Pierre Fabre receives positive CHMP opinion for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) in adult patients with advanced BRAF-mutant melanoma
Pierre Fabre today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) in combination for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. This opinion is based on data from the Phase 3 COLUMBUS trial.1 The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). The decision will be applicable to all 28 EU member states plus Liechtenstein, Iceland and Norway.
"We are delighted to be one step closer to bringing BRAFTOVI and MEKTOVI to patients with advanced BRAF-mutant melanoma in Europe,” said Frédéric Duchesne, President & CEO of the Pierre Fabre Pharmaceuticals Division. “If the European Commission approves BRAFTOVI and MEKTOVI, this will be a new treatment option for these patients who currently have a challenging prognosis.”
The CHMP positive opinion is based on results from the Phase 3 COLUMBUS trial, which demonstrated that the combination improved median progression-free survival (PFS), compared with vemurafenib alone (14.9 months versus 7.3 months, respectively: hazard ratio [HR] 0.54, 95% confidence interval [CI] 0.41–0.71; p<0.0001).1 As presented at the American Society of Clinical Oncology (ASCO) in June 2018, treatment with BRAFTOVI and MEKTOVI achieved a median overall survival (OS) of 33.6 months, compared with 16.9 months for patients treated with vemurafenib as a monotherapy (HR 0.61, 95% CI, 0.47–0.79; p<0.0001) in the planned analysis of OS in the COLUMBUS trial.2 Adverse events leading to discontinuation that were suspected to be related to the study treatment occurred in 6% of patients.1 The most common Grade 3–4 adverse events, seen in more than 5% of patients, were: increased gamma-glutamyltransferase (9%), increased creatine phosphokinase (7%) and hypertension (6%).1
Important safety information and recommendations for the use of BRAFTOVI and MEKTOVI will be detailed in the summary of product characteristics (SmPC), which will be published in the European Public Assessment Report (EPAR) and made available in all official EU languages if marketing authorisation is granted by the EC.
On 27 June 2018, Pierre Fabre’s partner Array BioPharma, which has exclusive rights for these medicines in the United States (US), announced that BRAFTOVI and MEKTOVI were approved by the Food and Drug Administration (FDA) in the US for the treatment of unresectable or metastatic melanoma with a BRAF V600E or BRAF V600K mutation, as detected by an FDA-approved test.3,4 BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma. BRAFTOVI and MEKTOVI are investigational medicines and are not currently approved in any other country outside of the US. Applications for marketing authorisation for BRAFTOVI and MEKTOVI in other countries are currently under review.
About BRAF-mutant Metastatic Melanoma
Melanoma develops when unrepaired DNA damage to skin cells triggers mutations that may lead them to multiply and form malignant tumours. Metastatic melanoma is the most serious and life-threatening type of skin cancer and is associated with low survival rates.5,6 There are a variety of gene mutations that can lead to metastatic melanoma. The most common genetic mutation in metastatic melanoma is BRAF. There are about 200,000 new cases of melanoma diagnosed worldwide each year, approximately half of which have BRAF mutations, a key target in the treatment of metastatic melanoma.6–9
About BRAFTOVI (encorafenib) and MEKTOVI (binimetinib)
BRAFTOVI (encorafenib) is an oral small-molecule BRAF kinase inhibitor and MEKTOVI (binimetinib) is an oral small-molecule MEK inhibitor which targets key enzymes in the MAPK signalling pathway (RAS-RAF-MEK-ERK). Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, including melanoma, colorectal cancer, non-small-cell lung cancer, thyroid and others.
Pierre Fabre has exclusive rights to develop and commercialise BRAFTOVI and MEKTOVI worldwide, except in the US and Canada, where Array BioPharma retains exclusive rights; Israel, where Medison has exclusive rights; and in Japan and South Korea, where Ono Pharmaceutical has exclusive rights to commercialise both products.
The COLUMBUS trial (NCT01909453) is a two-part, international, randomised, open-label, Phase 3 trial evaluating the efficacy and safety of BRAFTOVI (encorafenib) in combination with MEKTOVI (binimetinib) compared with vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAF V600 mutation.1 All secondary efficacy analyses, including OS, are descriptive in nature. More than 200 sites across North America, Europe, South America, Africa, Asia and Australia participated in the COLUMBUS trial.
The CHMP positive opinion is based on results from the Phase 3 COLUMBUS trial, which demonstrated that the combination improved median PFS, compared with vemurafenib alone (14.9 months versus 7.3 months, respectively: HR 0.54, 95% CI, 0.41–0.71; p<0.0001).1 As presented at ASCO in June 2018, treatment with BRAFTOVI and MEKTOVI achieved a median OS of 33.6 months, compared with 16.9 months for patients treated with vemurafenib as a monotherapy (HR 0.61, 95% CI, 0.47–0.79; p<0.0001) in the planned analysis of OS in the COLUMBUS trial.2 Adverse events leading to discontinuation that were suspected to be related to the study treatment occurred in 6% of patients.1 The most common Grade 3–4 adverse events, seen in more than 5% of patients, were: increased gamma-glutamyltransferase (9%), increased creatine phosphokinase (7%) and hypertension (6%).1
About Pierre Fabre
With a portfolio representing a continuum of activities spanning from prescription drugs and consumer healthcare products to dermo-cosmetics, Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies. Its portfolio includes several global brands and franchises, which include Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Galénic, Elancyl, Naturactive, Pierre Fabre Health Care, Pierre Fabre Oral Care, Pierre Fabre Dermatologie and Pierre Fabre Oncologie.
In 2017, Pierre Fabre generated 2,318 million euros in revenues, of which 62% came from its international business and 61% from its dermo-cosmetics division. Pierre Fabre, which has always been headquartered in the South-West of France, counts about 13,500 employees worldwide, owns subsidiaries and offices in 47 countries and enjoys distribution agreements in over 130 countries. In 2017, Pierre Fabre dedicated ca. 175 million euros to R&D efforts, split between oncology, central nervous system, consumer healthcare, dermatology and dermo-cosmetics.
Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a government-recognised public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan.
The independent French certification group AFNOR audited Pierre Fabre for its corporate social responsibility policy at the “exemplary” level, according to the ISO 26000 standard for CSR.
 Dummer R, et al. The Lancet 2018;19 (5): 603–615.
 Dummer R, et al. J Clin Oncol 2018;36 (suppl): abstr 9504.
 BRAFTOVI® Prescribing Information. Array BioPharma Inc., June 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210496lbl.pdf. Accessed July 2018.
 MEKTOVI® Prescribing Information. Array BioPharma Inc., June 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210498lbl.pdf. Accessed July 2018.
 Melanoma Skin Cancer. American Cancer Society. Available at: https://www.cancer.org/cancer/melanoma-skin-cancer.html. Accessed July 2018.
 A Snapshot of Melanoma. National Cancer Institute. Available at: https://seer.cancer.gov/statfacts/html/melan.html. Accessed July 2018.
 Globocan 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. Available at: http://globocan.iarc.fr/Pages/fact_sheets_population.aspx. Accessed July 2018.
 Klein O, et al. Eur J Cancer 2013;49(5):1073-9.
 American Cancer Society. What Causes Melanoma Skin Cancer? 2016. Available at: https://www.cancer.org/cancer/melanoma-skin-cancer/causes-risks-prevention/what-causes.html. Accessed July 2018.
