RE:RE:RE:RE:AstraZeneca's ADC disappoints - on severe adverse eventsMarch 06, 2024 - Since U.K.’s National Institute for Health and Care Excellence (NICE) said Tuesday that it will not recommend the use of AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu (fam-trastuzumab deruxtecan-nxki) to treat patients with HER2-low breast cancer, it also follows that Enhertu will not be recommended for HER2-negative breast cancer, which represents 60% to 70% of the breast cancer market, leaving the market open for ONCY's pelareorep.
Since HER2-negative breast cancer is a cancer with an unmet medical treatment need, and ONCY's pelareorep has received fast track approval for the indication, the opportunity for FDA Accelerated Approval could be granted in quick succession with ONCY's expected announcement of the first Phase 3 patient being treated.
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