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The Janssen Pharmaceutical Companies of Johnson & Johnson today appear that the Board for Medicinal Articles for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion advising approval for accretion the use of Erleada® (apalutamide) to accommodate the analysis of developed men with metastatic hormone-sensitive prostate blight (mHSPC) in aggregate with androgen denial analysis (ADT).2 The CHMP’s Positive Opinion will now be advised by the European Commission (EC), which has the ascendancy to admission approval for the new use of apalutamide.



The Positive Opinion is based on abstracts from the Appearance 3 TITAN study, which adjourned the accession of apalutamide to ADT – the accepted accepted of affliction in mHSPC – in a ample ambit of patients with mHSPC, behindhand of ache volume, above-mentioned analysis with docetaxel or staging at antecedent diagnosis. The bifold primary endpoints of the abstraction were all-embracing adaptation (OS) and radiographic progression-free adaptation (rPFS). Apalutamide added ADT decidedly bigger OS compared to placebo added ADT with a 33 percent abridgement in the accident of afterlife (HR=0.67; 95% CI, 0.51-0.89; p=0.0053).1 In both abstraction arms, average OS was not reached.1 Apalutamide added ADT additionally decidedly bigger rPFS compared to placebo added ADT with a 52 percent abridgement in accident of radiographic progression or afterlife compared to placebo added ADT (HR=0.48; 95% CI, 0.39-0.60; p<0.0001).1 The average rPFS was 22.1 months for placebo added ADT and not accomplished for apalutamide added ADT.1 The two-year OS rates, afterwards a average chase up of 22.7 months, were 82 percent for apalutamide added ADT compared to 74 percent for placebo added ADT.1 These after-effects were presented at the 2019 American Society of Analytic Oncology (ASCO) Annual Meeting and accompanying appear online in The New England Journal of Medicine.1,3



The assurance profiles for apalutamide added ADT, against placebo added ADT, were agnate with 42 percent against 41 percent of Grade 3/4 adverse contest (AEs) empiric respectively.1 The best accepted Grade ≥3 AEs for apalutamide added ADT against placebo added ADT were hypertension (8.4 percent vs. 9.1 percent) and bark adventurous (6.3 percent vs. 0.6 percent). Analysis cessation due to AEs was 8 percent in the apalutamide arm compared to 5 percent in the placebo arm.1

“Today’s Positive Opinion for apalutamide brings us one footfall afterpiece to accouterment a much-needed analysis advantage for a ample citizenry of patients diagnosed with mHSPC,” said Joaquín Casariego, M.D., Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. “At this date of disease, it is analytical to arbitrate with accession analysis that can prolong adaptation and adjournment progression to the baleful stage, after compromising the affection of activity of patients. We attending advanced to the EC approval of apalutamide in this ambience so we can accompany this avant-garde anesthetic to patients as anon as possible.”

“We are admiring with the CHMP’s Opinion to acclaim approval of apalutamide as a analysis for patients with mHSPC,” said Craig Tendler, M.D., Vice President, Analytic Development and All-around Medical Affairs, Oncology at Janssen Analysis & Development, LLC. “Results from the TITAN abstraction accustomed that the accession of apalutamide to ADT bigger outcomes for a ample ambit of patients with mHSPC, compared to ADT alone, highlighting the acceptation of today’s Opinion. At Janssen, we abide to focus on acclamation acute areas of unmet charge in prostate blight aural our analytic balloon programme and are committed to added exploring how to advance outcomes for patients beyond the absolute ache continuum.”

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In Europe, apalutamide is accustomed for use in adults with non-metastatic castration-resistant prostate blight (nmCRPC) who are at aerial accident of developing metastatic disease.4 In the United States apalutamide is adumbrated for the analysis of nmCRPC and metastatic castration-sensitive prostate blight (mCSPC).5

#ENDS#

About the TITAN Study1,3TITAN is a Appearance 3 randomised, placebo-controlled, double-blind abstraction in men with mHSPC behindhand of admeasurement of ache or above-mentioned docetaxel analysis history. The abstraction included 1,052 patients in intention-to-treat (ITT) citizenry in 23 countries beyond 260 sites in North America, Latin America, South America, Europe and Asia Pacific. Patients with mHSPC were randomised 1:1 and accustomed either apalutamide (240 mg) added connected androgen denial analysis (ADT) (n=525), or placebo added ADT (n=527). The application aeon for the abstraction spanned from December 2015 to July 2017. The abstraction included mHSPC patients with both low- and high-volume disease, those who were anew diagnosed, or those who had accustomed above-mentioned absolute bounded analysis or above-mentioned analysis with up to six cycles of docetaxel or up to six months of ADT for mHSPC. Participants were advised until ache progression or the accident of unacceptable treatment-related toxicity. An absolute data-monitoring board was commissioned by the sponsor to adviser assurance and ability afore unblinding and accomplish abstraction conduct recommendations. Bifold primary endpoints of the abstraction were OS and rPFS. Secondary endpoints included time to cytotoxic chemotherapy, time to affliction progression, time to abiding opioid use and time to skeletal-related event. Exploratory endpoints included time to PSA progression, time to added progression-free adaptation and time to appropriate progression. For added abstraction information, appointment ClinicalTrials.gov.

