ALAMEDA, Calif.–(BUSINESS WIRE)–Sep 21, 2018–Exelixis, Inc. (NASDAQ:EXEL) today appear that its accomplice Ipsen accustomed a absolute assessment from the Board for Medicinal Articles for Human Use (CHMP), the accurate board of the European Medicines Agency (EMA), for CABOMETYX ® (cabozantinib) tablets as a monotherapy for the assay of hepatocellular blight (HCC) in adults who accept been ahead advised with sorafenib. The absolute CHMP assessment will now be advised by the European Commission, which has the ascendancy to accept medicines for the European Union.
“This absolute CHMP assessment represents cogent advance for patients in Europe with this advancing anatomy of alarmist blight who advance on above-mentioned systemic therapy, a ample underserved accommodating citizenry that currently alone has one accustomed second-line assay option,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “We are aflame about the abeyant ameliorative allowances CABOMETYX may activity the alarmist blight association and attending avant-garde to the European Commission’s decision.”
Under the agreement of the Accord Agreement with Ipsen, Exelixis is acceptable to accept a anniversary acquittal of $40 actor for the approval of the second-line assay of HCC. This anniversary would be paid by Ipsen aural 70 canicule of the approval accommodation by the European Commission.
CABOMETYX is currently accustomed in the European Union for the assay of avant-garde renal corpuscle blight (RCC) in adults who accept accustomed above-mentioned VEGF-targeted assay and for ahead basic intermediate- or poor-risk avant-garde RCC. The CHMP advocacy to aggrandize the adumbration is based on after-effects from the CELESTIAL balloon of CABOMETYX in patients with avant-garde HCC who accustomed above-mentioned sorafenib. In this appearance 3 cardinal trial, CABOMETYX accustomed a statistically cogent and clinically allusive advance in all-embracing adaptation (OS) against placebo.
On May 29, 2018, Exelixis appear that the U.S. Food and Biologic Administration (FDA) accustomed for filing the added New Biologic Appliance (sNDA) for CABOMETYX for ahead advised avant-garde HCC and assigned a Prescription Biologic User Fee Act (PDUFA) activity date of January 14, 2019. An sNDA is an appliance to the FDA that, if approved, will acquiesce a biologic sponsor to accomplish changes to a ahead accustomed artefact label, including modifications to the indication.
Please see Important Assurance Advice beneath and abounding U.S. prescribing advice at .
About the CELESTIAL Study
CELESTIAL is a randomized, double-blind, placebo-controlled abstraction of cabozantinib in patients with avant-garde HCC conducted at added than 100 sites globally in 19 countries. The balloon was advised to accept 760 patients with avant-garde HCC who accustomed above-mentioned sorafenib and may accept accustomed up to two above-mentioned systemic blight therapies for HCC and had able alarmist function. Enrollment of the balloon was completed in September 2017. Patients were randomized 2:1 to accept 60 mg of cabozantinib already circadian or placebo and were stratified based on assay of the ache (hepatitis C, hepatitis B or other), geographic arena (Asia against added regions) and attendance of extrahepatic advance and/or macrovascular aggression (yes or no). No cross-over was accustomed amid the abstraction accoutrements during the addled assay appearance of the trial. The primary endpoint for the balloon is OS, and accessory endpoints accommodate cold acknowledgment amount and PFS. Exploratory endpoints accommodate patient-reported outcomes, biomarkers and safety.
In October 2017, Exelixis appear that the absolute abstracts ecology board for the CELESTIAL abstraction recommended that the balloon be chock-full for adeptness afterward assay at the added planned acting ysis, with cabozantinib accouterment a statistically cogent and clinically allusive advance in OS compared with placebo in patients with ahead advised avant-garde HCC. The data, originally presented at the 2018 American Society of Analytic Oncology’s Gastrointestinal Cancers Symposium (ASCO-GI) in January 2018, were appear in The New England Journal of Medicine in July 2018. 1
Liver blight is the second-leading account of blight afterlife worldwide, accounting for added than 700,000 deaths and 800,000 new cases anniversary year. 2 In the U.S., the accident of alarmist blight has added than tripled back 1980. 3 HCC is the best accepted anatomy of alarmist cancer, authoritative up about three-fourths of the estimated about 42,000 new cases in the U.S. in 2018. 4 HCC is the fastest-rising account of cancer-related afterlife in U.S. 1 After treatment, patients with avant-garde HCC usually survive beneath than 6 months. 4
CABOMETYX tablets are accustomed in the United States for the assay of patients with avant-garde RCC. CABOMETYX tablets are additionally accustomed in: the European Union, Norway, Iceland, Australia, Switzerland and South Korea for the assay of avant-garde RCC in adults who accept accustomed above-mentioned VEGF-targeted therapy; in the European Union for ahead basic intermediate- or poor-risk avant-garde RCC; and in Canada for developed patients with avant-garde RCC who accept accustomed above-mentioned VEGF targeted therapy. In March 2017, the FDA accepted drop biologic appellation to cabozantinib for the assay of avant-garde HCC. On March 28, 2018, Ipsen appear that the European Medicines Agency accurate its appliance for a new adumbration for cabozantinib as a assay for ahead advised avant-garde HCC in the European Union; on September 20, 2018 the CHMP provided a absolute assessment for CABOMETYX as a monotherapy for the assay of HCC in adults who accept been ahead advised with sorafenib. In 2016, Exelixis accepted Ipsen absolute rights for the commercialization and added ytic development of cabozantinib alfresco of the United States and Japan. In 2017, Exelixis accepted absolute rights to Takeda Biologic Aggregation Limited for the commercialization and added ytic development of cabozantinib for all approaching break in Japan.
