Darolutamide tablets is approved by FDA for metastatic hormone-sensitive prostate cancer

August 2022: Darolutamide (Nubeqa, Bayer HealthCare Pharmaceuticals Inc.) tablets combined with docetaxel were approved by the Food and Drug Administration for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).

ARASENS (NCT02799602), a randomised, multicenter, double-blind, placebo-controlled clinical trial involving 1306 patients with mHSPC, served as the foundation for the effectiveness. Patients were randomly assigned to receive either docetaxel plus placebo or darolutamide 600 mg orally twice daily in addition to docetaxel 75 mg/m2 intravenously given every three weeks for up to six cycles. All patients had bilateral orchiectomy or concurrent administration of a gonadotropin-releasing hormone analogue.

The overall survival rate was the main efficacy metric (OS). Another metric for efficacy was the time until pain began to progress. In the darolutamide plus docetaxel arm, the median OS was not attained (NR) (95% CI: NR, NR), whereas in the docetaxel plus placebo arm, the median OS was 48.9 months (95% CI: 44.4, NR) (HR 0.68; 95% CI: 0.57, 0.80; p0.0001). Time to pain progression was statistically significantly delayed by treatment with darolutamide plus docetaxel (HR 0.79; 95% CI: 0.66, 0.95; 1-sided p=0.006).

The patients’ average age ranged from 41 to 89, and 17% of them were 75 or older. The following list of selected demographics was provided: 36% Asian, 4% Black or African American, 52% White, 7% Hispanic/Latino. Patients who had M1a disease (3%) had it spread to distant lymph nodes, 83% had M1b disease (83%), and 14% had M1c disease (spread to organs).

Constipation, a decrease in appetite, a rash, bleeding, a rise in weight, and hypertension were the most frequent adverse effects reported by patients (incidence 10% with a 2% increase above placebo with docetaxel). Anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, elevated ALT, and hypocalcemia were the most prevalent abnormalities seen in laboratory tests (30%).

For mHSPC, a dose of 600 mg (two 300 mg tablets) of darolutamide twice daily with food is advised until intolerable toxicity or disease progression. For up to 6 cycles, docetaxel 75 mg/m2 is intravenously injected every 3 weeks. Within six weeks after the initiation of the darolutamide treatment, the first dosage of docetaxel should be given.

View full prescribing information for Nubeqa.

Nishant Mittal (PhD)

+ postsBio ⮌

Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. His career is marked by significant contributions to stem cell biology, developmental biology, and innovative research techniques.

Research Highlights

Dr. Mittal's research has focused on several key areas:

1) Cardiovascular Development and Regeneration: He studied coronary vessel development and regeneration using zebrafish models1.

2) Cancer Biology: At Dartmouth College, he developed zebrafish models for studying tumor heterogeneity and clonal evolution in pancreatic cancer.
3) Developmental Biology: His doctoral work at Keio University involved identifying and characterizing medaka fish mutants with cardiovascular defects.

4) Stem Cell Research: He investigated the effects of folic acid on mouse embryonic stem cells and worked on cryopreservation techniques for hematopoietic stem cells.

Publications and Presentations

Dr. Mittal has authored several peer-reviewed publications in reputable journals such as Scientific Reports, Cardiovascular Research, and Disease Models & Mechanisms1. He has also presented his research at numerous international conferences, including the Stanford-Weill Cornell Cardiovascular Research Symposium and the Weinstein Cardiovascular Development Conference.

In summary, Dr. Nishant Mittal is a dedicated and accomplished researcher with a strong track record in cardiovascular and cancer biology, demonstrating expertise in various model systems and a commitment to advancing scientific knowledge through innovative research approaches.

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