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`FDA approves Tykerb (lapatinib) in
`combination with Xeloda (capecitabine)
`for the treatment of advanced or
`metastatic breast cancer in women who
`have progressed on prior therapy
`
`27 August 2008
`This press release is intended for business journalists and analysts/investors. Please
`note that this release may not have been issued in every market in which GSK
`operates.
`
`GlaxoSmithKline’s bew breast cancer drug may give women more options
`
`PHILADELPHIA, PA, March 13, 2007 — GlaxoSmithKline plc [NYSE: GSK, LSE:
`GSK] announced today that the United States Food and Drug Administration (FDA)
`®
`®
`approved TYKERB (lapatinib), in combination with Xeloda (capecitabine), for the
`treatment of patients with advanced or metastatic breast cancer whose tumors
`overexpress HER2 and who have received prior therapy including an anthracycline, a
`taxane, and trastuzumab. It is the first targeted, oncedaily oral treatment option for
`this patient population. TYKERB was granted Priority Review by the FDA in
`November 2006.
`
`"Tykerb is a significant breakthrough for women with advanced HER2 (ErbB2)
`positive breast cancer. The data clearly show that this small molecule, oral, targeted
`agent, in combination with capecitabine, is effective for women whose disease has
`progressed on previous therapies, including anthracyclines, taxanes and
`trastuzumab," said Paolo Paoletti, MD, Senior Vice President of the Oncology
`Medicine Development Center at GSK. "The approval of TYKERB demonstrates our
`R&D organization’s strong commitment to the discovery and development of novel
`cancer treatments. We are dedicated to the further study and development of Tykerb
`in a variety of settings including adjuvant breast cancer as well as in other solid tumor
`
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`IMMUNOGEN 2218, pg. 1
`Phigenix v. Immunogen
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`12/18/2014 FDA approves Tykerb (lapatinib) in combination with Xeloda (capecitabine) for the treatment of advanced or metastatic breast cancer in women who have …
`types.”
`
`This approval reflects more than 16 years of research, including more than 60 clinical
`trials and investigatorinitiated collaborative research studies. TYKERB inhibits two
`validated targets in oncology, the kinase components of the EGFR (ErbB1) and HER2
`(ErbB2) receptors, commonly associated with cancer cell proliferation and tumor
`growth. As a targeted therapy, TYKERB is designed to interfere with discrete cellular
`processes or disease mechanisms prevalent in cancer. TYKERB will be available in
`the United States within two weeks and, as an oral therapy, offers added convenience
`for patients.
`
`“The approval of TYKERB is an important milestone in our commitment to become a
`major oncology company that focuses on scientific innovation and genuine patient
`needs,” said Chris Viehbacher, President, US Pharmaceuticals at GSK. “Our rich
`pipeline of oncology medicines underscores our commitment to cancer patients. This
`commitment extends to programs to help ensure that women who may benefit from
`TYKERB will have access to it."
`
`TYKERB Patient Support
`
`To support patient access, GSK has established a single source for information and
`support called Tykerb CARES. Through this comprehensive program,
`®
`knowledgeable consultants are available to answer productrelated questions from
`patients and physicians, and can assist them with obtaining TYKERB. Additionally,
`Tykerb CARES reimbursement counselors will help patients understand their
`®
`insurance coverage and, if appropriate, assist in identifying alternative financial
`support. More information regarding Tykerb CARES can be found by calling 1866
`®
`4TYKERB (895372). Program hours are Monday — Friday, 8:30 am — 8:00 pm ET.
`
`TYKERB Clinical Results
`
`This approval was based on the pivotal Phase III trial of 399 patients which showed
`that the median time to disease progression as assessed by independent reviewers
`was 27.1 weeks on the combination of TYKERB and capecitabine versus 18.6 weeks
`on capecitabine alone in women with advanced or metastatic HER2 (ErbB2) positive
`breast cancer whose disease had progressed following treatment with trastuzumab
`and other cancer therapies. The hazard ratio of 0.57 (95% CI: 0.43, 0.77, p =
`
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`IMMUNOGEN 2218, pg. 2
`Phigenix v. Immunogen
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`12/18/2014 FDA approves Tykerb (lapatinib) in combination with Xeloda (capecitabine) for the treatment of advanced or metastatic breast cancer in women who have …
`0.00013) represents a 43 percent reduction in the risk of progression for the patients
`1
`on the combination arm. Differences between treatment groups based on unblinded
`investigator assessments were smaller but continued to be clinically and statistically
`significant.
