Erleada® (Apalutamide) Granted New Indication in China for Treatment of Metastatic Hormone-Sensitive Prostate Cancer

BEIJING, Aug. 14, 2020 /PRNewswire/ -- Xian Janssen Pharmaceutical Ltd., the pharmaceutical subsidiary of Johnson & Johnson in China, announced today that its next-generation androgen receptor inhibitor, Erleada^®(Apalutamide Tablets, English brand name: Erleada)^®, English generic name: apalutamide) new indication approved by the National Medical Products Administration for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC)^[1]. In September last year, Erleada^®Approved for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (NM-CRPC) at high risk of metastasis. In February this year, Erleada^®The mHSPC indication has once again been granted “Priority Review” status by the National Medical Products Administration. Approval of this indication is expected to address the urgent unmet medical needs of patients with advanced prostate cancer in China.

Over the past decade, the incidence of prostate cancer in China has continued to rise, making it the most common genitourinary tumor among Chinese men [2] and ranking fourth among all male malignancies.³. It is estimated that there are 56,600 new cases of prostate cancer annually among individuals aged 60 years and older in China.[3] With the intensifying aging of China’s population[4], the incidence of prostate cancer is projected to continue rising.

Prostate cancer is also described as a “silent killer” because it is difficult to detect in its early stages. In China, most patients are diagnosed at an advanced stage, with 54% already having developed bone metastases at the time of presentation [5]. The majority of newly diagnosed patients with metastatic prostate cancer in China are in the metastatic hormone-sensitive prostate cancer (mHSPC) stage. mHSPC refers to prostate cancer that has spread to other parts of the body and remains responsive to androgen deprivation therapy (including surgical castration and medical castration) [6]. Patients at this disease stage face a higher risk of mortality [7], and both treatment prognosis and quality of life are suboptimal.

Professor Ye Dingwei from Fudan University Shanghai Cancer Center pointed out, “Once prostate cancer metastasizes, the difficulty of treatment significantly increases, and the traditional endocrine therapy currently used needs further optimization. According to the TITAN study, for patients with mHSPC, Ansenke”^®Combined androgen deprivation therapy (ADT) can provide survival benefits for patients with metastatic prostate cancer. Even if metastasis has been detected, patients should not lose hope. Early treatment leads to early benefits; active management can help delay disease progression, prolong survival, and improve quality of life.”

The TITAN study is a randomized, double-blind, placebo-controlled, international, multicenter Phase 3 clinical trial. The study results showed that, compared with placebo combined with ADT therapy, Erleada^®Combined ADT significantly prolonged overall survival in patients with metastatic hormone-sensitive prostate cancer (mHSPC), reducing the risk of death by 33% (HR=0.67; 95% CI, 0.51-0.89; P=0.0053) and the risk of radiographic progression or death by 52% (HR=0.48; 95% CI, 0.39-0.60; P<0.0001).¹

Based on the confirmed efficacy and safety demonstrated in the TITAN study, the European Association of Urology (EAU) guidelines and the National Comprehensive Cancer Network (NCCN) guidelines recommend apalutamide, a novel anti-androgen agent, in combination with androgen deprivation therapy (ADT) as one of the treatment options for metastatic hormone-sensitive prostate cancer (mHSPC). With these updates to international guidelines, mHSPC has entered the era of novel endocrine therapy.

Dr. Peter Lebowitz, Head of Global Oncology Research and Development at Janssen, stated: “Regardless of the patient’s disease severity or prior docetaxel treatment history, ERLEADA^®has the potential to transform the treatment of prostate cancer patients, helping them delay disease progression and extend survival. This milestone underscores Janssen’s commitment to patients in China, as we remain dedicated to continuously improving the diagnosis and treatment landscape for prostate cancer and developing innovative solutions for patients at all stages of the disease.”

