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Prostate Cancer
FDA Accelerates Approval of Akeega, the First Dual-Action Tablet for BRCA-Mutated Metastatic Prostate Cancer
FDA Approvals, News & Updates
,
Prostate Cancer
October 2023, Vol 14, No 5
On
August 11, 2023
, the FDA accelerated the approval of the fixed-dose combination of niraparib and abiraterone acetate (Akeega; Janssen Biotech), with prednisone, for the treatment of adults with deleterious or suspected deleterious
BRCA
-mutated, castration-resistant prostate cancer, as determined by an FDA-approved test. The FDA granted this approval priority review.
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Talzenna Receives New Indication, With Enzalutamide, for Metastatic Castration-Resistant Prostate Cancer With HRR Gene Mutation
FDA Approvals, News & Updates
,
Prostate Cancer
August 2023, Vol 14, No 4
On
June 20, 2023
, the FDA approved a new indication for talazoparib (Talzenna; Pfizer), a poly (ADP-ribose) polymerase inhibitor, in combination with enzalutamide (Xtandi; Astellas) for homologous recombination repair (
HRR
) gene mutation–positive, metastatic castration-resistant prostate cancer. The FDA granted this application priority review.
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New Subgroup Analysis Confirms Efficacy and Safety of Darolutamide Across Different Subgroups of Patients with Metastatic Hormone-Sensitive Prostate Cancer
By
Anne Rowe
ASCO GU 2023 HIGHLIGHTS
,
Prostate Cancer
,
Genitourinary Cancers
April 2023, Vol 14, No 2
An analysis from the ARASENS trial showed that the addition of darolutamide to androgen-deprivation therapy and docetaxel significantly improved overall survival in subgroups of patients with metastatic hormone-sensitive prostate cancer with high-volume and high-risk disease and should be considered the new standard of care for this patient population.
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Shortened Course of Radiotherapy Feasible in Men with High-Risk Prostate Cancer
By
Phoebe Starr
Prostate Cancer
,
ASTRO Meeting Highlights
December 2022, Vol 13, No 6
A shortened course of radiation therapy is safe and effective for men with high-risk prostate cancer, according to the results of the phase 3 Prostate Cancer Study 5 (PCS5) trial. These findings were presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2022 by the study’s lead investigator Tamim M. Niazi, MD, Associate Professor, Radiation Oncology, and Radiation Oncologist, Jewish General Hospital, McGill University, Montréal, Québec, Canada.
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Niraparib plus Abiraterone Combination Extends PFS in Men with CRPC and HRR Gene Mutations
By
Phoebe Starr
Prostate Cancer
August 2022, Vol 13, No 4 Online Only
The addition of the PARP inhibitor niraparib (Zejula) to abiraterone acetate (Zytiga) plus prednisone (AAP) led to a significant improvement in radiographic progression-free survival (PFS) versus AAP alone in men with metastatic castration-resistant prostate cancer (mCRPC) harboring homologous recombination repair (HRR) gene alterations, according to the final analysis of the primary end point of a phase 3 trial.
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Darolutamide plus ADT and Docetaxel Improves Survival in Men with Metastatic Hormone-Sensitive Prostate Cancer
By
Wayne Kuznar
Prostate Cancer
June 2022, Vol 13, No 3
Treatment with the androgen receptor inhibitor darolutamide (Nubeqa), in combination with androgen-deprivation therapy (ADT) and docetaxel, significantly improved overall survival (OS) compared with ADT and docetaxel alone in patients with metastatic hormone-sensitive prostate cancer (mHSPC), according to recent results from the phase 3 ARASENS clinical trial, which were simultaneously published in the New England Journal of Medicine.
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Genetic Score Makes PSA Screening More Accurate
By
Phoebe Starr
Prostate Cancer
June 2022, Vol 13, No 3
The use of a polygenic score (PGS) based on noncancer genetic variations in prostate-specific antigen (PSA) values helped to refine PSA screening in a large group of men without prostate cancer at baseline. The use of the PGS to adjust PSA allows identification of aggressive versus low-risk prostate cancer and can potentially reduce unnecessary biopsies, said the lead investigator of a large genome-wide association study (GWAS) presented at the 2022 American Association for Cancer Research annual meeting.
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Abiraterone plus Prednisone Added to ADT Boosts Survival in Patients with High-Risk Prostate Cancer
By
Phoebe Starr
Prostate Cancer
February 2022, Vol 13, No 1 Online Only
Two years of abiraterone acetate (Zytiga) plus prednisone added to androgen-deprivation therapy (ADT) improved metastasis-free survival and overall survival compared with ADT alone in men with nonmetastatic castration-sensitive prostate cancer, whereas the addition of enzalutamide (Xtandi) to ADT had no benefit, and much greater toxicity.
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¹⁷⁷Lu-PSMA-617 Prolongs Survival in Patients with Metastatic Castration-Resistant Prostate Cancer
By
Phoebe Starr
ASCO 2021 Highlights
,
Prostate Cancer
August 2021, Vol 12, No 4
The addition of
177
Lu-PSMA-617, a radionuclide therapy that targets prostate-specific membrane antigen (PSMA), to standard-of-care treatment resulted in a 38% reduction in the risk for death versus standard of care alone in men with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), according to findings from the phase 3 VISION clinical trial, which were presented during a plenary session at the ASCO 2021 virtual annual meeting.
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Orgovyx First FDA-Approved Oral Hormone Therapy for Advanced Prostate Cancer
FDA Approvals, News & Updates
,
Prostate Cancer
February 2021, Vol 12, No 1
On
December 18, 2020
, the FDA approved relugolix (Orgovyx; Myovant Sciences), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of adults with advanced prostate cancer. Relugolix is the first oral androgen-deprivation therapy (ADT) and the first oral GnRH receptor antagonist approved for patients with advanced prostate cancer. The FDA granted relugolix priority review for this indication.
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