Articles tagged with: FDA Approval
Press Releases»
Silver Spring, MD (Press Release) – Today the U.S. Food and Drug Administration granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma.
Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, produce an abnormal protein and push out other healthy blood cells from the bone marrow. The disease may result …
News»
The U.S. Food and Drug Administration (FDA) on Monday approved Farydak (panobinostat) for the treatment of multiple myeloma (see related Beacon news).
Since the FDA announced its decision, multiple myeloma patients, caregivers, and health care professionals have been asking a number of important questions about Farydak. This article compiles many of those questions and provides answers to them.
The information in this article is based primarily on the official, FDA-approved prescribing information for Farydak. In addition, The Beacon has received feedback in regard to several questions …
News»
The U.S. Food and Drug Administration (FDA) has approved panobinostat, which will be marketed under the brand name Farydak, for the treatment of relapsed and refractory multiple myeloma.
Specifically, Farydak has been approved for use in combination with Velcade (bortezomib) and dexamethasone (Decadron) in patients with multiple myeloma who have received at least two prior standard therapies.
The two prior therapies must include Velcade and at least one treatment from the immunomodulatory class of drugs, which includes Revlimid (lenalidomide), thalidomide, and Pomalyst (pomalidomide, Imnovid). …
Press Releases»
Silver Spring, MD (Press Release) - The U.S. Food and Drug Administration today approved Farydak (panobinostat) for the treatment of patients with multiple myeloma.
Multiple myeloma is a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow. According to the National Cancer Institute, approximately 21,700 Americans are diagnosed with multiple myeloma and 10,710 die from the disease annually.
Primarily affecting older adults, multiple myeloma causes plasma cells to rapidly multiply and crowd out other healthy blood cells from the bone marrow. When …
NewsFlash »
Siltuximab, a drug that has been tested as a potential new treatment for multiple myeloma, was approved last week by the U.S. Food and Drug Administration (FDA).
Its approval, however, was as a new treatment for a form of Castleman's disease, a rare disorder similar to lymphoma.
Siltuximab will be marketed in the United States by the Janssen Biotech division of Johnson & Johnson (NYSE:JNJ). The drug's brand name will be Sylvant.
Johnson & Johnson also has submitted an application with the European Medicines Agency to market siltuximab in Europe as a treatment for Castleman's disease. A decision on the European application, however, has not yet been announced.
Siltuximab has been investigated in several clinical trials as a potential treatment for myeloma. Initial results for one trial were presented at the American Society of Hematology annual meeting in 2011. The results showed that siltuximab was active against multiple myeloma, but patients treated with the drug also experienced significant side effects (see related Beacon news article). Updated results from that trial were published last year, and another study was published recently examining the impact of siltuximab on the heart function of myeloma patients treated with the drug.
Only one clinical trial of siltuximab in myeloma patients is still ongoing and recruiting patients. The international multicenter trial is testing siltuximab as a potential treatment for high-risk smoldering myeloma.
It's not known whether the location of Janssen Biotech's headquarters – which is in Pennsylvania – influenced the company's decision to select Sylvant as the brand name for siltuximab.
For more information about siltuximab's FDA approval, see the related press releases from the FDA and Johnson & Johnson.
News»
On Friday, the U.S. Food and Drug Administration (FDA) approved Pomalyst (pomalidomide) for the treatment of multiple myeloma patients who have received at least two prior therapies (see related Beacon news).
In this article, The Beacon addresses important questions multiple myeloma patients have been asking about the FDA decision. The article is organized similarly to one the Beacon published about Kyprolis (carfilzomib) after it was approved by the FDA last summer.
What exactly did the FDA …
News»
The United States Food and Drug Administration (FDA) has approved pomalidomide, which will be marketed under the brand name Pomalyst, for the treatment of relapsed and refractory multiple myeloma.
Specifically, Pomalyst has been approved for use in patients with multiple myeloma who have received at least two prior therapies including Revlimid (lenalidomide) and Velcade (bortezomib) and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Celgene (NASDAQ:CELG), the company that will market Pomalyst, has told The Beacon that the drug will be …