CHMP Issues a Positive Opinion on Janssen’s ZYTIGA® to Include Earlier Stage Prostate Cancer Patients
Janssen-Cilag International NV (“Janssen”) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the existing marketing authorisation for ZYTIGA® (abiraterone acetate) plus prednisone / prednisolone to include an earlier stage of prostate cancer than its current indications. If approved by the European Commission, abiraterone acetate plus prednisone / prednisolone in combination with androgen deprivation therapy (ADT) can be used for the treatment of adult men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC).1
“As shown by the results from the LATITUDE study, adding abiraterone acetate plus prednisone / prednisolone to ADT alone significantly improves overall survival and radiographic progression-free survival in men with metastatic hormone-sensitive prostate cancer and high-risk features in comparison to treating patients with ADT alone, where median survival is currently less than three years. Today’s decision means we are one step forward in ensuring mHSPC men across Europe may be able to benefit from this treatment soon,” said Professor Karim Fizazi, principal investigator of the LATITUDE trial and Head of the Medical Oncology Department at Institute Gustave Roussy.
The CHMP recommendation is based on data from the multinational, multicentre, randomised, double-blind, placebo-controlled Phase 3 study, LATITUDE. The trial was designed to determine if newly diagnosed patients with mHNPC who have high-risk prognostic factors benefit from the addition of abiraterone acetate and prednisone to androgen deprivation therapy (ADT) vs placebos and ADT.2 Data were presented at the 2017 American Society of Clinical Oncology congress in Chicago, USA and published in the New England Journal of Medicine.
“We are very pleased with the CHMP’s decision which recommends abiraterone acetate plus prednisone / prednisolone in combination with ADT for use in adult patients with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer. Janssen Oncology has played a significant role in transforming the way prostate cancer is treated so far and aims to continue this progress,” said Dr. Ivo Winiger-Candolfi, Oncology Solid Tumor Therapy Area Lead, Janssen Europe, Middle East and Africa.
Abiraterone acetate plus prednisone / prednisolone has already been approved by the European Commission (EC) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated and of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.3
In the LATITUDE study, the safety profile of ADT in combination with abiraterone acetate plus prednisone was consistent with prior studies in patients with metastatic castration-resistant prostate cancer (mCRPC). Most common adverse events were elevated incidences of mineralocorticoid-related hypertension and hypokalemia in the ADT in combination with abiraterone acetate plus prednisone arm compared with ADT and placebos.4 The observed degrees of hypertension and hypokalemia were both medically manageable with antihypertensive medications and potassium supplements as needed, only rarely required treatment discontinuation, and seldom led to serious consequences.4
The CHMP’s Positive Opinion will now be reviewed by the European Commission, which has the authority to grant approval of the new indication.
NOTES TO EDITORS
About high-risk metastatic hormone-sensitive prostate cancer (mHSPC)
Not all prostate cancer is the same. It ranges from cancer confined to the prostate gland to cancer that has spread outside of the prostate to the lymph nodes, bones, or other parts of the body. The extent or spread of prostate cancer determines its stage.5 Hormone-sensitive prostate cancer (HSPC) refers to a stage of the disease when the patient is still sensitive to treatment with ADT.6 Patients with newly diagnosed mHSPC, particularly with high-risk characteristics, have a poor prognosis. ADT plus docetaxel has shown improved outcomes in mHSPC when compared to ADT alone, but many patients are not candidates for docetaxel and may benefit from alternative therapy.7 Also, while the majority of patients initially start on ADT, it usually becomes less effective over time.8,9,10
About the LATITUDE Trial 2
The Phase 3, multinational, multicentre, randomised, double-blind, placebo-controlled LATITUDE study enrolled 1,199 newly diagnosed patients with metastatic hormone-naïve prostate cancer (mHNPC) and was conducted at 235 sites in 34 countries in Europe, Asia-Pacific, Latin America, and Canada. A total number of 597 patients were randomised to receive ADT in combination with abiraterone acetate plus prednisone (n=597), while 602 patients were randomised to receive ADT and placebos (n=602). Patients included had high-risk mHNPC documented by positive bone scan or metastatic lesions at the time of diagnosis on computed tomography (CT) or magnetic resonance imaging (MRI). Additionally, patients had to have at least two of the three following high-risk factors associated with poor prognosis:2
- Gleason score ≥8
- ≥3 bone lesions
- presence of measurable visceral metastases
These results served the basis for Janssen’s Type II variation application submission to the European Medicines Agency (EMA), seeking to expand the existing marketing authorisation for abiraterone acetate plus prednisone or prednisolone to include the treatment of adult men with newly-diagnosed, high-risk metastatic hormone-sensitive prostate cancer (mHSPC). If approved, this will broaden the use of abiraterone acetate plus prednisone / prednisolone to include an earlier stage of prostate cancer than its current indications.
