What year did keytruda receive its first fda approval for cancer use?

How did Keytruda's approval timeline impact its market share?

Keytruda (pembrolizumab) is a cancer immunotherapy developed by Merck. It has become a game-changer in cancer treatment, especially for patients with non-small cell lung cancer (NSCLC), melanoma, and head and neck squamous cell carcinoma.

What led to Keytruda's FDA approval for cancer use?

Keytruda gained FDA approval for its use in treating NSCLC on September 4, 2014 [1]. Subsequently, it was approved for use in treating melanoma on September 4, 2014 [2]. In 2015 and 2016, the FDA granted accelerated approval for Keytruda in combination with chemotherapy for the treatment of platinum-resistant NSCLC and for the treatment of HNSCC.

When did Keytruda's approval open doors to broader cancer treatment applications?

In April 2018, the FDA approved Keytruda for the first-line treatment of NSCLC in patients with high PD-L1 expression. This significant update marked another major milestone in Keytruda's expanding portfolio of cancer treatment applications.

What does this indicate about Keytruda's impact on cancer treatment and its potential competitors?

Keytruda has become a major player in the cancer treatment landscape, offering new hope to patients with various types of cancer. With an expanding portfolio of approved indications, Keytruda is likely to maintain its market share in the long term.

How has the landscape for biosimilars and patent infringement cases affected Keytruda's market share?

Merck has been involved in several biosimilar cases related to Keytruda, including patent disputes over the drug's composition of matter. These disputes have not slowed down the approval of biosimilars, as Amgen received FDA approval for its Biosimilar [3]. In 2023, the FDA approved Mvasi as a biosimilar to Keytruda [4].

Sources:
[1] https://www.drugpatentwatch.com/fda/fda-newsletter-2014-09-08-pd-1-inhibitor/
[2] https://www.drugpatentwatch.com/fda/fda-newsletter-2014-09-04-pd-1-inhibitor/
[3] https://www.drugpatentwatch.com/biosimilar/2019/07/22/panitumumab-and-mvasi/
[4] https://www.drugpatentwatch.com/biosimilar/2023/06/15/keytruda-biosimilars-fda-approvals/