U.S. Important Assurance Information
Hemorrhage: Astringent and baleful hemorrhages accept occurred with CABOMETYX. In two RCC studies, the accident of Grade ≥ 3 hemorrhagic contest was 3% in CABOMETYX-treated patients. Do not administrate CABOMETYX to patients that accept or are at accident for astringent hemorrhage.Gastrointestinal (GI) Perforations and Fistulas: In RCC studies, fistulas were appear in 1% of CABOMETYX-treated patients. Baleful perforations occurred in patients advised with CABOMETYX. In RCC studies, gastrointestinal (GI) perforations were appear in 1% of CABOMETYX-treated patients. Monitor patients for affection of fistulas and perforations, including abscess and sepsis. Discontinue CABOMETYX in patients who acquaintance a fistula which cannot be appropriately managed or a GI perforation.Thrombotic Events: CABOMETYX assay after-effects in an added accident of thrombotic events. In RCC studies, venous thromboemism occurred in 9% (including 5% pulmonary emism) and arterial thromboemism occurred in 1% of CABOMETYX-treated patients. Baleful thrombotic contest occurred in the cabozantinib ytic program. Discontinue CABOMETYX in patients who advance an astute myocardial infarction or any added arterial thromboemic complication.Hypertension and Hypertensive Crisis: CABOMETYX assay after-effects in an added accident of treatment-emergent hypertension, including hypertensive crisis. In RCC studies, hypertension was appear in 44% (18% Grade ≥ 3) of CABOMETYX-treated patients. Monitor claret burden above-mentioned to admission and consistently during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not abundantly controlled with medical management; back controlled, resume CABOMETYX at a bargain dose. Discontinue CABOMETYX for astringent hypertension that cannot be controlled with anti-hypertensive therapy. Discontinue CABOMETYX if there is affirmation of hypertensive crisis or astringent hypertension admitting optimal medical management.Diarrhea: In RCC studies, diarrhea occurred in 74% of patients advised with CABOMETYX. Grade 3 diarrhea occurred in 11% of patients advised with CABOMETYX. Withhold CABOMETYX in patients who advance intolerable Grade 2 diarrhea or Grade 3-4 diarrhea that cannot be managed with accepted antidiarrheal treatments until advance to Grade 1; resume CABOMETYX at a bargain dose.Palmar-Plantar Erythrodysesthesia (PPE): In RCC studies, palmar-plantar erythrodysesthesia (PPE) occurred in 42% of patients advised with CABOMETYX. Grade 3 PPE occurred in 8% of patients advised with CABOMETYX. Withhold CABOMETYX in patients who advance intolerable Grade 2 PPE or Grade 3 PPE until advance to Grade 1; resume CABOMETYX at a bargain dose.Reversible Posterior Leukoencephalopathy Affection (RPLS), a affection of subcortical vasogenic edema diagnosed by appropriate award on MRI, occurred in the cabozantinib ytic program. Perform an appraisal for RPLS in any accommodating presenting with seizures, headache, beheld disturbances, abashing or adapted brainy function. Discontinue CABOMETYX in patients who advance RPLS.Embryo-fetal Toxicity may be associated with CABOMETYX. Advise abundant women of the abeyant accident to a fetus. Advise females of changeable abeyant to use able contraception during CABOMETYX assay and for 4 months afterwards the aftermost dose.Adverse Reactions: The best frequently appear (≥25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, hypertension, PPE, weight decreased, ing, dysgeusia, and stomatitis.Strong CYP3A4 Inhibitors: If accessory use with able CYP3A4 inhibitors cannot be avoided, abate the CABOMETYX dosage.Strong CYP3A4 Inducers: If accessory use with able CYP3A4 inducers cannot be avoided, access the CABOMETYX dosage.Lactation: Advise women not to feed while demography CABOMETYX and for 4 months afterwards the final dose.Hepatic Impairment: In patients with balmy to abstinent hepatic impairment, abate the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with astringent hepatic impairment.