Dr. Li Zili, Head of Janssen Asia-Pacific R&D, stated, “We recognize that not all prostate cancers are the same. To address the treatment challenges of prostate cancer at different disease stages, we continuously explore the clinical potential of innovative solutions. We are pleased to bring another important new treatment option to patients with prostate cancer in China, meeting their growing treatment needs.”

Asgar Rangoonwala, President of Xian Janssen Pharmaceutical Ltd., stated, “With 35 years of deep commitment to China, Xian Janssen has always focused on patients’ medical needs across all stages of prostate cancer. Erleada^®With Zytiga^®(Abitirone Acetate Tablets) have helped transform the treatment landscape for prostate cancer, improving patients' quality of life. In the future, we will continue to collaborate closely with government authorities and industry stakeholders to enhance access to innovative medicines, fulfilling our commitment to patients in China and ensuring that every breakthrough in new drug development benefits each patient more rapidly.

Erleada^®is Xian Janssen’s second innovative solution for the treatment of prostate cancer. Previously, Zytiga^®Approved in 2015 and 2018, respectively, for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer (mCRPC), and in combination with prednisone or prednisolone for the treatment of newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC).

- End -

About Xian Janssen

Xian Janssen Pharmaceutical Ltd. is the pharmaceutical subsidiary of Johnson & Johnson in China. At Xian Janssen, we are committed to creating a world free of disease. Our goal of preventing, interrupting, and treating diseases in newer and better ways has always inspired us. We bring together advanced concepts and pursue scientific achievements with promising prospects. We are Xian Janssen. Joining hands with the world, we build health together.

For more information about Xian Janssen Pharmaceutical Ltd., please visit our website at www.xian-janssen.com.cn or follow our WeChat official account: Xian Janssen.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding ERLEADA^®(apalutamide tablets) provisions. Readers are 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 if known or unknown risks or uncertainties materialize, actual results may differ materially from the expectations and projections of Xian Janssen Pharmaceutical Ltd., any other Janssen Pharmaceutical company, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the challenges and uncertainties inherent in product development, including uncertainty regarding clinical success and regulatory approval; uncertainty regarding commercial success; manufacturing difficulties and delays; competition, including technological advances and new products and patents obtained by competitors; challenges to patents; product efficacy or safety issues resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of healthcare products and services; changes in applicable laws and regulations, including global healthcare reform; and trends toward healthcare cost containment. A further list and description 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 30, 2018 (including the sections titled “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors”), in the Company’s most recently filed Quarterly Reports on Form 10-Q, and in the Company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov and www.jnj.com, or upon request from Johnson & Johnson. Neither Janssen nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

In accordance with the Drug Administration Law and other relevant legal provisions, prescription drugs may only be dispensed, purchased, and used upon presentation of a valid prescription issued by a licensed physician or licensed assistant physician. For over-the-counter (OTC) drugs, consumers have the right to make independent selections and must use them in strict accordance with the information provided on the OTC drug labels and package inserts. This press release discloses factual information involving general scientific knowledge, intended solely for reference by healthcare professionals, and does not constitute any recommendation for purchase or use.

[1] Apalutamide Tablets Package Insert (2020)

[2] China Cancer Registry Annual Report 2012

[3] China Cancer Statistics.2015

[4] 2015-2020 China Health Checkup Industry Market Panorama Evaluation and Investment Strategy Advisory Report.2015

[5] Ma Chunguang etc. Prostate Cancer Epidemical Features and Advanced First-line Hormonal Therapy Analysis. Chinese Journal of Surgery. 2008;46(12):921-925.

[6] American Society of Clinical Oncology. Prostate Cancer: Treatment Options. http://www.cancer.net/cancer-types/prostate-cancer/treatment-options. Accessed February 2018.

[7] Supplement: Scher HI, Solo K, Valant J, Todd MB, Mehra M et al. Prevalence of Prostate Cancer Clinical States and Mortality in the United States: Estimates Using a Dynamic Progression Model. PLoS One. 2015; 10(10): 1-2.