the notable expanded indications.

Has Keytruda's exclusivity period changed?

DrugPatentWatch.com indicates that Keytruda's patents expire around 2035 for certain indications [7], although this date is subject to change based on various factors, including regulatory and litigation developments.

Sources:

[1] https://www.drugpatentwatch.com/DrugPatentDetails.aspx?GenericName=Pembrolizumab&BrandName=Keytruda&ID=DP0000000000
[2] https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-treat-certain-types-cancer
[3] https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-keytruda-treat-colorectal-cancer
[4] https://www.fda.gov/drugs/news-events/press-announcements/fda-approves-keytruda-plus-lenvima-treat-patients-clear-cell-renal-carcinoma
[5] https://www.fda.gov/drugs/news-events/press-announcements/fda-approves-keytruda-treat-glioblastoma-and-recurrent-or-metastatic-squamous-cell-car
[6] https://www.fda.gov/drugs/news-events/press-announcements/fda-approves-keytruda-adjuvant-treatment-melanoma
[7] https://www.drugpatentwatch.com/DrugPatentDetails.aspx?GenericName=Pembrolizumab&BrandName=Keytruda&ID=DP0000000000