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About apalutamideApalutamide is an androgen receptor (AR) inhibitor adumbrated for use in Europe for the analysis of patients with non-metastatic castration-resistant prostate blight (nmCRPC) who are at aerial accident of developing metastatic disease.4 In the U.S. apalutamide is adumbrated for the analysis of nmCRPC and metastatic hormone-sensitive prostate blight (mHSPC).5

About Metastatic Hormone-Sensitive Prostate CancerMetastatic hormone-sensitive prostate blight (mHSPC), additionally referred to as metastatic castration acute prostate blight (mCSPC), refers to prostate blight that still responds to androgen denial analysis (ADT) and has advance to added genitalia of the body.6 Patients with mHSPC tend to accept a poor prognosis, with a average all-embracing adaptation (OS) of beneath than bristles years, accent the charge for new analysis options.7,8,9

About the Janssen Pharmaceutical Companies of Johnson & JohnsonAt Janssen, we’re creating a approaching area ache is a affair of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, alive endlessly to accomplish that approaching a absoluteness for patients everywhere by angry affection with science, convalescent admission with ingenuity, and healing abasement with heart. We focus on areas of anesthetic area we can accomplish the better difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn added at www.janssen.com/emea. Chase us at www.twitter.com/janssenEMEA for our latest news. Janssen Analysis & Development, LLC and Janssen-Cilag S.A. are allotment of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking StatementsThis columnist absolution contains “forward-looking statements” as authentic in the Private Securities Litigation Reform Act of 1995 apropos abeyant allowances and added allowances of Erleada (apalutamide). The clairvoyant is cautioned not to await on these advanced statements. These statements are based on accepted expectations of approaching events. If basal assumptions prove inaccurate or accepted or alien risks or uncertainties materialize, absolute after-effects could alter materially from the expectations and projections of Janssen-Cilag S.A., any of the added Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not bound to: challenges and uncertainties inherent in artefact analysis and development, including the ambiguity of analytic success and of accepting authoritative approvals; ambiguity of bartering success; accomplishment difficulties and delays; competition, including abstruse advances, new articles and patents accomplished by competitors; challenges to patents; artefact ability or assurance apropos consistent in artefact recalls or authoritative action; changes in behavior and spending patterns of purchasers of bloom affliction articles and services; changes to applicative laws and regulations, including all-around bloom affliction reforms; and trends against bloom affliction amount containment. A added account and descriptions of these risks, uncertainties and added factors can be begin in Johnson & Johnson’s Annual Report on Form 10-K for the budgetary year concluded December 30, 2018, including in the sections captioned “Cautionary Note Apropos Forward-Looking Statements” and “Item 1A. Accident Factors,” and in the company’s best afresh filed Quarterly Report on Form 10-Q, and the company’s consecutive filings with the Securities and Exchange Commission. Copies of these filings are accessible online at www.sec.gov, www.jnj.com or on appeal from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to amend any advanced account as a aftereffect of new advice or approaching contest or developments.

References1 Chi, K.N. et al. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med 2019; 381:13-24.2 European Medicines Agency. Meeting highlights from the Board for Medicinal Articles for Human Use (CHMP) 9-12 December 2019. Accessible at: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-9-12-december-2019. Last accessed December 2019.3 Chi, K.N. First after-effects from TITAN: A appearance III double-blind, randomized abstraction of apalutamide against placebo in patients with metastatic castration-sensitive prostate blight accepting androgen denial therapy. American Society of Analytic Oncology Annual Meeting 2019. Abstract #5006.4 European Medicines Agency. Erleada Summary of Artefact Characteristics. Accessible at: https://www.ema.europa.eu/en/documents/product-information/erleada-epar-product-information_en.pdf. Last accessed December 2019.5 Erleada artefact advice Accessible at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210951s001lbl.pdf. Last accessed December 2019.6 Cancer.net. Prostate Cancer: Analysis Options. Accessible at: http://www.cancer.net/cancer-types/prostate-cancer/treatment-options. Last accessed December 2019.7 American Blight Society. Adaptation ante for prostate cancer. Accessible at: https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/survival-rates.html. Last accessed December 2019.8 European Association of Urology. Updated guidelines for metastatic hormone-sensitive prostate cancer: abiraterone acetate accumulated with castration is accession standard. Accessible at: https://uroweb.org/wp-content/uploads/Mottet-N.-et-al.-Eur-Urol-733316-321.-Updated-Guidelines-for-Metastatic-Hormone-sensitive-PCa-Abiraterone-Acetate.pdf. Last accessed December 2019.9 Fizazi K. et al. Abiraterone added Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med 2017; 377:352-360.

View antecedent adaptation on businesswire.com: https://www.businesswire.com/news/home/20191213005156/en/

Contacts

Media Enquiries: Laura CoughlanPhone: 353 87 147 9356

Investor Relations: Christopher DelOreficePhone: 1 732 524 2955

Lesley FishmanPhone: 1 732 524 3922

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