What is the therapeutic effect of Bayer Zydus version of Darolutamide in India?
Darolutamide is a novel androgen receptor inhibitor primarily used for the treatment of non metastatic castration resistant prostate cancer (nmCRPC). Its therapeutic effect is mainly reflected in significantly prolonging metastasis free survival (MFS), with good safety and low incidence of adverse reactions. The following will explain from the aspects of indications, clinical efficacy, and safety.
1 Indications
Daretamide is suitable for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) patients and should be used in combination with androgen deprivation therapy (ADT). This drug delays disease progression to the metastatic stage by inhibiting the androgen receptor signaling pathway.
2 Clinical efficacy
(1) Non metastatic survival (MFS): The key Phase III ARAMIS study showed that the median MFS in the darotamine group was 40.4 months, significantly prolonged by 22 months compared to the placebo group (18.4 months), and reduced the risk of metastasis by 59%.
(2) Overall survival (OS): Follow up data showed a 31% reduction in mortality risk and an increase in 3-year survival rate to 83% in the darotamine group (77% in the placebo group).
3 Security Advantages
(1) Common adverse reactions include fatigue (16%), limb pain (6%), and rash (3%), most of which are grade 1-2.
(2) Compared with other AR inhibitors, the incidence of central nervous system related adverse events such as epilepsy and falls is lower (<0.5%).
(3) There is no significant increase in the risk of cardiovascular events, making it suitable for elderly patients with concomitant cardiovascular diseases.
4. Medication for special populations
(1) Liver function impairment: Mild to moderate impairment does not require dose adjustment, and patients with severe impairment should use with caution.
(2) Renal dysfunction: Patients with varying degrees of renal dysfunction do not require dose adjustment.
(3) Elderly medication: Patients over 65 years old do not need to adjust the dosage, but adverse reactions need to be closely monitored.
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