SUMMARY

• No data evaluating the efficacy and safety of ERLEADA in patients with active infections, including novel coronavirus disease 2019 (COVID-19), have been published. In addition, no published data were identified regarding the use of a COVID-19 vaccine in patients receiving ERLEADA. For more information on the use of vaccines and treatments for COVID-19, please contact the product manufacturers directly.
• Patients receiving ERLEADA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.^1-4 For more information regarding GnRH analog therapy, please contact the manufacturer directly.
• Data to assess incidence and mortality of COVID-19 in patients with cancer, including patients with prostate cancer receiving androgen deprivation therapy (ADT), have been published.^5,6

COVID-19 Prophylaxis or Infection in Patients Receiving ERLEADA

• If a patient is suspected to have been exposed to COVID-19, but is asymptomatic, providers should follow local and institutional guidelines to weigh risk vs benefit of the individual patient’s treatment with ERLEADA based on the nature and status of the patient’s underlying cancer, comorbidities, concomitant medications, and the potential risks associated with COVID-19 infection.
• For prophylaxis, or if a patient has a confirmed COVID-19 infection, physicians should consider the risk vs benefit of continuing ERLEADA based on the nature and status of the patient’s underlying cancer, comorbidities, and the potential risks associated with the COVID-19 infection. Providers should refer to product labeling for additional information, including pharmacokinetics, safety, dosage & administration, dose modifications, monitoring, and drug-drug interactions for other medications used concomitantly in the prevention or management of COVID-19 infection.

Select COVID-19 Resources for Providers Treating Patients with Cancer

Please note: this is not a complete list of publicly available resources pertaining to this topic.

• The Centers for Disease Control and Prevention (CDC) provides clinical care considerations for clinicians caring for patients with confirmed infection and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).⁷ Additionally, the National Institutes of Health (NIH) provides considerations and guidance for specific populations, including patients with cancer, and notes these patients may be at increased risk for severe illness.⁸
  • Interventions should be based on patient presentation and the clinical judgment of the treating physician. For the latest information from the CDC, visit: COVID-19.
• The American Cancer Society (ACS) and the American Society of Clinical Oncology (ASCO) recognize that cancer patients and cancer survivors often have weakened immune systems, increasing their risk for serious illness from infections such as the coronavirus. ASCO recommends that oncologists and health care teams should discuss with their patients how best to protect against infections, such as coronavirus.^9,10
• ASCO advises oncologists to use the best available evidence in caring for patients who may be exposed to or infected with the coronavirus, referring to the following as general sources of information: Journal of American Medical Association (JAMA), New England Journal of Medicine (NEJM), U.S. Food and Drug Administration (FDA), and U.S. CDC.¹¹ ASCO has also developed resources related to caring for patients with cancer in the context of the coronavirus pandemic for clinicians and the cancer care delivery team¹², visit: ASCO Coronavirus Resources.
• Additional cancer organizations, including the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO), have published resources for healthcare professionals, visit: NCCN COVID-19 Resources and ESMO COVID-19 and Cancer.
• For the latest global information and guidance from the World Health Organization (WHO) regarding the current outbreak of coronavirus (COVID-19), including daily updates, visit: Coronavirus Disease (COVID-19) Pandemic.

Clinical data

Phase 3 TITAN Study

Chi et al (2019)¹ evaluated the efficacy and safety of ERLEADA plus ADT compared to placebo plus ADT in patients with metastatic castration-sensitive prostate cancer (mCSPC; N=1052). Patients were randomized 1:1 to receive either ERLEADA 240 mg orally once daily (n=525) or placebo once daily (n=527). All patients in the TITAN study received a concomitant GnRH analog or had a bilateral orchiectomy. Patients were excluded if there was evidence of active infection requiring systemic therapy such as human immunodeficiency virus (HIV).²

COVID-19 Infections

Three patients (1.4%) in the crossover (placebo to ERLEADA plus ADT) group reported COVID-19 treatment-emergent adverse events, which resolved and did not lead to treatment discontinuation or death.¹³

Non-COVID-19 Infections

Investigator-reported cause of death in the safety population included sepsis and urosepsis in zero patients in the ERLEADA group and in 1 patient (0.2%) each in the placebo group.¹⁴ Incidence of infections leading to treatment discontinuation or dose interruption is shown below.

Efficacy and safety analyses were not performed for patients with a concurrent infection in the TITAN study.

Phase 3 SPARTAN Study

Smith et al (2018)³ evaluated the efficacy and safety of ERLEADA in patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC; N=1207). Patients were randomized 2:1 to receive either ERLEADA 240 mg orally once daily (n=806) or placebo once daily (n=401). All patients in the SPARTAN study received a concomitant GnRH analog or had a bilateral orchiectomy. Patients were excluded if they had history or evidence of an active infection, such as HIV.⁴

Non-COVID-19 Infections

Of the 8 patients who died due to ERLEADA-related toxicity, 4 were due to infection.¹⁵ Incidence of infections leading to treatment discontinuation or dose interruption is shown below.

Efficacy and safety analyses were not performed for patients with a concurrent infection in the SPARTAN study.

Additional information regarding the SPARTAN study, including the clinical study report, protocol, and statistical analysis plan, can be found: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/Erleada_210951_toc.cfm (scroll to the “Sponsor Clinical Study Reports ARN-509-003 SPARTAN NCT # 01946204” section at the bottom of the web page).

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 29 August 2024.