Supplemental New Drug Application Supported by Phase 3 TITAN Study; Submitted Through FDA Real-Time Oncology Review Program
RARITAN, NJ, USA I April 29, 2019 I The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new indication for ERLEADA® (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). The sNDA is based on findings from the Phase 3 TITAN study, whose dual primary endpoints, overall survival (OS) and radiographic progression-free survival (rPFS), were both achieved. These data will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting during an oral abstract session on Friday, May 31st.
The sNDA is being reviewed by the FDA through the Real-Time Oncology Review (RTOR) program, which for certain applications allows the FDA to review data before the applicant formally submits the complete application. The program aims to explore a more efficient review process to help ensure treatments are available for patients as soon as possible. Selection into the RTOR program does not guarantee or influence approvability of the application.
“This submission marks an important step in providing a potential treatment option for patients with metastatic castration-sensitive prostate cancer, regardless of prior treatment or the extent of their disease,” said Craig Tendler, M.D., Vice President, Oncology Clinical Development and Medical Affairs, Janssen Research & Development, LLC. “We look forward to closely collaborating with the FDA through the efficient Real-Time Oncology Review pilot program with the goal of bringing ERLEADA to an earlier population of patients with metastatic prostate cancer as soon as possible.”
About the TITAN Study1
TITAN (NCT02489318) is a Phase 3 randomized, placebo-controlled, double-blind study in patients with mCSPC regardless of extent of disease, and prior treatment with docetaxel or treatment of localized disease. More than 1,050 patients with mCSPC were randomized to receive either ERLEADA plus androgen deprivation therapy (ADT), or placebo plus ADT. The TITAN study included mCSPC patients with both low and high-volume disease, those who were newly diagnosed or those who have received prior definitive local therapy, or prior treatment with up to six cycles of docetaxel. Participants were treated until disease progression or the occurrence of unacceptable treatment related toxicity, or end of treatment. The dual primary endpoints of the study are OS and rPFS. Secondary endpoints include time to chemotherapy, time to pain progression, time to chronic opioid use and time to skeletal related event.1 For additional study information, visit ClinicalTrials.gov.
About ERLEADA
ERLEADA® (apalutamide) is an androgen receptor (AR) inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). It became the first treatment to receive FDA approval for this disease state on February 14, 2018.2 The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer include apalutamide as a treatment option for patients with non-metastatic (M0) CRPC with a category 1 recommendation for those with a PSA doubling time ≤10 months*.3 Additionally, the American Urological Association (AUA) Guidelines for Castration-Resistant Prostate Cancer (CRPC) were updated to include apalutamide (ERLEADA) with continued ADT as a treatment option that clinicians should offer to patients with asymptomatic nmCRPC. It is included as one of the options clinicians should offer to patients with nmCRPC who are at high-risk for developing metastatic disease (Standard; Evidence Level Grade A)**.4
*Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2019. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed April 23, 2019. To view the most recent and complete version of the NCCN Guidelines®, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way.
**Standard: Directive statement that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be taken based on Grade A or B evidence.
**Evidence Level: A designation indicating the certainty of the results as high, moderate, or low (A, B, or C, respectively) based on AUA nomenclature and methodology.
About Metastatic Castration-Sensitive Prostate Cancer
Metastatic prostate cancer is cancer that has spread to another part of the body.5 Metastatic castration-sensitive prostate cancer (mCSPC), refers to prostate cancer that still responds to androgen deprivation therapy (ADT).5 Patients with mCSPC tend to have a poor prognosis, with a median OS of less than five years, underscoring the need for new treatment options.6,7,8
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC and Janssen Biotech, Inc. are members of the Janssen Pharmaceutical Companies of Johnson & Johnson.
1 ClinicalTrials.gov. A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC (TITAN). Available at: https://clinicaltrials.gov/ct2/show/NCT02489318. Accessed April 2019.
2 ERLEADA Prescribing Information, February 2018.
3 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed March 12, 2018. To view the most recent and complete version of the NCCN Guidelines®, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way.
4 American Urological Association. Castration-Resistant Prostate Cancer Guidelines. http://www.auanet.org/guidelines/castration-resistant-prostate-cancer-(2013-amended-2018). Accessed April 2019.
5 American Society of Clinical Oncology. Prostate Cancer: Treatment Options. http://www.cancer.net/cancer-types/prostate-cancer/treatment-options. Accessed April 2019.
6 American Cancer Society. Survival rates for prostate cancer. https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/survival-rates.html. Accessed April 2019.
7 Fizazi K., et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. New England Journal of Medicine. June 2017.
8 Crawford ED, Higano CS, Shore ND, et al. : Treating patients with metastatic castration resistant prostate cancer: A comprehensive review of available therapies. J Urol 194:1537-1547, 2015.
