DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] DARZALEX FASPRO® is the first and only FDA-approved treatment for patients with this blood cell disorder that is associated with the production of an abnormal protein, which leads to the deterioration of vital organs, most notably the heart, kidneys and liver.[2],[3] This indication is approved under accelerated approval and is based on the hematologic complete response rate (hemCR) measure. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. DARZALEX FASPRO® is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.“Today’s milestone is an important step for patients diagnosed with this rare disease,” said Isabelle Lousada, Founder and CEO, Amyloidosis Research Consortium. “Sadly, most patients with AL amyloidosis are diagnosed more than one year after their initial symptoms p...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news

Related Links:

Mandatory mask-wearing in shops and transport reimposed in England;Anthony Fauci says new variant is probably already in the US;Australia scrambles to prevent outbreakJohnson ignored my plan to deal with new variants – ex-officialOmicron ’s worst impact will be in nations with low vaccination ratesWhat do we know about the new ‘worst ever’ Covid variant?See all our coronavirus coverageAustralian states and territories are braced for the spread of Omicron, with authorities conceding on Sunday that positive cases were inevitable.Both the NSW and Victorian governments have introduced 72-hour isolation ...
Source: Guardian Unlimited Science - Category: Science Authors: Tags: World news Coronavirus Science UK news Europe US news Source Type: news
ConclusionThe e-TEP-RS technique for large, complex, midline, ventral abdominal hernias can be used with excellent results and acceptable morbidity. This technique is technically challenging and should be mastered in relatively smaller ventral hernias to achieve good results before attempting it in larger, complex ones.
Source: Hernia - Category: Sports Medicine Source Type: research
This study evaluates the effectiveness of two postoperative analgesia modalities: epidural cat heter and surgeon-performed TAP-block following VHR performed with transversus abdominis release (TAR).MethodsA retrospective analysis was performed on data prospectively collected between 2012 and 2019. All patients undergoing open VHR with TAR performed by a single surgeon were identified. Parastomal hernia repairs and any patients receiving ultrasound-guided TAP blocks or paraspinal blocks were excluded. Primary outcome was length of stay (LOS) with secondary outcomes including pain scores, opioid requirements, and 30-day morb...
Source: Hernia - Category: Sports Medicine Source Type: research
Asya, 35, of south London, contracted Covid in December and was forced to deliver her son, Daniel, dangerously early at 27-and-a-half weeks.
Source: the Mail online | Health - Category: Consumer Health News Source Type: news
Source: BMJ Comments - Category: General Medicine Source Type: forums
Source: BMJ Comments - Category: General Medicine Source Type: forums
Source: BMJ Comments - Category: General Medicine Source Type: forums
A new coronavirus variant, first discovered in South Africa, has begun to spread around the globe. Vaccine producers say they're working to get ahead of the new strain.(Image credit: Denis Farrell/AP)
Source: NPR Health and Science - Category: Consumer Health News Authors: Source Type: news
“While individual doctors have obligations to both the individual and public health, their first concern is their patients. And these decisions have to acknowledge fears and respect the stance. Providers must balance reassurance with acknowledgment, care, data, and the intent to‘do no harm.’ It is undeniable that the COVID vaccination has saved countless livesRead more …Fear of vaccines grows with the need for medical ethics [PODCAST] originally appeared inKevinMD.com.
Source: Kevin, M.D. - Medical Weblog - Category: General Medicine Authors: Tags: Podcast COVID-19 coronavirus Infectious Disease Source Type: blogs
Here are the results of the poll. Is It Time To Give Up On The DOH/NETHA/ADHA Experiment Of Federal Government Involvement In Digital Health In Australia? Yes - It Has Been Long Enough 53% (43) No - They Need More Time To Get It Right 35% (28) I Have No Idea 12% (10) Total votes: 81 A small majority want to see the pain of the last decade stop while many more that usual are really confused. Quite a few wanted to be patient for a while longer - maybe worried about their jobs? Any insights on the poll are welcome, as a comment, as usual! A good number of votes with a clear outcome!  A very large 10 of 81 who answer...
Source: Australian Health Information Technology - Category: Information Technology Authors: Source Type: blogs
More News: Acetaminophen | Allergy & Immunology | Amyloidosis | Anaphylactic Shock | Arrhythmia | Back Pain | Biotechnology | Blood Transusion | Brain | Cancer & Oncology | Cardiology | Cardiovascular | Child Development | Children | Clinical Trials | Constipation | Corticosteroid Therapy | Cough | Databases & Libraries | Dexamethasone | Education | Food and Drug Administration (FDA) | Gastroenterology | Government | Hay Fever | Health Management | Heart | Heart Transplant | Hematology | Hypertension | Infectious Diseases | Insomnia | Insurance | Kidney Transplant | Kidney Transplantation | Laboratory Medicine | Learning | Legislation | Liver | Liver Transplant | Lortab | Medicaid | Medicare | Myeloma | Neurology | Neuroscience | Pain | Pain Management | Pharmaceuticals | Pneomococcal Vaccine | Pneumonia | Prednisone | Pregnancy | Pulmonary Hypertension | Rare Diseases | Respiratory Medicine | Revlimid | Science | Stem Cell Therapy | Stem Cells | Study | Thrombocytopenia | Toxicology | Transplant Surgery | Transplants | Universities & Medical Training | Urology & Nephrology | Vaccines | Velcade | Warnings | Women