Overall, the safety profile of ADT in combination with abiraterone acetate plus prednisone was consistent with prior studies in patients with metastatic castration-resistant prostate cancer (mCRPC). Most common adverse events were elevated incidences of mineralocorticoid-related hypertension and hypokalemia in the ADT in combination with abiraterone acetate plus prednisone arm compared with ADT and placebos. The incidence rate of grade 3 or higher hypertension (20% vs. 10%) was greater than that observed in prior studies of abiraterone acetate in mCRPC patients. There were no serious sequelae from the increased rate of hypertension. The incidence of hypokalemia was higher than that reported in prior Phase 3 studies of abiraterone acetate plus prednisone in mCRPC; however, only two patients discontinued treatment due to hypokalemia and there were no hypokalemia-related deaths. Mineralocorticoid-associated adverse events were generally medically manageable.
About abiraterone acetate
Abiraterone acetate plus prednisone / prednisolone is the only approved therapy in mCRPC that inhibits production of androgens (which fuel prostate cancer growth) at all three sources that are important in prostate cancer - the testes, adrenals and the tumour itself.3,11,12
In 2011, abiraterone acetate in combination with prednisone / prednisolone was approved by the European Commission (EC) for the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
In December 2012, the EC granted an extension of the indication for abiraterone acetate permitting its use, in combination with prednisone or prednisolone, for the treatment of mCRPC, in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.3
Further Information 3
The most common adverse reactions seen with abiraterone acetate plus prednisone / prednisolone include urinary tract infection, hypokalemia, hypertension, and peripheral oedema.
For a full list of side effects and for further information on dosage and administration, contraindications and other precautions when using abiraterone acetate plus prednisone / prednisolone please refer to the summary of product characteristics, which is available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002321/WC500112858.pdf
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/emea. Follow us on http://www.twitter.com/janssenEMEA for our latest news.
Cilag GmbH International; Janssen Biotech, Inc.; Janssen Oncology, Inc. and Janssen-Cilag International NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the continued development and potential of abiraterone acetate plus prednisone / prednisolone. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns or financial distress of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1 European Medicines Agency. ZYTIGA CHMP meeting highlights. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/002321/WC500236610.pdf. Last accessed October 2017.
2 National Institutes of Health. A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC). Available at: https://clinicaltrials.gov/show/NCT01715285 . Last accessed October 2017.
3 ZYTIGA® summary of product characteristics (February 2017). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002321/WC500112858.pdf. Last accessed October 2017.
4 Fizazi, K. et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. New England Journal of Medicine 2017; 377:352-360.
5 Prostate Cancer Foundation. Staging the disease. Available at: https://www.pcf.org/c/staging-the-disease/ Last accessed October 2017.
6 Moul, J.W. Hormone naïve prostate cancer: predicting and maximizing response intervals. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4814946/. Last accessed October 2017.
7 Engel Ayer Botrel, T. Efficacy and Safety of Combined Androgen Deprivation Therapy (ADT) and Docetaxel Compared with ADT Alone for Metastatic Hormone-Naive Prostate Cancer: A Systematic Review and Meta-Analysis. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4911003/. Last accessed October 2017.
8 Gillessen S, et al. Management of patients with advanced prostate cancer: recommendations of the St Gallen Advanced Prostate Cancer Consensus Conference. Ann Oncol. 2015;26:1589-1604.
9 Cornford P, et al. Guidelines on Prostate Cancer. Part II: treatment of relapsing, metastatic, and castration-resistant prostate cancer. Eur Urol. 2017;71:630-642.
10 American Cancer Society. “Treating Prostate Cancer That Doesn’t Go Away or Comes Back After Treatment.” Available at: https://www.cancer.org/cancer/prostate-cancer/treating/recurrence.html. Last accessed October 2017.
11 Hoy, SM. et al. Abiraterone Acetate: A review of its use in patients with metastatic castration-resistant prostate cancer drugs. Drugs 2013; 73:2077-2091.
12 Ritch, CR. Cookson, MS. Advances in the management of castration resistant prostate cancer. BMJ. 2016 Oct 17;355:i4405. Doi: 10.1136/bmj.i4405.