SOURCE: Janssen
Post Views: 220
Supplemental New Drug Application Supported by Phase 3 TITAN Study; Submitted Through FDA Real-Time Oncology Review Program
RARITAN, NJ, USA I April 29, 2019 I The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new indication for ERLEADA® (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). The sNDA is based on findings from the Phase 3 TITAN study, whose dual primary endpoints, overall survival (OS) and radiographic progression-free survival (rPFS), were both achieved. These data will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting during an oral abstract session on Friday, May 31st.
The sNDA is being reviewed by the FDA through the Real-Time Oncology Review (RTOR) program, which for certain applications allows the FDA to review data before the applicant formally submits the complete application. The program aims to explore a more efficient review process to help ensure treatments are available for patients as soon as possible. Selection into the RTOR program does not guarantee or influence approvability of the application.
“This submission marks an important step in providing a potential treatment option for patients with metastatic castration-sensitive prostate cancer, regardless of prior treatment or the extent of their disease,” said Craig Tendler, M.D., Vice President, Oncology Clinical Development and Medical Affairs, Janssen Research & Development, LLC. “We look forward to closely collaborating with the FDA through the efficient Real-Time Oncology Review pilot program with the goal of bringing ERLEADA to an earlier population of patients with metastatic prostate cancer as soon as possible.”
About the TITAN Study1
TITAN (NCT02489318) is a Phase 3 randomized, placebo-controlled, double-blind study in patients with mCSPC regardless of extent of disease, and prior treatment with docetaxel or treatment of localized disease. More than 1,050 patients with mCSPC were randomized to receive either ERLEADA plus androgen deprivation therapy (ADT), or placebo plus ADT. The TITAN study included mCSPC patients with both low and high-volume disease, those who were newly diagnosed or those who have received prior definitive local therapy, or prior treatment with up to six cycles of docetaxel. Participants were treated until disease progression or the occurrence of unacceptable treatment related toxicity, or end of treatment. The dual primary endpoints of the study are OS and rPFS. Secondary endpoints include time to chemotherapy, time to pain progression, time to chronic opioid use and time to skeletal related event.1 For additional study information, visit ClinicalTrials.gov.
About ERLEADA
ERLEADA® (apalutamide) is an androgen receptor (AR) inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). It became the first treatment to receive FDA approval for this disease state on February 14, 2018.2 The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer include apalutamide as a treatment option for patients with non-metastatic (M0) CRPC with a category 1 recommendation for those with a PSA doubling time ≤10 months*.3 Additionally, the American Urological Association (AUA) Guidelines for Castration-Resistant Prostate Cancer (CRPC) were updated to include apalutamide (ERLEADA) with continued ADT as a treatment option that clinicians should offer to patients with asymptomatic nmCRPC. It is included as one of the options clinicians should offer to patients with nmCRPC who are at high-risk for developing metastatic disease (Standard; Evidence Level Grade A)**.4
*Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2019. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed April 23, 2019. To view the most recent and complete version of the NCCN Guidelines®, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way.
**Standard: Directive statement that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be taken based on Grade A or B evidence.
**Evidence Level: A designation indicating the certainty of the results as high, moderate, or low (A, B, or C, respectively) based on AUA nomenclature and methodology.
About Metastatic Castration-Sensitive Prostate Cancer
Metastatic prostate cancer is cancer that has spread to another part of the body.5 Metastatic castration-sensitive prostate cancer (mCSPC), refers to prostate cancer that still responds to androgen deprivation therapy (ADT).5 Patients with mCSPC tend to have a poor prognosis, with a median OS of less than five years, underscoring the need for new treatment options.6,7,8
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC and Janssen Biotech, Inc. are members of the Janssen Pharmaceutical Companies of Johnson & Johnson.
1 ClinicalTrials.gov. A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC (TITAN). Available at: https://clinicaltrials.gov/ct2/show/NCT02489318. Accessed April 2019.
2 ERLEADA Prescribing Information, February 2018.
3 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed March 12, 2018. To view the most recent and complete version of the NCCN Guidelines®, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way.
4 American Urological Association. Castration-Resistant Prostate Cancer Guidelines. http://www.auanet.org/guidelines/castration-resistant-prostate-cancer-(2013-amended-2018). Accessed April 2019.
5 American Society of Clinical Oncology. Prostate Cancer: Treatment Options. http://www.cancer.net/cancer-types/prostate-cancer/treatment-options. Accessed April 2019.
6 American Cancer Society. Survival rates for prostate cancer. https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/survival-rates.html. Accessed April 2019.
7 Fizazi K., et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. New England Journal of Medicine. June 2017.
8 Crawford ED, Higano CS, Shore ND, et al. : Treating patients with metastatic castration resistant prostate cancer: A comprehensive review of available therapies. J Urol 194:1537-1547, 2015.
SOURCE: Janssen
Post Views: 220
