FDA Approves Tukysa for Advanced HER2-positive Breast Cancer

FDA Approves Tukysa for Advanced HER2-positive Breast Cancer
Seattle Genetics’ Tukysa (tucatinib) can now be used in combination with trastuzumab and Xeloda (capecitabine) to treat people with metastatic or inoperable HER2-positive breast cancer following its approval by the U.S. Food and Drug Administration (FDA).  This will help patients with or without brain metastases who have received one or more prior treatments with HER2-targeted therapies, such as Kadcycla (ado-trastuzumab emtansine), Perjeta (pertuzumab), and trastuzumab (sold under the brand name Herceptin, among others). “We’re pleased to have collaborated with the FDA on our second expedited real-time oncology review, enabling us to rapidly bring this new targeted medicine to patients,” Clay Siegall, PhD, CEO of Seattle Genetics, said in a company press release. “Tukysa has shown impressive results in people with HER2-positive metastatic breast cancer, including in patients with active brain metastases, and offers patients an effective medicine following previous treatment with other anti-HER2 agents in the metastatic setting.” For Tukysa’s approval, which was granted priority review in February, the FDA conducted the review under the Real-Time Oncology Review Pilot Program and Project Orbis.  The pilot program is aimed at bringing safe and effective treatments to patients as early as possible by making the review process more efficient. Project Orbis facilitates a collaborative process with international regulators allowing the simultaneous submission and review of cancer treatments, which may enable patients to receive earlier access in countries with regulatory submission delays.  For this review, the FDA collaborated with Health Canada, the Australian Therapeutic Goods Administration, Switzerland's Swissmedic, and Singapore's Health
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