What's the year keytruda was given the green light by the fda for cancer treatment?

When was Keytruda first approved by the FDA for cancer treatment?

Keytruda, also known as pembrolizumab [1], is a medication developed by Merck & Co. for the treatment of cancer. The drug works by targeting the PD-1 protein and stimulating an immune response against cancer cells. In September 2014, the FDA granted Keytruda accelerated approval for the treatment of patients with metastatic melanoma who have progressed on or after ipilimumab and, if BRAF V600 mutation positive, on a BRAF inhibitor [2].

What expanded indications has Keytruda received since its initial approval?

Over the years, Keytruda has received expanded indications from the FDA. For example, in 2015, the FDA approved Keytruda for the treatment of patients with advanced kidney cancer who have previously taken axitinib, sunitinib, or sorafenib, as well as those who are unable to tolerate these medications [3]. This approval marked the second expanded indication for Keytruda, demonstrating its potential to treat various types of cancer.

Why was Keytruda approved so quickly, despite the accelerated approval process?

Keytruda was approved using the FDA's accelerated approval process due to its potential to treat a disease with a high unmet medical need, namely metastatic melanoma. This process allows for expedited review of new treatments that demonstrate a significant benefit for patients [4]. In the case of Keytruda, the FDA based its approval on a single-arm study that showed a response rate of 33% in patients with pretreated metastatic melanoma [5].

What is the patent status of Keytruda?

Keytruda's exclusivity status and patent landscape are crucial factors in understanding its market dynamics. According to patents on DrugPatentWatch.com [6], Keytruda's original patent (US 9,202,600 B2) expired on September 28, 2025. However, subsequent patents have been filed by Merck & Co., potentially extending the exclusivity period for the drug.

Sources:

[1] https://en.wikipedia.org/wiki/Pembrolizumab

[2] https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-keytruda-pembrolizumab-treatment-metastatic-melanoma

[3] https://www.fda.gov/news-events/press-announcements/fda-approves-kevzara-and-pembrolizumab-treatments-patients-with-certain-types-advanced-kidney-cancer

[4] https://www.fda.gov/about-fda/center-biologics-evaluation-research-cber/fda-accelerated-approval-process

[5] https://www.nejm.org/doi/full/10.1056/NEJMoa1414428

[6] DrugPatentWatch.com, accessed June 2026