FDA approves Bayer Nubeqa prescription information update: Phase 3 clinical significantly extended lifetime

Bayer recently announced that the U.S. Food and Drug Administration (FDA) has approved a new drug application (sNDA) for nubeqa (darolutamide), a new drug for prostate cancer, adding total lifetime (OS) and other secondary endpoint data from key Phase 3 ARAMIS study trials to Nubeqa's prescription information.
data show that nubeqa significantly reduced the risk of death by 31% and extended the survival of patients with non-metastatic desopathic prostate cancer (nmCRPC) compared to placebo.
other data include the time of pain progress and the time of initiating cytotoxyte chemotherapy.
guidance, including drug interactions, has also been included in the prescription information.
final analysis of a mid-29-month extended follow-up of the entire study population strengthened Nubeqa's security.
, developed by Bayer in partnership with Finnish pharmaceutical company Orion, has been approved in the United States, the European Union and several other countries for the treatment of male patients with nmCRPC.
The drug is an oral nonsteroidal androgen inhibitor (AR) inhibitor with a unique chemical structure that binds the subject with high affinity and exhibits strong antagonist activity, thereby inhibiting the function of the subject and the growth of prostate cancer cells.
nubeqa does not cross the blood-brain barrier, so there are fewer potential drug interactions and central nervous side effects such as epilepsy, falls and cognitive impairments, unlike other existing nmCRPC treatments.
A key goal of cancer treatment is to prolong patient life while minimizing side effects," said Dr. Scott Z. Fields, Senior Vice President and Head of Oncology Development at Bayer Pharmaceuticals.
Nubeqa has proven efficacy and safety in male patients with nmCRPC and delays the progression of the disease in male patients who are usually asymptomatic.
this update also gives doctors greater confidence that Nubeqa should be prescribed to the right patients when the nmCRPC diagnosis is made to help ensure the best outcomes for these patients.
" ARAMIS was a randomized, multi-center, double-blind, placebo-controlled Phase III trial that included 1,509 male nmCRPC patients who were receiving androgen deprivation therapy (ADT) and were at high risk of metastasis.
study assessed the efficacy and safety of oral Nubeqa and placebos.
the study, patients were randomly assigned 2:1 to take 600 mg Nubeqa or placebo twice a day or orally, as well as ADT.
study allows patients with a history of epilepsy to participate in treatment.
's previously published primary efficacy endpoint data show that nubeqa plus ADT significantly extended the non-transferable lifetime (median MFS: 40.4 months vs. 18.4 months, p<0.0001), significantly reducing the risk of disease metastasis or death by 59% compared to placebo-ADT.
, however, total lifetime (OS) data is not yet mature for final MFS analysis.
the final OS analysis of the study was published in the New England Journal of Medicine (NEJM) in September 2020.
results showed that Nubeqa significantly prolonged OS, significantly delayed the on-the-appearance of cancer-related symptoms, and minimized toxicity compared to placebos.
(see: Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide: Nubeqa plus ADT significantly reduced the risk of death by 31% (HR=0.69; 95% CI:0.53-0.88; p=0.003) compared to placebo-ADT, while significantly delaying pain progression time (HR=0.0) .65,95% CI:0.53-0.79;p<0.0001), time to start the first cytotoxytic chemotherapy (HR=0.58,9 5%CI:0.44-0.76;p<0.0001), the time of the first symptomatic skeletal event (SSE), all of which were statistically significant improvements.
It's worth noting that while more than half (55 percent, 307 out of 554 patients) in the placebo-ADT treatment group had switched to Nubeqa (31,170) or another life-extending treatment by the deadline for final analysis (November 15, 2019), significant OS benefits were also observed.
continued to show good safety after a mid-29-month extended follow-up of the entire study population.
, there was no change in discontinuation of treatment due to adverse reactions (AE) compared to earlier analyses, which occurred in 9% of patients in both groups.
new analysis of the ARAMIS study also confirms that Nubeqa's joint ADT has little effect on the central nervous system (CNS) and is less likely to develop mental and cognitive impairment.
the low blood-brain barrier pass rate observed by Nubeqa in preclinical studies and healthy people could explain this phenomenon.
Prostate cancer (photo source: hopkinsmedicine.org) .png Globally, prostate cancer is the second most common malignant tumor and the fifth leading cause of cancer death among men, affecting men over 50 years of age and increasing the risk as they age.
desopathic resistance to prostate cancer (CRPC) is prostate cancer that continues to develop when testosterone drops to very low levels in the body.
about one-third of non-metastasis (nmCRPC) patients under transfer within two years, the primary goal of treatment in this case is to delay the metastasis and spread of prostate cancer and limit the side effects of treatment.
Since men with nmCRPC usually have no symptoms and lead active lives, it is important to have treatments that both slow cancer progression and minimize side effects, which will enable them to maintain their lifestyle with little disruption.
Nubeqa will provide an important treatment option for the male patient population of nmCRPC that significantly extends non-transferable survival (MFS) and total lifetime (OS), and the drug has good long-term safety, helping patients to continue treatment and achieve treatment goals.
addition to nmCRPC, Bayer and Orion are also advancing another Phase III clinical study, ARASENS, to assess the efficacy and safety of drarolutamide in treating metastatic hormone-sensitive prostate cancer (mHSPC).
original source: U.S. FDA approves Addition of Overall Survival and Other Secondary Endpoint Data to NUBEQA? (darolutamide) Prescribing Information