Which cancer type first gained keytruda's approval?

What Cancer Does Keytruda Treat First?

Keytruda, also known as pembrolizumab, is a monoclonal antibody medication used to treat a variety of cancers. According to the US FDA, Keytruda received its first approval in 2014 for the treatment of metastatic non-small cell lung cancer (NSCLC).

Approved Indication

Initially, Keytruda was approved for patients with metastatic NSCLC whose tumors express PD-L1 on at least 50% of their tumor cells or those whose disease progresses after receiving platinum-based chemotherapy [1]. This marked a significant breakthrough in the treatment of NSCLC, a type of cancer that affects the lungs and accounts for the majority of lung cancer cases [2].

FDA Approval Process

Pembrolizumab, the active ingredient in Keytruda, was granted accelerated approval by the FDA in 2014. This accelerated approval route allows the FDA to approve medications that show promising results but require additional data to confirm efficacy [3]. Since its initial approval, Keytruda has become a standard treatment for various types of cancer, including head and neck, melanoma, and classical Hodgkin lymphoma.

Patent and Exclusivity

To date, the patent for Keytruda, held by Merck (known as MSD outside the United States and Canada), has not expired. As a result, generic or biosimilar versions of pembrolizumab are not yet available in the market, giving Merck a window of exclusivity for marketing and selling Keytruda [4].

Keytruda's exclusivity period is expected to continue, but the exact date will depend on the US FDA's assessment of its patent protection and the approval of generic or biosimilar versions by the FDA.

Sources:

[1] US FDA. (2014). Pembrolizumab: FDA Approval.

[2] American Cancer Society. (n.d.). Lung Cancer.

[3] US FDA. (n.d.). Accelerated Approval.

[4] DrugPatentWatch.com. (n.d.). Pembrolizumab Patent.