Please see accompanying abounding Prescribing Information.
Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology aggregation that strives to advance the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Afterward aboriginal assignment in archetypal abiogenetic systems, we accustomed a ample biologic ysis and development belvedere that has served as the foundation for our connected efforts to accompany new blight therapies to patients in need. We apparent our three commercially accessible products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib) and COTELLIC® (cobimetinib), and accept entered into partnerships with arch biologic companies to accompany these important medicines to patients worldwide. Supported by revenues from our marketed articles and collaborations, we are committed to carefully reinvesting in our business to aerate the abeyant of our pipeline. We are addition our absolute ameliorative assets with targeted business development activities and centralized biologic ysis – all to bear the aing bearing of Exelixis medicines and advice patients balance stronger and alive longer. In July 2018, Exelixis was added to the Accepted & Poor’s (S&P) MidCap 400 index, which measures the achievement of assisting mid-sized companies. For added advice about Exelixis, amuse appointment www.exelixis.com, chase @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
Forward-Looking Statement Disclaimer
This columnist absolution contains avant-garde statements, including, after limitation, statements accompanying to: the authoritative assay action in the European Union; the ameliorative abeyant of CABOMETYX as a assay advantage for developed patients in the European Union with avant-garde HCC who accept been ahead advised with sorafenib; Exelixis’ accommodation to accept a $40 actor anniversary acquittal from Ipsen for the approval of CABOMETYX as a assay for ahead advised avant-garde HCC in the European Union, and the timing for cancellation of such payment; and Exelixis’ affairs to reinvest in its business to aerate the abeyant of the company’s pipeline, including through targeted business development activities and centralized biologic discovery. Any statements that accredit to expectations, projections or added characterizations of approaching contest or affairs are avant-garde statements and are based aloft Exelixis’ accepted plans, assumptions, beliefs, expectations, estimates and projections. Avant-garde statements absorb risks and uncertainties. Actual after-effects and the timing of contest could alter materially from those advancing in the avant-garde statements as a aftereffect of these risks and uncertainties, which include, after limitation: risks and uncertainties accompanying to authoritative assay and approval processes, including that the European Commission may not accept cabozantinib as a assay for ahead advised avant-garde HCC; abrupt apropos that may appear as a aftereffect of the accident of adverse assurance contest or added abstracts yses of ytic trials evaluating cabozantinib; Exelixis’ assurance on its relationships with its accord partners, including their following of authoritative approvals for cabozantinib in new break and their adherence to their obligations beneath accordant accord agreements; Exelixis’ adeptness to assure its bookish acreage rights; bazaar competition; changes in bread-and-er and business conditions; and added factors affecting the adeptness of Exelixis and its ally to access authoritative approval for cabozantinib in new break discussed beneath the explanation “Risk Factors” in Exelixis’ Quarterly Report on Anatomy 10-Q filed with the Securities and Exchange Commission (SEC) on August 1, 2018, and in Exelixis’ approaching filings with the SEC. All avant-garde statements in this columnist absolution are based on advice accessible to Exelixis as of the date of this columnist release, and Exelixis undertakes no obligation to amend or alter any avant-garde statements independent herein.
Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks.
1 Abou-Alfa, G, Meyer T, Cheng AL, et al. Cabozantinib in patients with avant-garde and advanced hepatocellular carcinoma. N Engl J Med. 2018. 379:54-63.
2 International Agency for Research on Cancer. GLOBOCAN 2018. Alarmist Fact Sheet. Accessible at: http://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf. Accessed September 2018.
3 American Blight Society: Blight Facts and Figures 2018. Accessible at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2018/cancer-facts-and-figures-2018.pdf. Accessed September 2018.
4 Weledji E, Orock G, Ngowe M, NsaghaD. How austere is hepatocellular carcinoma? Ann Med Surg. 2014. 3:71-76.
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Susan Hubbard, 650-837-8194
EVP, Public Affairs and
Lindsay Treadway, 650-837-7522
Senior Director, Public Affairs and
KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA
INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY ONCOLOGY PHARMACEUTICAL RESEARCH SCIENCE GENERAL HEALTH
SOURCE: Exelixis, Inc.
Copyright Business Wire 2018.
PUB: 09/21/2018 01:32 AM/DISC: 09/21/2018 01:32 AM
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