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Erleada® reduces prostate-specific antigen (PSA) by 86 percent
Erleada achieved an 86 percent reduction in PSA at 12 months in the majority of patients, shows post-hoc analysis of Phase III study.
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Collaboration and integration to progress clinical research
Here, Lucinda Cash-Gibson and Francesco Patalano discuss why the pharmaceutical industry is collaborating to develop protocols for patient-centric integrated platform trials and what the clinical research industry may look like in future.
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Proxalutamide reduces COVID-19 mortality risk by 92 percent
In a Phase III trial, Proxalutamide reduced mortality and expedited recovery of hospitalised COVID-19 patients in Brazil.
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First patient dosed with therapeutic prostate cancer vaccine
The trial will evaluate the safety, tolerability and immunogenicity of Ultimovacs’ prostate cancer-specific therapeutic TET-based vaccine.
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Novel prostate cancer drug formulation could improve drug’s efficacy
A new oil-based oral formulation of prostate cancer drug abiraterone acetate could enable a smaller dose of the drug to be effective and reduce possible side effects, a study has shown.
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EMA recommends updating safety information for HRT and leuprorelin
The EMA has suggested that the safety information be updated for HRT, to reflect a higher risk of breast cancer and recommends new measures for the handling of leuprorelin depot medicines.
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Five of the most recent developments in anti-cancer therapeutics
European Pharmaceutical Review investigates five of the latest cancer drug approvals and clinical trial results.
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EMA announces restrictions to cyproterone use due to meningioma risk
After a review of cyproterone, the EMA has recommended that the drug only be prescribed once other treatment options have failed, due to an increased meningioma risk.
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CHMP recommends fifteen therapeutics at latest meeting
The EMA’s human medicines committee (CHMP) recommended fifteen medicines for various approvals at its January 2020 meeting; with ten drugs receiving marketing authorisation recommendations and five receiving positive opinions for specific treatments.
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Ninety-seven percent response rate reported in advanced prostate cancer treatment study
A Phase III study of oral relugolix has met its primary efficacy endpoint in men with advanced prostate cancer, supporting a New Drug Application submission to the FDA.
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Breakthrough Therapy Designation granted to prostate cancer drug
The FDA has given the designation to niraparib for the treatment of gene-mutated castration-resistant prostate cancer.
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XTANDI® treatment granted priority review by FDA
XTANDI® sNDA seeks to add an indication for men with prostate cancer that's spread but is sensitive to hormone therapy.
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US appeals court overturns patent case for Jevtana
Sanofi has won the latest appeal for the patent of its top oncology product, Jevtana (cabazitaxel).
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Amgen and Astellas Pharma US agree to settlement costs for kickback charges
Amgen and Astellas Pharma US have agreed to pay a total of $124.75 million to settle allegations that they paid kickbacks to Medicare copays for their own medications.
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Phase III combination trial improves survival in men with metastatic prostate cancer
A Phase III clinical trial has shown that metastatic prostate cancer improved through the use of a combination therapy with enzalutamide...