Phone: +353 85-744-6696
Phone: +1 732-524-3922
Joseph J. Wolk
Phone: +1 732-524-1142
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Tan Delta: New Oil Condition Monitoring Kit for Gas Engine Operators Reduces Daily Operating Costs, Improves Equipment Efficiency and Extends Equipment Life.23.11.2017 16:38 | Tiedote
The new Gas Engine oil condition monitoring kit from Tan Delta Systems can be quickly and easily fitted to any gas engine and enables the oil to be monitored and tracked continuously in real time enabling significantly reduced maintenance costs, increased equipment efficiency and extended equipment life. Operators can expect their investment returned in under four months followed by many years of net financial and operational benefits. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171123005177/en/ Gas Engine Oil Condition Monitoring (Photo: Business Wire) The kit includes everything needed for quick and easy installation on any gas engine operating in any environment. No more need for expensive laboratory oil testing. Reduce daily operating costs by optimising maintenance schedules. Protect a
Making Institut Curie a Reference for Technology Transfer in Oncology23.11.2017 16:00 | Tiedote
Institut Curie has adopted an ambitious strategy for technology transfer and partnerships with innovative companies. This new dynamic, initiated within the framework of the 2015-2020 MC21 strategic plan (Marie Curie in the 21 st century), aims at positioning the Institut Curie as a reference for technology transfer in oncology. The strategy ambition to better accompany Institut Curie researchers and physicians in the protection, development and commercialization of their inventions, and reinforces support for the setting-up of collaborations with innovative companies. "The objective is to optimize the identification, promotion and transfer of all the scientific, technological and medical resources of the Institute in an open innovative approach" says Amaury Martin, Executive Director of Institut Curie Technology Transfer
Wealth Dynamix (WDX) Ranks No.18 in the 2017 Tech Track 100 by the Sunday Times and 19th Fastest Growing Technology Company in the UK in the 2017 Deloitte Technology Fast 5023.11.2017 11:00 | Tiedote
WDX ranks No.18 in the 17th annual Sunday Times Hiscox Tech Track 100 league table league which consisted of the top 100 private technology, media and telecoms (TMT) companies in Britain. WDX recorded a 155% average annual sales growth per year over the last 3 years with sales reaching £6.4M in September 2016 and £9m by end of September 2017. More recently, in November 2017, WDX also announces ranking No.19 in the 2017 Deloitte UK Technology Fast 50, a ranking of the 50 fastest growing technology companies in the UK. Rankings are based on percentage revenue growth over the last four years of which, WDX grew 1,563% during this period. WDX attributed this revenue growth to the team’s hard work and the positive change in attitude toward technology in the Wealth and Investment Management industry. WDX’s CEO, Gary Linieres credits the team with the company’s revenue growth. He sa
Mobidiag Signs Agreement with Interlux for the Distribution of Amplidiag® Diagnostic Tests and Instruments in Estonia23.11.2017 10:00 | Tiedote
Mobidiag Ltd, a Finnish molecular diagnostics company, today announced a distribution agreement with Interlux OÜ, supplier of technologies for medicine, science and biotechnology industry. Under this agreement, Interlux becomes the exclusive distributor of the Amplidiag® product line in Estonia, in vitro diagnostic tests and compatible instrument for the detection of gastrointestinal infections. “Thanks to a large distribution network, our Amplidiag product line is now accessible in most Western European countries. This new distribution agreement allows us to introduce the Amplidiag product line to the Baltic region starting with Estonia. We are then very happy to start this new partnership with Interlux to support us in this new market”, said Miquel Vernet, CCO at Mobidiag. “Cooperation with Mobidiag offers the customers of Interlux high-quality diagnostic results. I believ
OCP Announces Date of 2017 Third Quarter and Nine Month Results22.11.2017 19:59 | Tiedote
OCP S.A., a global leader in the fertilizer industry, will release its third quarter and nine month 2017 results on Thursday, November 30, 2017. The results will be available to holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers on the OCP Intralinks portal at 9 a.m. EDT and 2 p.m. Morocco/London time. OCP senior management will host a conference call to discuss 2017 third quarter/nine month results at 10 a.m. EDT and 3 p.m. Morocco/London time on Thursday, November 30, 2017 for holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers. Eligible parties that have not already registered for access to the Intralinks portal may do so by contacting the Investor Relations Department by emailing firstname.lastname@example.org. About OCP OCP is a global leader in the fert
Tata Motors Charts Out 'Connecting Aspirations' As Its New Corporate Brand Identity in Global Markets22.11.2017 17:46 | Tiedote
As part of the company’s transformation journey undertaken in 2016, Tata Motors commenced a comprehensive project to articulate its corporate branding. Basis a thorough analysis of the existing and the desired future state of the Company, Tata Motors has defined its new brand identity as ‘Connecting Aspirations’ across 46 markets, internationally. ‘Connecting Aspirations’, as the new defining maxim, represents the personality of the brand as an interconnected system of mobility solutions, that are intelligent, perceptive, warm and expressive. It’s a symbolic tagline that represents the company’s past, present and future. It is humble yet bold, a statement as well as a challenge. It will define the way Tata Motors communicates with its internal as well as external stakeholders, and work as an all-encompassing guiding principle across business units.” Speaking on the
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme