Janssen receives positive CHMP opinion for ERLEADA™ (apalutamide) for patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for apalutamide, a next generation oral androgen receptor inhibitor for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.2 The CHMP’s positive opinion will now be reviewed by the European Commission (EC), which has the authority to grant approval for the use of apalutamide.
The CHMP’s positive opinion is based on data from the pivotal SPARTAN Phase 3 clinical study which assessed the safety and efficacy of apalutamide versus placebo in patients with nmCRPC who have a rapidly rising prostate specific antigen (PSA) level despite receiving continuous androgen deprivation therapy (ADT). The SPARTAN clinical study showed that apalutamide, when added to ADT, significantly reduced the risk of developing distant metastasis or death (metastasis free survival [MFS]) by 72 percent, compared to placebo in combination with ADT (HR = 0.28; 95% CI, 0.23-0.35; P < 0.001). The median MFS was improved by over two years (40.5 months vs 16.2 months) in patients with nmCRPC whose PSA is rapidly rising.1 This study was published in The New England Journal of Medicine.
The most common Grade 3/4 treatment-emergent adverse events in the SPARTAN study were hypertension (14.3 percent vs. 11.8 percent), rash (5.2 percent vs. 0.3 percent), fall (1.7 percent vs. 0.8 percent) and fracture (2.7 percent vs. 0.8 percent). Treatment discontinuation due to adverse events was 11 percent in the apalutamide arm compared to 7 percent in the placebo arm. Rates of serious adverse events were similar in the apalutamide in combination with ADT arm versus placebo in combination with ADT arm (25 percent vs. 23 percent respectively).1
“Data from the SPARTAN study showed that apalutamide significantly improves metastasis free survival for patients with castration-resistant prostate cancer,” said Dr Simon Chowdhury, Consultant Medical Oncologist, Guy's and St Thomas' Hospitals. “Nearly 90 percent of patients with castration-resistant prostate cancer will eventually develop bone metastases. At that point their prognosis worsens dramatically. Delaying the spread of cancer is therefore critical for patients living with prostate cancer.” *
“We are pleased with the CHMP’s decision to recommend approval of apalutamide for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer,” said Dr. Ivo Winiger-Candolfi M.D., Janssen Oncology Solid Tumor Therapy Area Lead, Europe, Middle East and Africa, Cilag GmbH International. “We know that each prostate cancer patient journey is unique and today’s positive CHMP opinion brings us one step closer to offering patients an effective treatment option that delays the spread of their disease.”
ENDS
About Non-Metastatic Castration-Resistant Prostate Cancer
Non-metastatic castration-resistant prostate cancer (CRPC) refers to a disease stage when the cancer no longer responds to medical or surgical treatments that lower testosterone, but has not yet been discovered in other parts of the body using a bone scan or CT scan.3 Features include: lack of detectable metastatic disease; rapidly rising prostate-specific antigen while on androgen deprivation therapy (ADT) and serum testosterone level below 50 ng/dL.3 Ninety percent of patients with non-metastatic CRPC will eventually develop bone metastases, which can lead to pain, fractures and spinal cord compression.4 The relative 5-year survival rate for patients with distant stage castration sensitive or castration resistant prostate cancer is 30 percent.5,6
About apalutamide
Apalutamide is an investigational, next-generation oral androgen receptor (AR) inhibitor that blocks the androgen signaling pathway in prostate cancer cells. Apalutamide inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the AR; by stopping the AR from entering the cancer cells; and by preventing the AR from binding to the DNA of the cancer cell.7
Janssen submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) in February 2018 seeking approval for apalutamide for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). Apalutamide received approval from the United States Food and Drug Administration for the treatment of patients with nmCRPC in February 2018, shortly followed by approvals in Canada, Australia, Argentina and Brazil.8,9,10,11
About the Janssen Pharmaceutical Companies of Johnson & Johnson
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 at http://www.twitter.com/janssenEMEA. Janssen-Cilag International N.V. and Cilag GmbH International are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
* Dr Chowdhury is lead investigator on the SPARTAN study. He was not compensated for any media work.
# # #
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of ERLEADA™ (apalutamide). 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 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 December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements,” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, 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.
# # #
References
1 Smith, R. M. et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med 2018; 378:1408-1418. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa1715546?query=featured_home. Last accessed October 2018.
2 European Medicines Agency. Apalutamide CHMP meeting highlights. Available at: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-november-2018 . Last accessed November 2018.
3 Hong JH, Kim IY. Non-metastatic Castration-Resistant Prostate Cancer. Korean J Urol. 2014 Mar;55(3):153-60. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3956942/. Last accessed October 2018.
4 Hotte SJ, Saad F. Current management of castrate-resistant prostate cancer. Curr Oncol. 2010; 17(Suppl 2): S72–S79. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2935714/. Last accessed October 2018.
5 Saad F, et al. The 2015 CUA-CUOG Guidelines for the management of castration-resistant prostate cancer (CRPC). Can Urol Assoc J. 2015;9(3-4):90-96.
6 American Cancer Society. Survival Rates for Prostate Cancer. Available at: www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/survival-rates.html. Last accessed October 2018.
7 Clegg NJ, et al. ARN-509: a novel antiandrogen for prostate cancer treatment. Cancer Res. 2012;72:1494-1503.
8 FDA. FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint. Available at https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm596768.htm. Last accessed October 2018.
9 Pan-Canadian Oncology Drug Review. Available at: https://cadth.ca/sites/default/files/pcodr/pcodr_apalutamide_erleada_crpc_in_cgr%20.pdf. Last accessed October 2018.
