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
Patients Needed for New Mesothelioma Clinical Trial
A new investigational drug for mesothelioma can now begin human trials after it was granted fast-track designation by the U.S. Food and Drug Administration last week. The novel treatment, SnyKIR-110, is a T-cell therapy designed to treat patients with mesothelioma, cholangiocarcinoma (bile duct cancer) and ovarian cancer.
“We are thrilled to receive fast-track designation from the FDA,” said Dr. Bryan Kim, co-founder and CEO of Verismo Therapeutics. “This designation is an important milestone in our efforts to bring this potentially life-saving drug to patients who are in need of new treatment option...
Source: Asbestos and Mesothelioma News - April 19, 2023 Category: Environmental Health Authors: Fran Mannino Tags: Clinical Trials/Research/Emerging Treatments Mesothelioma 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
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
Strategy to Reduce Peritoneal Metastases in Gastric Cancer Strategy to Reduce Peritoneal Metastases in Gastric Cancer
New data suggest hyperthermic intraperitoneal chemotherapy may help reduce peritoneal metastases after gastric cancer surgery. The study was published as a preprint and has not yet been peer reviewed.First Look (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - February 17, 2023 Category: Cancer & Oncology Tags: Hematology-Oncology News 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
Study Supports Routine Omentectomy in Absence of Metastasis During CRS-HIPEC
(MedPage Today) -- Almost one-third of patients undergoing omentectomy for peritoneal metastases had occult omental metastases, supporting routine omentectomy prior to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - January 11, 2023 Category: Hematology Source Type: news
FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FR α positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 14, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Janssen to Highlight Science, Innovation and Advances in Robust Oncology Portfolio and Pipeline Through More Than 60 Data Presentations at ASCO and EHA
RARITAN, N.J., May 31, 2022 — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that new research and data from its robust oncology portfolio and pipeline of investigational therapies will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 3-7 in Chicago, and the European Hematology Association (EHA) 2022 Congress taking place in Vienna, Austria, June 9-12. More than 60 presentations from company-sponsored studies across the two congresses, including 14 oral presentations, will feature new data and updates for both approved and investigation...
Source: Johnson and Johnson - May 31, 2022 Category: Pharmaceuticals Source Type: news
PET/MRI provides new insights into knee osteoarthritis
PET/MRI has identified which compartments of the knee may be the best target...Read more on AuntMinnie.comRelated Reading:
PET/MRI superior to MRI for diagnosing prostate cancer
ECR: Hypmed project develops affordable PET/MRI for breast scans
PET/MRI appears safe for pregnant women
PET/MRI can improve diagnosis of peritoneal cancer
PET/MRI proves TNF blockers effective for ankylosing spondylitis (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - May 19, 2022 Category: Radiology Source Type: news
New Clue to Risk of Peritoneal Cancer After Prophylactic Salpingo-Oophorectomy
(MedPage Today) -- The presence of serous tubal intraepithelial carcinoma (STIC) at the time of risk-reducing salpingo-oophorectomy (RRSO) significantly increased the risk of peritoneal carcinomatosis (PC) in BRCA1/2 mutation carriers, a large... (Source: MedPage Today OB/GYN)
Source: MedPage Today OB/GYN - April 5, 2022 Category: OBGYN Source Type: news
PET/MRI superior to MRI for diagnosing prostate cancer
PET/MRI imaging with an experimental prostate-specific membrane antigen (PSMA...Read more on AuntMinnie.comRelated Reading:
PET improves prostate cancer survival predictions
FDA approves Lu-177 PSMA-617 for prostate cancer treatment
PET/MRI appears safe for pregnant women
PET/MRI can improve diagnosis of peritoneal cancer
How can the clinical potential of PET/MRI be unlocked? (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - March 31, 2022 Category: Radiology Source Type: news
ECR: Hypmed project develops affordable PET/MRI for breast scans
A European research project called Hypmed is developing a more affordable versio...Read more on AuntMinnie.comRelated Reading:
ECR: Breast MRI tops contrast mammo for risk-based screening
ECR: How can imaging screen for COVID damage to kidneys?
ECR: What will it be like to be a radiologist in 2030?
PET/MRI appears safe for pregnant women
PET/MRI can improve diagnosis of peritoneal cancer (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - March 4, 2022 Category: Radiology Source Type: news
ECR: Hypmed project develops affordable PET/MRI for breast imaging
A European research project called Hypmed is developing a more affordable versio...Read more on AuntMinnie.comRelated Reading:
ECR: Breast MRI tops contrast mammo for risk-based screening
ECR: How can imaging screen for COVID damage to kidneys?
ECR: What will it be like to be a radiologist in 2030?
PET/MRI appears safe for pregnant women
PET/MRI can improve diagnosis of peritoneal cancer (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - March 4, 2022 Category: Radiology Source Type: news
Janssen Presents New Data Demonstrating the Combination of Niraparib and Abiraterone Acetate Plus Prednisone Significantly Improved Radiographic Progression-Free Survival as a First-Line Therapy in Patients with HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
SAN FRANCISCO, Feb. 14, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced initial results from the Phase 3 MAGNITUDE study evaluating the investigational use of niraparib, a selective poly-ADP ribose polymerase (PARP) inhibitor, in combination with abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) with or without specific homologous recombination repair (HRR) gene alterations. At the final analysis for radiographic progression-free survival (rPFS), the treatment combination of niraparib and abiraterone acetate plus prednisone de...
Source: Johnson and Johnson - February 14, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
