– Approved for Adult Patients with HER2-Positive Metastatic Breast Cancer Who Have Received at Least Two Prior Anti-HER2 Treatment Regimens –<\/i><\/p>\n
– First HER-2 Tyrosine Kinase Inhibitor Combination Regimen to Improve Overall and Progression-Free Survival in Previously Treated Patients with Metastatic HER2-Positive Breast Cancer With or Without Brain Metastases –<\/i><\/p>\n
BOTHELL, Wash.–(BUSINESS WIRE<\/a>)–Seagen Inc<\/a>. (Nasdaq:SGEN) today announced that the European Commission (EC) has granted marketing authorization for TUKYSA\u00ae<\/sup><\/b> (tucatinib) 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. TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.1,2<\/sup><\/p>\n \n\u201cThis approval is a significant advancement for patients in Europe, who will for the first time have an approved medicine demonstrating a survival benefit for HER2-positive metastatic breast cancer after disease progression following two standard anti-HER2 treatment regimens,\u201d said Prof. Dr. Med Volkmar Mueller, Deputy Director at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany and investigator for the pivotal trial. \u201cIn the HER2CLIMB pivotal trial, the tucatinib combination regimen improved overall and progression-free survival compared to trastuzumab and capecitabine alone, including in patients with active, untreated or progressing brain metastases, a population with significant unmet need.\u201d\n<\/p>\n \n\u201cThe TUKYSA combination is a landmark therapy for patients with HER2-positive metastatic breast cancer with or without brain metastases, extending overall survival in these patients after two prior anti-HER2 treatment regimens,\u201d said Clay Siegall, Ph.D., Chief Executive Officer at Seagen. \u201cWe are pleased TUKYSA is now approved in Europe, and we look forward to further collaborating with individual countries to ensure it is available to patients.\u201d\n<\/p>\n \nThe Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for TUKYSA in December 2020. The approval of TUKYSA is valid in all countries of the European Union, as well as Norway, Liechtenstein, Iceland and Northern Ireland.\n<\/p>\n HER2CLIMB Efficacy and Safety<\/b><\/p>\n \nPatients who received TUKYSA in combination with trastuzumab and capecitabine in the pivotal trial had a 46 percent reduction in the risk of cancer progression or death (PFS), the primary endpoint, compared to patients who received trastuzumab and capecitabine alone (hazard ratio (HR)=0.54 [95% Confidence Interval (CI): 0.42, 0.71]; p<0.00001) and improved overall survival with a reduction in the risk of death by 34 percent (HR=0.66 [95% CI: 0.50, 0.87]; p=0.0048). The most common adverse reactions occurring in 20 percent or more of patients who received TUKYSA were diarrhea, nausea, vomiting, stomatitis, AST increase, ALT increase, and rash.1<\/sup><\/p>\n \nThe pivotal trial, HER2CLIMB, is a randomized (2:1), double-blind, placebo-controlled, active comparator, global trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and trastuzumab emtansine (T-DM1 SmPC).\n<\/p>\n About HER2-Positive Breast Cancer<\/b><\/p>\n \nPatients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. In 2020, more than two million new cases of breast cancer were diagnosed worldwide, including 531,086 in Europe.3<\/sup> Between 15 and 20 percent of breast cancer cases are HER2-positive.4<\/sup> HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.4,5,6<\/sup> Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.7,8,9<\/sup><\/p>\n About TUKYSA (tucatinib)<\/b><\/p>\n \nTUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.\n<\/p>\n U.S. Important Safety Information<\/b><\/p>\n Warnings and Precautions<\/b><\/p>\n If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.\n<\/li>\n<\/ul>\n Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatotoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.\n<\/li>\n<\/ul>\n Adverse Reactions<\/b><\/p>\n \nSerious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in \u22652% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.\n<\/p>\n \nAdverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in \u22651% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in \u22652% of patients were hepatotoxicity (8%) and diarrhea (6%).\n<\/p>\n \nThe most common adverse reactions in patients who received TUKYSA (\u226520%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.\n<\/p>\n Lab Abnormalities<\/b><\/p>\n \nIn HER2CLIMB, Grade \u22653 laboratory abnormalities reported in \u22655% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.\n<\/p>\n Drug Interactions<\/b><\/p>\n Use in Specific Populations<\/b><\/p>\n For more information, please see the full Prescribing Information for TUKYSA here<\/a>.<\/b><\/p>\n About Seagen<\/b><\/p>\n \nSeagen is a global biotechnology company that discovers, develops, and commercializes transformative cancer medicines to make a meaningful difference in people\u2019s lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland, and the European Union. For more information on the company\u2019s marketed products and robust pipeline, visit www.seagen.com<\/a> and follow @SeagenGlobal<\/a> on Twitter.\n<\/p>\n Forward-Looking Statements<\/b><\/p>\n \nCertain statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of TUKYSA including its efficacy, safety and therapeutic uses, and the potential to make TUKYSA available to patients in Europe. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the possibilities that we may experience delays or setbacks in seeking pricing and reimbursement approvals or otherwise in commercializing TUKYSA in Europe; that adverse events or safety signals may occur; and that adverse regulatory actions may occur. More information about the risks and uncertainties faced by Seagen is contained under the caption \u201cRisk Factors\u201d included in the company\u2019s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and the company\u2019s Current Report on Form 8-K dated December 30, 2020 filed with the U.S. Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.\n<\/p>\n\n
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