Business Wire

Pierre Fabre receives positive CHMP opinion for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) in adult patients with advanced BRAF-mutant melanoma

Del

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.

About COLUMBUS

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.

www.pierre-fabre.com
@PierreFabre

References

[1] Dummer R, et al. The Lancet 2018;19 (5): 603–615.

[2] Dummer R, et al. J Clin Oncol 2018;36 (suppl): abstr 9504.

[3] BRAFTOVI® Prescribing Information. Array BioPharma Inc., June 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210496lbl.pdf. Accessed July 2018.

[4] MEKTOVI® Prescribing Information. Array BioPharma Inc., June 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210498lbl.pdf. Accessed July 2018.

[5] Melanoma Skin Cancer. American Cancer Society. Available at: https://www.cancer.org/cancer/melanoma-skin-cancer.html. Accessed July 2018.

[6] A Snapshot of Melanoma. National Cancer Institute. Available at: https://seer.cancer.gov/statfacts/html/melan.html. Accessed July 2018.

[7] 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.

[8] Klein O, et al. Eur J Cancer 2013;49(5):1073-9.

[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.

Contact information

Pierre Fabre
Valérie Roucoules, (33) 1 49 10 83 84
valerie.roucoules@pierre-fabre.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(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

China National Medical Products Administration (NMPA) Approves Gilead’s Vemlidy® (Tenofovir Alafenamide) for Chronic Hepatitis B Virus (HBV) Infection19.11.2018 03:00Pressemelding

Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Medical Products Administration (NMPA) has approved Vemlidy® (tenofovir alafenamide, TAF) 25 mg, a once-daily treatment for chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35 kg). Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to Gilead’s Viread® (tenofovir disoproxil fumarate, TDF) 300 mg but at one-tenth of the dose. Data show that because Vemlidy has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to Viread, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. In clinical trials, Vemlidy demonstrated improved renal and bone laboratory safety parameters compared to Viread. “With the approval of Vemlidy, physicians can now offer their patients a treatment that retains the efficacy of TDF while improving renal and bone safety parameters in cli

Celltrion Healthcare: Biosimilars Have the Potential to Deliver Dramatic Cost Savings for US and European Healthcare Systems19.11.2018 00:01Pressemelding

Celltrion Healthcare outlined their vision of ‘shaping future healthcare by improving access to biosimilars’ at the 5th Annual Biosimilars USA Conference in New Jersey, US. Biosimilars offer healthcare providers and patients greater treatment choice and value, better access to treatments and improved patient outcomes. According to data provided by IMS Health, biosimilars could lead to cumulative savings of up to 107 billion USD by 2020 in the United States (US) and the top five European Union (EU) countries.1 The EU has made significant progress in unlocking the potential of biosimilars through continuous education of providers, payers and patients. This has been critical to EU biosimilar acceptance but has not been seen in the US, which has lagged behind. During a presentation on the opportunities and challenges presented by the use of biosimilars in the US, Celltrion Healthcare highlighted several challenges affecting the uptake of biosimilars within the US market. Both physicians an

Abu Dhabi to Host Interfaith Alliance For Safer Communities: Child Dignity in the Digital World Forum on 19 November17.11.2018 13:40Pressemelding

Held under the patronage of His Highness Sheikh Mohammed bin Zayed Al Nahyan, Crown Prince of Abu Dhabi and Deputy Supreme Commander of the UAE Armed Forces, the UAE will host the first edition of the Interfaith Alliance For Safer Communities Forum on November 19-20 in recognition of the country’s leading role in promoting tolerance and interfaith dialogue. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181117005008/en/ His Highness Sheikh Mohammed bin Zayed Al Nahyan, Crown Prince of Abu Dhabi and Deputy Supreme Commander of the UAE Armed Forces (Photo: AETOSWire) The forum will host 450 guests including religious leaders, NGOs and heads of industry to discuss ongoing social challenges and develop comprehensive solutions for protecting youth from cybercrime. The Interfaith Alliance For Safer Communities Forum is an expansion of the Child Dignity in the Digital World Congress which was held in October 2017 in the Vatican, an

Philip Morris International and Dorna Switch Gears in Quest for a World without Tobacco Smoke17.11.2018 11:00Pressemelding

Philip Morris International Inc. (PMI) (NYSE:PM) and Dorna Sports S.L., the commercial rights holder for the world FIM MotoGP Championships, have extended their partnership until the end of 2021. The two organizations have collaborated successfully for 26 years. As of 2019, the partnership will focus on advancing the cause of a smoke-free world. More than 1 billion people smoke today and, according to the World Health Organization, will continue to smoke in the near future. PMI has committed to transform its business and encourage all men and women who would otherwise continue smoking to replace cigarettes with better alternatives as soon as possible. With around 350 million MotoGP fans worldwide, MotoGP can play a significant role in positively impacting the lives of people who smoke and those around them. “The best choice for consumers concerned about the health risks of smoking is to quit tobacco and nicotine altogether. Today, however, technology, science and innovation provide a r

Schlumberger Announces Fourth-Quarter and Full-Year 2018 Results Conference Call16.11.2018 18:00Pressemelding

Schlumberger Limited (NYSE:SLB) will hold a conference call on January 18, 2019 to discuss the results for the fourth quarter and full year ending December 31, 2018. The conference call is scheduled to begin at 8:30 am US Eastern time and a press release regarding the results will be issued at 7:00 am US Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (800) 288-8967 within North America or +1 (612) 333-4911 outside of North America approximately 10 minutes prior to the start of the call, and ask for the “Schlumberger Earnings Conference Call.” A webcast of the conference call will be broadcast simultaneously at www.slb.com/irwebcast on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call, a replay will be available at www.slb.com/irwebcast until February 18, 2019, and can be accessed by dialing +1 (800)

Visa Strengthens Commitment to Growing Digital Payments in India16.11.2018 14:33Pressemelding

Visa (NYSE: V) today announced a minority investment in BillDesk, a leading platform for online payments and bill payments in India. Visa’s investment and collaboration will help BillDesk develop new product lines for its payments and loyalty businesses and also expand its footprint into other geographies. The investment will be subject to necessary statutory approvals and is expected to have no direct bearing on Visa’s existing Indian business. “As a leading payments player in India, BillDesk has been a long time business partner to Visa. Having worked with BillDesk’s founders over the years, the Visa leadership has been consistently impressed with their vision, market knowledge and execution capabilities, as well as alignment on values. This investment further reinforces our long-term commitment to India’s digital payments growth story,” said Asia Pacific regional president, Chris Clark. “We are truly excited by this investment from the world's largest global payment network, Visa. W