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Pfizer Unit's Tukysa Receives Positive Opinion from EU Panel for New Indication

MT Newswires·10/16/2026 08:43:39
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08:43 AM EDT, 10/16/2026 (MT Newswires) -- Pfizer (PFE.F) unit Pfizer Europe received a positive opinion from a European Medicines Agency committee on a proposed change in the indications of HER2-positive breast cancer drug Tukysa. The recommendation covers the use of Tukysa, in combination with trastuzumab and pertuzumab, for the maintenance treatment of adult patients with unresectable or metastatic HER2-positive breast cancer following first-line chemotherapy, according to a Friday note. Tukysa was previously approved, in combination with trastuzumab and capecitabine, for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens. The indication changes are subject to final approval from the European Commission.