10 ERLYAND®. Australian Product Information. Available at: https://www.janssen.com/australia/sites/www_janssen_com_australia/files/prod_files/live/erlyand_pi.pdf Last accessed October 2018.
11 ERLEADA® Identificação Do Medicamento. Available at: https://www.janssen.com/brasil/sites/www_janssen_com_brazil/files/prod_files/live/erleada_pub_vp.pdf . Last accessed October 2018.
Job code: PHEM/APL/1018/0007
Date of preparation: October 2018
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181116005228/en/
Contact information
Media Enquiries:
Natalie Buhl
Phone: +353 85-744-6696
Investor
Relations
Christopher DelOrefice
Office: +1 732-524-2955
Lesley
Fishman
Office: +1 732-524-3922
About 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.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Mainstay Medical Announces Publication of the First Neuromodulation Study for Low Back Pain with 5-Year Follow-Up19.3.2024 13:00:00 CET | Press release
Mainstay Medical Holdings plc today announced the publication of the 5-year follow up from the ReActiv8-B randomized, sham-controlled, double-blinded trial. There were 126 patients who completed the 5-year follow up, and the published data clearly indicated that ReActiv8® Restorative Neurostimulation is a long-term, effective, durable, and safe therapy. ReActiv8 is the only restorative therapy for patients suffering from non-surgical, mechanical CLBP evidenced by multifidus dysfunction. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240319164677/en/ The long-term responses across pain, disability, and health-related quality of life measures are shown in the following graphs. (Graphic: Business Wire) The publication is available here: https://www.sciencedirect.com/science/article/pii/S1094715924000552 The ReActiv8-B study saw multiple patients have their implants removed for resolution of back pain. These removals for success
SWISSto12 Continues Expansion, Growing Team by 25% and Adding New Production Space19.3.2024 13:00:00 CET | Press release
SWISSto12, one of Europe’s fastest growing aerospace companies and a leading satellite and Radio Frequency product manufacturer, announces its continued global expansion. The company has secured additional production space at its headquarters in Switzerland, increasing the size of its existing site to 5,700m2. In addition, SWISSto12 has welcomed several new Satcom engineering experts to its growing team, which has increased by 25% since the start of 2024 to over 125 employees working across its facilities in Switzerland, Europe and the USA. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240318493042/en/ HummingSat I-8 Inmarsat (Photo: Business Wire) SWISSto12 was recently named as one of the world’s “10 Hottest Satellite Companies.” This industry recognition follows the company’s announcement in Q4 2023 of securing over €200 million in customer orders for Radio Frequency subsystems and HummingSat satellites, including from l
AngloGold Ashanti Releases Preliminary Unaudited Condensed Consolidated Financial Statements as of and for the Six Months and the Year Ended 31 December 202319.3.2024 12:04:00 CET | Press release
AngloGold Ashanti plc (“AngloGold Ashanti”, “AGA” or the “Company”) is pleased to provide its preliminary unaudited condensed consolidated financial statements as of and for the six months and the year ended 31 December 2023 (the “FY 2023 Earnings Release”). FY 2023 Financial and Operating Update The FY 2023 Earnings Release should be read together with AngloGold Ashanti’s preliminary financial update for the six months and the year ended 31 December 2023, which was published by the Company on 23 February 2024 (the “FY 2023 Preliminary Financial Update”). No changes have been made in the FY 2023 Earnings Release with respect to the production, cost or cash flow information included in the FY 2023 Preliminary Financial Update. The FY 2023 Preliminary Financial Update combined with the FY 2023 Earnings Release provide the Company’s financial and operating update for the six months and the year ended 31 December 2023. Announcement of Annual General Meeting Date The 2024 Annual General Mee
IFF Announces Sale of its Pharma Solutions Business to Roquette19.3.2024 11:45:00 CET | Press release
IFF (NYSE: IFF) today announced that it has entered into a definitive agreement to sell its Pharma Solutions business unit to French leader of plant-based ingredients Roquette for an enterprise value of up to $2.85 billion, which represents an enterprise value to EBITDA multiple of approximately 13x. IFF’s Pharma Solutions business is a well-established developer and manufacturer of pharmaceutical excipients and includes its Global Specialty Solutions business supporting industrial and methyl cellulosic food applications. The Pharma Solutions business being sold to Roquette is primarily made up of businesses within IFF’s existing Pharma Solutions division, with some adjustments to the perimeter of the transaction designed to align customers, businesses and the manufacturing footprint. “We are pleased to reach an agreement with Roquette that will support Pharma Solutions’ next chapter of growth as a trusted partner for the pharmaceutical industry,” said IFF CEO Erik Fyrwald. "An importa
“Unfortunately, not a lot has changed for girls in football.”19.3.2024 10:00:00 CET | Press release
PUMA CEO Arne Freundt and Alexandra Popp, the captain of the Germany national football team, spoke about leadership and the challenges of women in football. The video interview is part of the sports company’s digital annual report, which was published on March 18 on about.puma.com. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240319731548/en/ Voted Germany’s footballer of the year three times, Alexandra is one of the most prominent ambassadors for women’s football and she is known for her skill and charismatic leadership on the pitch. She started off her career playing in a mixed team, and she distinctly recalled how girls were often belittled and treated unfairly on the pitch. “Football is still pretty tough for girls. The boys in my team were cool. But our opponents were another story. They laughed at you. They said: look, they have a girl in their team, we’ll beat them easily,” Alexandra said. “Or when you play and you