AstraZeneca said on Thursday it had given up on the idea of seeking an early approval of its immunotherapy drug durvalumab in head and neck cancer using mid-stage Phase II clinical trials data.
The move follows recent changes in the competitive landscape, which has seen Merck’s similar Keytruda approved for the condition, reducing the case for special regulatory treatment of durvalumab.
The decision to drop early filing plans in head and neck cancer follows a similar outcome in lung cancer, where AstraZeneca was also too late because Keytruda and Bristol-Myers Squibb’s Opdivo had already won approval.
The drugmaker’s main hopes for durvalumab, however, are unaffected, since its big potential lies in helping previously untreated lung cancer patients, where it has shown promise when given as part of a combination therapy.
(Reporting by Ben Hirschler; editing by Jason Neely)
[“source-ndtv”]