Valérie Roucoules, (33) 1 49 10 83 84
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
IFF Announces Pricing of $1,500,000,000 Senior Notes Offering24.9.2018 22:25 | Pressemelding
Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF), a leading innovator of sensorial experiences that move the world, today announced that it has priced its public offering of $300,000,000 aggregate principal amount of its 3.400% senior notes due 2020, $400,000,000 aggregate principal amount of its 4.450% senior notes due 2028 and $800,000,000 aggregate principal amount of its 5.000% senior notes due 2048. IFF intends to use the net proceeds from the offering to pay a portion of the consideration for the previously announced merger with Frutarom Industries Ltd. and to pay related fees and expenses. IFF anticipates that the offering will close on September 26, 2018, subject to customary closing conditions. The offering is not contingent upon the consummation of the merger. If the closing of the merger has not occurred on or prior to February 7, 2019, or, if prior to such date, the merger agreement with Frutarom is terminated, IFF will be required t
Iberdrola Recognized as United Nations Global Compact LEAD24.9.2018 21:12 | Pressemelding
Today, Iberdrola, one of the world’s largest utilities and the leading renewable energy producer, is pleased to announce that the Company has been recognized as Global Compact LEAD for demonstrating its ongoing commitment to the United Nations Global Compact and its Ten Principles for responsible business. Announced at UN Headquarters in New York during the UN Global Compact Leaders Summit 2018, Iberdrola was identified as being among the highest-engaged participants of the world’s largest corporate sustainability initiative. Lise Kingo, CEO and Executive Director of the UN Global Compact, said, “LEAD companies represent the highest level of engagement with the UN Global Compact. Achieving the Sustainable Development Goals and creating the world we want will not happen without bold action from the responsible business community. We need companies of all sizes — like the ones recognized today — to improve their performance, no matter where they are on their sustainability journey.” “Sin
Pre-Registration for MapleStory 2 Starts Today24.9.2018 17:00 | Pressemelding
Pre-registration for MapleStory 2, the newest MMORPG adventure in Maple World, is available starting today. From September 24 through October 8, players can sign-up on the MapleStory 2 Pre-Registration site available here and earn exclusive rewards! Pre-registration web rewards will include unique in-game items such as the Roosting Seagull, Rustic Mushcabin Name Tag, and the Dusty Rickshaw. From September 24 through October 8, players can also receive a Mint Body Pillow by retweeting the new Runeblade trailer on Twitter and/or liking on Facebook. In addition to pre-registration, players who purchased a Founder’s Pack can jump into Head Start starting October 1, which will allow them to join MapleStory 2 's vibrant and immersive world ahead of global launch on October 10. Along with beta improvements, Head Start (October 1 - October 10) will include: Character progression that carries over to the official launch 6 character slots Founder’s Pack items Access to Gemstones Lv. 1 - 50 Quest
First Engineering Faculty in Canada Named after a Woman: Business Leader Gina Cody Makes Historic $15 Million Donation to Montreal’s Concordia University24.9.2018 15:15 | Pressemelding
Three decades after becoming the first woman to earn a PhD in building engineering from Concordia University, Gina Parvaneh Cody, MEng 81, PhD 89, has made history by giving $15 million to her alma mater. In recognition of her transformative gift to the “Campaign for Concordia: Next-Gen. Now”, the university has named its faculty of engineering and computer science after the alumna. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180924005425/en/ (Photo: Business Wire) The Gina Cody School of Engineering and Computer Science is the first engineering faculty in Canada — and one of the first internationally — to be named after a woman. Gina Cody, a top business leader and building engineer, credits much of her success to Concordia because the university provided her with an entrance scholarship. “I arrived in Canada as a young student from Iran in 1979 with $2,000,” she says. “Concordia welcomed me and provided me with support
Dole’s Standard Fruit Celebrates 20-Year Milestone as Environmental Leader24.9.2018 15:00 | Pressemelding
Earlier in September Dole Food Company participated in a celebration of the twentieth anniversary of the company’s initial receipt of its ISO 14001 Certification. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180924005079/en/ Dole Fresh Fruit President Renato Acuña speaks at the anniversary celebration of Dole's landmark environmental sustainability certification. (Photo: Business Wire) On July 2, 1998, Standard Fruit Company of Costa Rica S.A., a subsidiary of Dole Food Company, Inc., became the first agricultural and banana company in the world to receive the globally recognized ISO 14001 Certification for its environmental management policy and the establishment of its Integrated Management System. With the certification, the company further strengthened its robust Environmental Management System, with results that place it at the forefront in the sustainable production of bananas and pineapples. The celebration event, h
Helsinki Joins New York in Commitment to Review Local Progress Toward Global Sustainable Development Goals24.9.2018 14:42 | Pressemelding
In July 2018, the City of New York became the first city in the world to submit to the United Nations its progress toward the Sustainable Development Goals (SDG’s) on city level. As the first European city Helsinki will follow New York City and become the second city in the world in effort to showcase crucial role of cities in achieving UN agenda for people, prosperity and planet. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180924005633/en/ As the first European city Helsinki will follow New York City and become the second city in the world in effort to showcase crucial role of cities in achieving UN agenda for people, prosperity and planet. Photo: Jussi Hellsten The Mayor of Helsinki Jan Vapaavuori announced Helsinki’s commitment to the voluntary local review at a panel conversation with New York City’s Commissioner of International Affairs Penny Abeywardena at the Social Good Summit in New York City on Sunday. Even thou