`
`Adverse events (AEs) leading to discontinuation were similar in the TYKERB
`capecitabine combination arm (14 percent) versus capecitabine alone (14 percent).
`Most commonly reported AEs in the TYKERBcapecitabine combination arm included
`diarrhea, handfoot syndrome, nausea, rash, vomiting and fatigue. Left ventricular
`ejection fraction (LVEF), a measure of the strength of the heart’s pumping capacity,
`was monitored during the study. Among 198 patients who received the TYKERB
`capecitabine combination treatment, three experienced an asymptomatic (grade 2)
`decrease in LVEF and one experienced a symptomatic (grade 3) decrease in LVEF.
`
`Ongoing Trials
`
`GSK has a comprehensive clinical program that is actively studying TYKERB in other
`breast cancer settings and other cancers to better identify patient populations that
`may respond to TYKERB.
`
`Marketing applications for lapatinib (TYKERB/TYVERB) have been filed around the
`world, including the European Union, Switzerland, Canada, Brazil, Australia, and
`South Korea.
`
`About Tykerb
`
`TYKERB, a small molecule that is administered orally, inhibits the tyrosine kinase
`components of the EGFR (ErbB1) and HER2 (ErbB2) receptors. Stimulation of EGFR
`(ErbB1) and HER2 (ErbB2) is associated with cell proliferation and with multiple
`processes involved in tumor progression, invasion, and metastases. Overexpression
`of these receptors has been reported in a variety of human tumors and is associated
`with poor prognosis and reduced overall survival.
`
`About GlaxoSmithKline
`
`GlaxoSmithKline — one of the world's leading researchbased pharmaceutical and
`healthcare companies — is committed to improving the quality of human life by
`enabling people to do more, feel better, and live longer. For company information, visit
`
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`IMMUNOGEN 2218, pg. 3
`Phigenix v. Immunogen
`IPR2014-00676
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`12/18/2014 FDA approves Tykerb (lapatinib) in combination with Xeloda (capecitabine) for the treatment of advanced or metastatic breast cancer in women who have …
`GlaxoSmithKline at http://www.gsk.com.
`
`Cautionary statement regarding forwardlooking statements
`
`Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act
`of 1995, the company cautions investors that any forwardlooking statements or
`projections made by the company, including those made in this announcement, are
`subject to risks and uncertainties that may cause actual results to differ materially
`from those projected. Factors that may affect the Group's operations are described
`under ''Risk Factors'' in the Operating and Financial Review and Prospects in the
`company's Annual Report on Form 20F for 2005.
`
`Notes to editors:
`
`®
`TYKERB is a registered trademark of the GlaxoSmithKline group of companies in the
`United States.
`
`TYVERB® is a registered trademark of the GlaxoSmithKline group of companies in
`Europe and is the proposed trade name in certain markets, pending regulatory
`approval.
`
`®
`Herceptin is a registered trademark of Genentech, Inc. in the U.S.and Roche
`Pharmaceuticals in Europe.
`
`®
`Xeloda is a registered trademark of Roche Pharmaceuticals.
`
`To access the latest GSK Oncology media materials, visit http://www.gsk.com/media
`or http://www.gskcancermedia.com
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`IMMUNOGEN 2218, pg. 4
`Phigenix v. Immunogen
`IPR2014-00676
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`
`
`12/18/2014 FDA approves Tykerb (lapatinib) in combination with Xeloda (capecitabine) for the treatment of advanced or metastatic breast cancer in women who have …
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`References
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`1.
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`Data on file, GlaxoSmithKline, King of Prussia.
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`IMMUNOGEN 2218, pg. 5
`Phigenix v. Immunogen
`IPR2014-00676
`
`
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`12/18/2014 FDA approves Tykerb (lapatinib) in combination with Xeloda (capecitabine) for the treatment of advanced or metastatic breast cancer in women who have …
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`IMMUNOGEN 2218, pg. 6
`Phigenix v. Immunogen
`IPR2014-00676
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