Seattle Genetics Announces the Approval of TUKYSA (tucatinib) in Switzerland for the Treatment of Patients with Metastatic HER2-Positive Breast Cancer…
Posted: May 12, 2020 at 12:56 pm
BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc., Inc. (Nasdaq:SGEN) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted approval for TUKYSA (tucatinib) tablets in combination with trastuzumab and capecitabine, for the treatment of patients with metastatic HER2-positive breast cancer, who have previously received two or more anti-HER2 regimens in any setting, including trastuzumab, pertuzumab and trastuzumab-emtansine (TDM1).
The application for TUKYSA approval was reviewed by Swissmedic as part of Project Orbis, an initiative of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international regulatory agencies in Canada, Australia and Singapore. On April 17, the FDA approved TUKYSA in the U.S. under the FDAs Real-Time Oncology Review (RTOR) pilot program, four months prior to its action date, and represented the first new drug approved under Project Orbis.
Were grateful to Swissmedic for their collaboration through FDAs Project Orbis in approving this important new medicine in Switzerland, said Jennifer Stephens, Vice President of Regulatory Affairs at Seattle Genetics. We're committed to bringing new targeted therapies to patients, and we are excited about this important first step toward making TUKYSA available to patients in Switzerland.
TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.i,ii
The approval is based on results from the pivotal trial HER2CLIMB, a randomized (2:1), double-blind, placebo-controlled 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 ado-trastuzumab emtansine (T-DM1). The study results were published in The New England Journal of Medicine in December 2019.
About HER2-Positive Breast Cancer
Patients 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 2018, more than two million new cases of breast cancer were diagnosed worldwide, including 522,513 in Europe. iii Between 15 and 20 percent of breast cancer cases are HER2-positive.iv Historically, HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.v,vi,vii Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.viii,ix,x
About TUKYSA (tucatinib)
TUKYSA 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.xi In the U.S., TUKYSA is approved in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
Important U.S. Safety Information
Warnings and Precautions
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.
Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
Adverse Reactions
Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in 2% 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.
Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in 1% 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 2% of patients were hepatotoxicity (8%) and diarrhea (6%).
The most common adverse reactions in patients who received TUKYSA (20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.
Lab Abnormalities
In HER2CLIMB, Grade 3 laboratory abnormalities reported in 5% 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.
Drug Interactions
Use in Specific Populations
For more information, please see the full Prescribing Information for TUKYSA here.
About Seattle Genetics
Seattle Genetics, Inc. is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in peoples lives. ADCETRIS (brentuximab vedotin) and PADCEVTM (enfortumab vedotin-ejfv) use the companys industry-leading antibody-drug conjugate (ADC) technology. ADCETRIS is approved in certain CD30-expressing lymphomas, and PADCEV is approved in certain metastatic urothelial cancers. TUKYSATM (tucatinib), a small molecule tyrosine kinase inhibitor, is approved in certain HER2-positive metastatic breast cancers. The company is headquartered in Bothell, Washington, with locations in California, Switzerland and the European Union. For more information on our robust pipeline, visit http://www.seattlegenetics.com and follow @SeattleGenetics on Twitter.
Forward Looking Statements
Certain 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 including the potential use of TUKYSA in combination with trastuzumab and capecitabine for the treatment of patients with metastatic HER2-positive breast cancer, who have previously received two or more anti-HER2 regimens in any setting, including trastuzumab, pertuzumab and trastuzumab-emtansine (TDM1) and the potential to bring TUKYSA to patients in Switzerland. 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 reimbursement processes, the extent of reimbursement, the possibility that adverse events or safety signals may occur, the possibility that the ultimate utilization and adoption of TUKYSA by prescribing physicians may be limited, including due to impacts related to the COVID-19 pandemic, the possibility of difficulties in supplying and commercializing a new therapeutic agent, and the possibility of adverse regulatory actions. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors included in the companys Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 filed with the Securities and Exchange Commission. Seattle Genetics 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.
