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EMA human medicines committee (CHMP) meeting highlights, March 2022
The March meeting saw the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommend five medications for approval including a multiple myeloma gene therapy.
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Prostate cancer
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EMA’s human medicines committee (CHMP) Feb meeting highlights
Highlights of the February 2022 meeting of EMA’s human medicines committee (CHMP) include the recommendation of 13 medicines for approval, along with updates to other drugs and COVID-19 vaccines.
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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).