FDA Approves J&J's Darzalex Faspro for Rare Light Chain Amyloidosis
The U.S. Food and Drug Administration (FDA) approved Janssen Pharmaceuticals’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis.
Darzalex Faspro is a combination of daratumumab and hyaluronidase-fihj, a subcutaneous formulation of daratumumab. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). It is the first and only FDA-approved therapy for patients with this indication. It was developed with Genmab. The two companies entered a global development, manufacture and commercialization deal in August 2021. Darzalex Faspro is the only CD38-directed antibody that has been approved for subcutaneous injection for multiple myeloma, and now AL amyloidosis. It is co-formulated with recombinant hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.
AL amyloidosis is a blood disorder associated with an abnormal protein that causes deterioration of vital organs, especially the heart, kidneys and liver. The drug is not indicated or recommended for patients with light chain amyloidosis who have NYHA Class IIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.
AL amyloidosis affects about 4,500 people in the U.S. each year. About a third of patients see five or more doctors before finally receiving an accurate diagnosis, and 72% are diagnosed more than a year after their first symptoms. The prognosis is often poor because of the delayed diagnosis, largely because the symptoms are similar to many other more common conditions. About 30% of patients with AL amyloidosis die in the first year after diagnosis.
哪位高手来评价一下？
FDA Approves J&J's Darzalex Faspro for Rare Light Chain Amyloidosis
The U.S. Food and Drug Administration (FDA) approved Janssen Pharmaceuticals’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly
diagnosed light chain amyloidosis.
Darzalex Faspro is a combination of daratumumab and hyaluronidase-fihj, a
subcutaneous formulation of daratumumab. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). It is the first and only FDA-approved therapy for patients with this indication. It was
developed with Genmab. The two companies entered a global development,
manufacture and commercialization deal in August 2021. Darzalex Faspro is
the only CD38-directed antibody that has been approved for subcutaneous
injection for multiple myeloma, and now AL amyloidosis. It is co-formulated with recombinant hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug
delivery technology.
AL amyloidosis is a blood disorder associated with an abnormal protein that causes deterioration of vital organs, especially the heart, kidneys and
liver. The drug is not indicated or recommended for patients with light
chain amyloidosis who have NYHA Class IIB or Class IV cardiac disease or
Mayo Stage IIIB outside of controlled clinical trials.
AL amyloidosis affects about 4,500 people in the U.S. each year. About a
third of patients see five or more doctors before finally receiving an
accurate diagnosis, and 72% are diagnosed more than a year after their first symptoms. The prognosis is often poor because of the delayed diagnosis,
largely because the symptoms are similar to many other more common
conditions. About 30% of patients with AL amyloidosis die in the first year after diagnosis.