J&J递交非转移性去势抵抗性前列腺癌Apalutamide注册申请@FDA

#JNJ

Abiraterone专利到期后

JNJ在前列腺癌领域

受到Medivation（Pfizer）的Enzalutamide冲击

也是需要一款新药挽回市场份额

Apalutamide（ARN-509）

用于早期的去势抵抗性前列腺癌

目前FDA尚未批准一款用于非转移性CRPC治疗药物

这也算是1st了

该申请基于此前的III期临床ARN-509-003 (SPARTAN)

具体试验结果将在后续会议中公布

JNJ为了Apalutamide收购Argon

又去跟Tesaro谈下来了

Niraparib在前列腺癌治疗领域的开发权

真的是打算啃下这个市场了

从早期到晚期

Apalutamide Niraparib Abiraterone

JNJ-7107 JNJ-1809

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HORSHAM, PA, October 11, 2017 – Janssen Biotech, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apalutamide, an investigational, next generation oral androgen receptor (AR) inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC). Currently, there are no FDA approved treatments for patients with non-metastatic CRPC.

This submission is based on Phase 3 data from the pivotal ARN-509-003 (SPARTAN) clinical trial, which assessed the safety and efficacy of apalutamide versus placebo, in men with non-metastatic CRPC who have a rapidly rising prostate specific antigen (PSA) despite receiving continuous androgen deprivation therapy (ADT).[1] Men with non-metastatic CRPC with a rapidly rising PSA are at high-risk for developing metastatic disease.[2],[3] The primary endpoint of this study was metastasis free survival (MFS).1 MFS is the time from randomization to first evidence of confirmed metastasis, or time to death.[4] The SPARTAN study results will be presented at a future medical meeting.

“The SPARTAN data lead the path towards a new approach to treating men with prostate cancer earlier in the disease course. We have demonstrated that treating patients before the disease has metastasized improves outcomes,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head of Oncology at Janssen. “We are thrilled to have completed our submission of the SPARTAN data to the FDA and we look forward to a promising treatment that can provide new hope and expectations for men facing this disease.”

Prostate cancer is the most common cancer among American men, other than skin cancer.[5] According to the American Cancer Society, more than 161,000 men are estimated to be diagnosed with prostate cancer in 2017.5 Patients with non-metastatic prostate cancer receiving ADT will eventually become resistant to ADT, developing castration-resistant prostate cancer (CRPC). Data has estimated 10% to 20% of patients diagnosed with prostate cancer may develop CRPC within approximately 5 years.[6]

Non-metastatic castration-resistant prostate cancer refers to patients with CRPC who lack detectable distant metastatic disease.[7],[8] These individuals have a rising PSA, testosterone level below 50 ng/dl and bone scan and CT scans that show no evidence of spread to bones or visceral organs.[9] Men with rapidly rising PSA have a high unmet medical need, as these patients are at high-risk for developing metastatic disease.[10]