i TUKYSA [package insert]. Bothell, WA: Seattle Genetics, Inc.ii Anita Kulukian, Patrice Lee, Janelle Taylor, et al. Preclinical Activity of HER2-Selective Tyrosine Kinase Inhibitor Tucatinib as a Single Agent or in Combination with Trastuzumab or Docetaxel in Solid Tumor ModelsMol Cancer Ther 2020;19:976-987.iii Breast. Globocan 2018. World Health Organization. 2019. https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf iv Slamon D, Clark G, Wong S, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987; 235(4785): 177-82.v Loibli S, Gianni L. HER2-positive breast cancer. Lancet. 2017; 389(10087): 2415-29.vi Slamon D, Clark G, Wong S, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987; 235(4785): 177-82.vii Breast Cancer HER2 Status. American Cancer Society website. http://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-her2-status.html. Accessed March 9, 2020.viii Freedman RA, Gelman RS, Anders CK, et al. TBCRC 022: a phase II trial of neratinib and capecitabine for patients with human epidermal growth factor receptor 2-positive breast cancer and brain metastases. J Clin Oncol. 2019;37:1081-1089.ix Olson EM, Najita JS, Sohl J, et al. Clinical outcomes and treatment practice patterns of patients with HER2-positive metastatic breast cancer in the post-trastuzumab era. Breast. 2013;22:525-531.x Bendell JC, Domchek SM, Burstein HJ, et al. Central nervous system metastases in women who receive trastuzumab-based therapy for metastatic breast carcinoma. Cancer. 2003;97:2972-2977.xi TUKYSA [package insert]. Bothell, WA: Seattle Genetics, Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200512005217/en/
Here is the original post:
Seattle Genetics Announces the Approval of TUKYSA (tucatinib) in Switzerland for the Treatment of Patients with Metastatic HER2-Positive Breast Cancer...
- Definition Of female reproductive system |Genetic ... [Last Updated On: May 4th, 2015] [Originally Added On: May 4th, 2015]
- Female - Wikipedia, the free encyclopedia [Last Updated On: May 4th, 2015] [Originally Added On: May 4th, 2015]
- Impact of Genetic Selection on Female Fertility - eXtension [Last Updated On: May 21st, 2015] [Originally Added On: May 21st, 2015]
- X chromosome - Genetics Home Reference [Last Updated On: May 31st, 2015] [Originally Added On: May 31st, 2015]
- How Chromosomes Determine Sex - About [Last Updated On: May 31st, 2015] [Originally Added On: May 31st, 2015]
- Galaxy Of Genetic Differences Between Men & Women [Last Updated On: June 10th, 2015] [Originally Added On: June 10th, 2015]
- Difference between Male and Female Chromosomes [Last Updated On: July 3rd, 2015] [Originally Added On: July 3rd, 2015]
- Female Age and Chromosome Problems in Eggs and Embryos [Last Updated On: July 10th, 2015] [Originally Added On: July 10th, 2015]
- Pathology and Genetics of Tumours of the Breast and Female ... [Last Updated On: July 14th, 2015] [Originally Added On: July 14th, 2015]
- Sex - Wikipedia, the free encyclopedia [Last Updated On: July 14th, 2015] [Originally Added On: July 14th, 2015]
- Sexual differentiation - Wikipedia, the free encyclopedia [Last Updated On: July 24th, 2015] [Originally Added On: July 24th, 2015]
- XY sex-determination system - Wikipedia, the free encyclopedia [Last Updated On: July 24th, 2015] [Originally Added On: July 24th, 2015]
- The Female Form: Embrace Your Genetics and Find Beauty in ... [Last Updated On: August 21st, 2015] [Originally Added On: August 21st, 2015]
- Female Hereditary Hair Loss Treatment & Genetic Testing ... [Last Updated On: August 28th, 2015] [Originally Added On: August 28th, 2015]
- Female Infertility Genetic Causes | RSC New Jersey [Last Updated On: September 19th, 2015] [Originally Added On: September 19th, 2015]
- Spectacular Genetic Anomaly Results in Butterflies with ... [Last Updated On: September 24th, 2015] [Originally Added On: September 24th, 2015]
- Tortoiseshell cat - Wikipedia, the free encyclopedia [Last Updated On: September 25th, 2015] [Originally Added On: September 25th, 2015]
- The Genetics of Calico Cats - Department of Biology [Last Updated On: September 25th, 2015] [Originally Added On: September 25th, 2015]
- Human Genetics - Mendelian Inheritance 5 [Last Updated On: February 9th, 2016] [Originally Added On: February 9th, 2016]
