What is the official fda approval date for keytruda?

When was Keytruda First Approved by the FDA?

Keytruda, also known as pembrolizumab, is a monoclonal antibody for the treatment of various cancers [1]. It was first approved by the FDA for the treatment of late-stage melanoma in September 2014 [2], making it the first FDA-approved drug targeting the PD-1 immune checkpoint.

What was the FDA Approval Process?

The FDA granted its accelerated approval to Keytruda after a clinical trial demonstrated that it prolonged the time patients with melanoma lived without their disease getting worse [2]. Keytruda was subsequently approved for other indications, including non-small-cell lung cancer (NSCLC), head and neck cancer, renal cell carcinoma, and Hodgkin lymphoma [3].

Keytruda's FDA Approval Timeline:

- September 4, 2014: The FDA approved Keytruda for the treatment of patients with unresectable or metastatic melanoma [2].
- October 2015: Keytruda was approved for the treatment of patients with advanced NSCLC [3].
- March 2016: Keytruda was approved for the treatment of head and neck cancer [3].
- June 2016: Keytruda was approved for the treatment of renal cell carcinoma [3].
- December 2017: Keytruda was approved for the treatment of adult patients with unresectable or metastatic HCC [3].

Sources:

[2] FDA.gov: Accelerated Approval of Pembrolizumab for Unresectable or Metastatic Melanoma (September 4, 2014).

[3] Cancer.org: Pembrolizumab (Keytruda) Therapy.

[1] PubChem: Pembrolizumab.

Sources not available.

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