More Data Support Olaparib-Abiraterone in BRCA-Mutant Prostate Cancer
(MedPage Today) -- Combining olaparib (Lynparza) with abiraterone acetate (Zytiga) as first-line therapy for biomarker-selected patients with metastatic castration-resistant prostate cancer significantly improved progression-free survival (PFS... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - February 15, 2024 Category: Hematology Source Type: news
FDA Approves Akeega for BRCA-Positive Metastatic Prostate Cancer
THURSDAY, Aug. 17, 2023 -- The U.S. Food& Drug Administration has approved Akeega (niraparib and abiraterone acetate) for the treatment of BRCA-positive metastatic castration-resistant prostate cancer.
The approval makes Akeega the first and... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - August 17, 2023 Category: General Medicine Source Type: news
FDA Approves Akeega (niraparib and abiraterone acetate) for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
HORSHAM, Pa., August 11, 2023– The Janssen Pharmaceutical Companies of Johnson& Johnson today announced that the U.S. Food& Drug Administration (FDA) has approved Akeega™ (niraparib and abiraterone acetate), the first-and-only... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 11, 2023 Category: Drugs & Pharmacology Source Type: news
FDA OKs Olaparib-Abiraterone for Metastatic Prostate Cancer
(MedPage Today) -- The FDA has approved the PARP inhibitor olaparib (Lynparza) in combination with abiraterone (Zytiga) for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC), the agency announced Wednesday.
Adult patients should... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - June 1, 2023 Category: American Health Source Type: news
FDA Panel Rejects Broad Olaparib Indication in Metastatic CRPC
(MedPage Today) -- In a near-unanimous vote on Friday, outside advisors to the FDA recommended a narrow indication should the agency approve olaparib (Lynparza) plus abiraterone (Zytiga) as initial treatment for metastatic castration-resistant... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - April 29, 2023 Category: American Health Source Type: news
With negative FDA panel vote, AstraZeneca may look at narrow Lynparza nod in prostate cancer
A panel of external experts for the FDA voted 11 to 1 in support of a narrow approval for AstraZeneca and Merck’s Lynparza, used in tandem with Johnson & Johnson’s Zytiga and a corticosteroid, | A panel of external experts for the FDA voted 11 to 1 in support of a narrow approval for AstraZeneca…#fda #astrazeneca #merck #lynparza #johnsonjohnsons #zytiga #mcrpc #rickpazdur (Source: Reuters: Health)
Source: Reuters: Health - April 29, 2023 Category: Consumer Health News Source Type: news
FDA Staff Not Sold on Broad Olaparib Indication in Metastatic CRPC
(MedPage Today) -- Olaparib (Lynparza) plus abiraterone (Zytiga) as initial treatment for metastatic castration-resistant prostate cancer (CRPC) is only clearly effective in patients with BRCA mutations, FDA staff contended in a briefing document... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - April 27, 2023 Category: American Health Source Type: news
Janssen Marks First Approval Worldwide for AKEEGA ® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorization for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations
BEERSE, Belgium, 21 April 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted marketing authorisation for AKEEGA® (niraparib and abiraterone acetate [AA]), in the form of a dual action tablet (DAT), given with prednisone or prednisolone, for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.2Prostate cancer is the most common cancer in men in Europe, and the sixth-highest cause of cancer-related death worldwide.1...
Source: Johnson and Johnson - April 21, 2023 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson Reports Q1 2023 Results
New Brunswick, N.J. (April 18, 2023) – Johnson & Johnson (NYSE: JNJ) today announced results for first-quarter 2023. “Our first quarter results demonstrate strong performance across all three segments of our business and reflect the dedication of Johnson & Johnson colleagues around the world,” said Joaquin Duato, Chairman of the Board and Chief Executive Officer. “With this momentum, I look forward to the remainder of the year, one filled with exciting catalysts that will create both near- and long-term value for patients and all of our stakeholders.”OVERALL FINANCIAL RESULTSQ1($ in Millions, except EPS)2...
Source: Johnson and Johnson - April 18, 2023 Category: Pharmaceuticals Tags: Financial Source Type: news
Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate Dual-Action Tablet, Plus Prednisone, as a First-Line Targeted Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations
RARITAN, N.J., February 28, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of niraparib in combination with abiraterone acetate, in the form of a dual-action tablet (DAT), plus prednisone, for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). If approved, this will be the first DAT formulation available in the U.S. to patients with mCRPC with BRCA mutations, which are a type of homologous recombination repair (HRR) gene alt...
Source: Johnson and Johnson - March 1, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Prostate Cancer Subgroup May Benefit From Intensified Therapy Prostate Cancer Subgroup May Benefit From Intensified Therapy
In a subset of patients with high-risk prostate cancer, the combination of abiraterone acetate plus prednisone (AAP) and apalutamide may improve outcomes when added to salvage radiation therapy.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - February 27, 2023 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news
Janssen Receives Positive CHMP Opinion for AKEEGA ® (Niraparib and Abiraterone Acetate Dual Action Tablet) Plus Prednisone or Prednisolone for the Treatment of Adult Patients with BRCA1/2 Gene-Mutated Metastatic Castration Resistant Prostate Cancer
BEERSE, Belgium, 24 February 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation for AKEEGA® (niraparib and AA), in the form of a DAT, given with P or prednisolone, for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.[1]Niraparib is a highly selective poly adenosine diphosphate-ribose polymerase (PARP) inhibi...
Source: Johnson and Johnson - February 27, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Add-On Olaparib Continues to Show Benefit in First-Line Treatment of mCRPC
(MedPage Today) -- SAN FRANCISCO -- Adding the PARP inhibitor olaparib (Lynparza) to standard-of-care abiraterone (Zytiga) as initial treatment for metastatic castration-resistant prostate cancer (mCRPC) extended median progression-free survival... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - February 17, 2023 Category: Hematology Source Type: news
Janssen Presents Updated Data Demonstrating Improved Outcomes from the Use of Niraparib in Combination with Abiraterone Acetate Plus Prednisone as a First-Line Therapy in Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
SAN FRANCISCO, February 16, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced updated results from the Phase 3 MAGNITUDE study evaluating the investigational use of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) with or without specific homologous recombination repair (HRR) gene alterations, including BRCA mutations. Results will be featured today in a Rapid Abstract Session (Abstract #170) at the American Society of Clinica...
Source: Johnson and Johnson - February 16, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Janssen Data at ASCO GU Support Ambition to Transform Treatment of Prostate and Bladder Cancer Through Precision Medicine and Early Intervention
RARITAN, N.J., February 13, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced plans to present more than 20 abstracts featuring seven oncology therapies from its robust portfolio and pipeline at the annual American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, taking place in San Francisco on February 16-18. Building on more than a decade of leadership in the development of medicines for people diagnosed with GU cancers, Janssen will present data demonstrating its ambition to advance patient-centered treatment through precision medicine, real-world evidence a...
Source: Johnson and Johnson - February 13, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
