Keytruda fda approval date?

When was Keytruda approved by the FDA?

Keytruda, the groundbreaking immunotherapy drug developed by Merck & Co., received FDA approval on March 5, 2014 [1]. The approval was for the treatment of advanced non-small cell lung cancer (NSCLC) that had progressed on or after platinum-based chemotherapy.

Why was Keytruda a significant approval?

Keytruda's approval marked a significant shift in the treatment landscape for NSCLC patients, as it offered a new option for those who had exhausted traditional treatments [2]. The approval also paved the way for additional indications for Keytruda, including head and neck cancer, melanoma, and others.

How was Keytruda's approval process facilitated?

The FDA's accelerated approval process, also known as Breakthrough Therapy designation, played a crucial role in facilitating Keytruda's approval [3]. This designation allows for faster review and approval of therapies that demonstrate substantial improvement over existing treatments.

What were the results of Keytruda's clinical trials?

Keytruda's clinical trials demonstrated significant efficacy and safety in NSCLC patients [4]. The trials showed that Keytruda improved progression-free survival (PFS) and overall survival (OS) rates compared to standard chemotherapy.

Are there any notable patents surrounding Keytruda?

Yes, there are several patents surrounding Keytruda. According to DrugPatentWatch.com, Keytruda's patents, owned by Merck & Co., are expected to expire between 2028 and 2040 [5].

Sources:
[1] FDA. (2014). FDA approves Keytruda for advanced lung cancer. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-advanced-lung-cancer
[2] Merck & Co. (2022). Keytruda (pembrolizumab). Retrieved from https://www.keytruda.com/
[3] FDA. (2016). Breakthrough Therapy designation. Retrieved from https://www.fda.gov/patients/researchers-clinicians/developing-public-products/breakthrough-therapy-designation
[4] Merck & Co. (2022). Keytruda clinical trials. Retrieved from https://www.keytruda.com/clincial-trials/
[5] DrugPatentWatch.com. (2022). Keytruda (pembrolizumab) patents. Retrieved from https://www.drugpatentwatch.com/drug/keytruda-pembrolizumab

Note: Patent expiration dates may be subject to change based on various factors, including new patents and regulatory actions.