- Androgenetic alopecia - Genetics Home Reference [Last Updated On: February 9th, 2016] [Originally Added On: February 9th, 2016]
- X chromosome - Wikipedia, the free encyclopedia [Last Updated On: February 23rd, 2016] [Originally Added On: February 23rd, 2016]
- Davis Angus Foss, Oklahoma [Last Updated On: March 2nd, 2016] [Originally Added On: March 2nd, 2016]
- Y chromosome - Wikipedia, the free encyclopedia [Last Updated On: March 10th, 2016] [Originally Added On: March 10th, 2016]
- Molecular Genetics Laboratory of Female Reproductive Cancer [Last Updated On: May 20th, 2016] [Originally Added On: May 20th, 2016]
- Genetics and Inheritance - National Fragile X Foundation [Last Updated On: May 25th, 2016] [Originally Added On: May 25th, 2016]
- Genetics - X Linked Problems - The Biology Corner [Last Updated On: June 2nd, 2016] [Originally Added On: June 2nd, 2016]
- Nicole Kush Female Cannabis Seeds by DNA Genetics and ... [Last Updated On: July 24th, 2016] [Originally Added On: July 24th, 2016]
- A gay Gene - Is Homosexuality Inherited Assault On Gay ... [Last Updated On: August 7th, 2016] [Originally Added On: August 7th, 2016]
- Cat coat genetics - Wikipedia, the free encyclopedia [Last Updated On: August 24th, 2016] [Originally Added On: August 24th, 2016]
- Cloning - Learn Genetics [Last Updated On: August 24th, 2016] [Originally Added On: August 24th, 2016]
- Homosexuality - Conservapedia [Last Updated On: September 21st, 2016] [Originally Added On: September 21st, 2016]
- Science & Health, Colleges Around Cincinnati, University ... [Last Updated On: September 23rd, 2016] [Originally Added On: September 23rd, 2016]
- Elephant - Wikipedia, the free encyclopedia [Last Updated On: September 28th, 2016] [Originally Added On: September 28th, 2016]
- Supercourse: Epidemiology, the Internet, and Global Health [Last Updated On: October 7th, 2016] [Originally Added On: October 7th, 2016]
- Glossary - PBS: Public Broadcasting Service [Last Updated On: October 17th, 2016] [Originally Added On: October 17th, 2016]
- Male - Wikipedia [Last Updated On: October 30th, 2016] [Originally Added On: October 30th, 2016]
- Female - Wikipedia [Last Updated On: October 30th, 2016] [Originally Added On: October 30th, 2016]
- Mount Sinai Health System - New York City | Mount Sinai ... [Last Updated On: November 5th, 2016] [Originally Added On: November 5th, 2016]
- Calico cat - Wikipedia [Last Updated On: November 23rd, 2016] [Originally Added On: November 23rd, 2016]
- Mosaic (genetics) - Simple English Wikipedia, the free ... [Last Updated On: November 25th, 2016] [Originally Added On: November 25th, 2016]
- Calico Cats - TheCatSite.com Community [Last Updated On: November 30th, 2016] [Originally Added On: November 30th, 2016]
- Physical attractiveness - Wikipedia [Last Updated On: December 16th, 2016] [Originally Added On: December 16th, 2016]
- XY sex-determination system - Wikipedia [Last Updated On: January 27th, 2017] [Originally Added On: January 27th, 2017]
- Triple X syndrome - Wikipedia [Last Updated On: February 3rd, 2017] [Originally Added On: February 3rd, 2017]
- How African Americans Use DNA Testing to Connect With Their Past - The Atlantic [Last Updated On: July 1st, 2017] [Originally Added On: July 1st, 2017]
- Hughes benefit from Wagyu fertility and eating quality - Queensland Country Life [Last Updated On: July 1st, 2017] [Originally Added On: July 1st, 2017]
- Genetics Research Update - Island Eye News [Last Updated On: July 1st, 2017] [Originally Added On: July 1st, 2017]
- DNA From Sperm Of Ex Partners Lingers In Female Flies And ... [Last Updated On: July 1st, 2017] [Originally Added On: July 1st, 2017]
- Federal officials to review endangered status of Florida panther - Tampabay.com [Last Updated On: July 4th, 2017] [Originally Added On: July 4th, 2017]
- Why Women Have Stronger Immune Systems than Men [Last Updated On: July 4th, 2017] [Originally Added On: July 4th, 2017]
- Why does it seem like nobody cares about female concussions? - ESPN [Last Updated On: July 8th, 2017] [Originally Added On: July 8th, 2017]
- Geneticist says Florida panther still deserves endangered species protection - Tampabay.com [Last Updated On: July 8th, 2017] [Originally Added On: July 8th, 2017]
