In-depth analysis of key marketed drugs for SCCHN in the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK), including new clinical data and a comparative evaluation of clinical and commercial drug attributes to determine competitiveness in the marketplace.
Erbitux's dominant position as the leading targeted therapy for SCCHN is being challenged following the recent approvals of Keytruda and Opdivo. Furthermore, the head and neck cancer pipeline is highly active, with many late-stage candidates and potential competitors.
The blockbuster success of Erbitux in head and neck cancer makes it an attractive target for companies looking to develop cetuximab biosimilars. However, cetuximab biosimilars are not likely to launch until 2021 due to the lack of late-stage biosimilar candidates.
Keytruda was the first immunotherapy to be approved for head and neck cancer; however, the drug's failure in the confirmatory KEYNOTE-040 trial threatens the status of its accelerated approval. This trial failure could push physicians to preferentially prescribe other immunotherapies in place of Keytruda due to a loss of confidence in the drug.
Although Opdivo was the second immunotherapy to gain US regulatory approval, it was the first to gain full regulatory approval for head and neck cancer in the US based on positive Phase III data, and it was the first immunotherapy to gain approval for this indication in Japan and the EU. Opdivo is also being developed for use in combination with Yervoy for the lucrative first-line setting.
Key Topics Covered:
- Executive Summary
- Product Overview
- Product profile: Erbitux
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