- How the living world was changed, by the woman who changed it - New Scientist [Last Updated On: July 8th, 2017] [Originally Added On: July 8th, 2017]
- Sharks could hold genetic secret to long life: Study - The Hindu [Last Updated On: July 8th, 2017] [Originally Added On: July 8th, 2017]
- Weekly genetics review: Registrations on the up for most beef breeds - Beef Central [Last Updated On: July 12th, 2017] [Originally Added On: July 12th, 2017]
- Orphan Black Science Recap: Guillotines Decide - The Mary Sue [Last Updated On: August 2nd, 2017] [Originally Added On: August 2nd, 2017]
- Genetics honour to CQ Brahman breeder Alf Collins - Beef Central [Last Updated On: August 2nd, 2017] [Originally Added On: August 2nd, 2017]
- Elad Gil and Silicon Valley's bright future in cryptocurrency, genetics and health tech - TechCrunch [Last Updated On: August 2nd, 2017] [Originally Added On: August 2nd, 2017]
- Top 6 myths about heart disease debunked - AsiaOne [Last Updated On: August 6th, 2017] [Originally Added On: August 6th, 2017]
- About a new pest: the bagrada bug - Santa Fe New Mexican [Last Updated On: August 6th, 2017] [Originally Added On: August 6th, 2017]
- Researchers Prepare to Explore the Genetics of Gender Identity, With Caution - The Wire [Last Updated On: August 6th, 2017] [Originally Added On: August 6th, 2017]
- Embryo editing 'corrects' genetic heart condition - The Guam Daily Post [Last Updated On: August 6th, 2017] [Originally Added On: August 6th, 2017]
- Cycling and gender: how and why male and female cyclists need to train differently - Cycling Weekly [Last Updated On: August 6th, 2017] [Originally Added On: August 6th, 2017]
- First human embryo editing experiment in US 'corrects' gene for heart condition - Washington Post [Last Updated On: August 6th, 2017] [Originally Added On: August 6th, 2017]
- Researchers Explore the Science of Gender Identity - NBCNews.com [Last Updated On: August 7th, 2017] [Originally Added On: August 7th, 2017]
- Selecting at negative 9 months - High Plains Journal [Last Updated On: August 7th, 2017] [Originally Added On: August 7th, 2017]
- Google Manifesto: Does Biology Explain Gender Disparities in Tech? - Live Science [Last Updated On: August 10th, 2017] [Originally Added On: August 10th, 2017]
- Damore Has Science On His Side - The American Conservative [Last Updated On: August 10th, 2017] [Originally Added On: August 10th, 2017]
- Memo to all tech bros: Sexism, not biology, holds women back - New Scientist [Last Updated On: August 10th, 2017] [Originally Added On: August 10th, 2017]
- Genetic strategies to reduce gilt feed and development costs - National Hog Farmer [Last Updated On: August 10th, 2017] [Originally Added On: August 10th, 2017]
- Dewmar International BMC, Inc. (DEWM) Announces Investment in New West Genetics, Better Than Expected Progress ... - Benzinga [Last Updated On: August 11th, 2017] [Originally Added On: August 11th, 2017]
- No, the Google manifesto isn't sexist or anti-diversity. It's science - The Globe and Mail [Last Updated On: August 11th, 2017] [Originally Added On: August 11th, 2017]
- Couples can tailor-make their babies - Khaleej Times [Last Updated On: August 11th, 2017] [Originally Added On: August 11th, 2017]
- Sarah Bush Lincoln receives the 2017 Women's Choice Award - Journal Gazette and Times-Courier [Last Updated On: August 11th, 2017] [Originally Added On: August 11th, 2017]
- A major blind spot in animal testing is endangering the lives of women - Quartz [Last Updated On: August 11th, 2017] [Originally Added On: August 11th, 2017]
- Jonathan Hoffman: Pima County should butt out of medical decisions - Arizona Daily Star [Last Updated On: August 14th, 2017] [Originally Added On: August 14th, 2017]
- Trans athletes should be able to compete in gender they identify with: centre for ethics in sport - CBC.ca [Last Updated On: August 14th, 2017] [Originally Added On: August 14th, 2017]
- Orphan Black Was Never About Cloning - Slate Magazine [Last Updated On: August 14th, 2017] [Originally Added On: August 14th, 2017]
- Techly Explains: Are twins genetic? - Techly [Last Updated On: August 14th, 2017] [Originally Added On: August 14th, 2017]
- How technology can deliver freedom from the male calf - The Indian Express [Last Updated On: August 15th, 2017] [Originally Added On: August 15th, 2017]