Light chain amyloidosis (AL) is a progressive and rare disease whereby abnormal plasma cells found in the blood and urine over-produce light chain proteins. These proteins misfold into amyloid fibrils which are protein aggregates that are bound together in specific order.

According to a release issued by the FDA reported by the Cancer Network, standard approval has been granted for the prescription medication Darzalex Faspro to be used to treat patients who have been newly diagnosed with light chain amyloidosis (AL).

The target is CD38, a protein found in blood and urine, but due to its overproduction, it misfolds into amyloid fibrils.

About AL Treatment

Darzalex Faspro is a prescription medication for patients with newly diagnosed light chain amyloidosis (AL). It is administered via subcutaneous injection (under the skin) and is a combination of two drugs: daratumumab and hyaluronidase-flhj (Darzalex Faspro) plus bortezomib (Velcade), cyclophosphamide, and dexamethasone (VCd).

Darzalex Faspro works by targeting CD38, a protein used to treat light chain amyloidosis (AL).

Additional support was added by way of the phase 3 ANDROMEDA trial (NCT03201965) in which 388 patients were randomly assigned either daratumumab plus hyaluronidase-flja (Darzalex Faspro) and bortezomib (Velcade), cyclophosphamide, and dexamethasone (VCd).

The median follow-up was 61.4 months. Compared to treatment using VCD alone, there was less organ deterioration while there was an improvement in progression-free survival. However, median values in either cohort was not reached.

With a median follow-up of 61.4 months, the newly approved regimen improved major organ deterioration progression-free survival (MOD-PFS) vs VCd alone.

The recommended dose is 1800 mg of daratumumab and 30,000 units of hyaluronidase administered subcutaneously into the abdomen over 3 to 5 minutes.

The prescribing label has a Warning and Precaution for cardiac toxicity, as serious or fatal cardiac events occurred in those who received the combination.

A Warning and Precaution was also included for hypersensitivity and other administrative reactions, neutropenia, thrombocytopenia, embryo-fetal toxicity, and interference with cross-matching and red blood cellantibody screening.

Notably, the daratumumab and hyaluronidase is not recommended, or indicated, for the treatment of AL amyloidosis in patients with NYHA Class IIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled trials.

Previously, this regimen was granted accelerated approval in the same indication in 2021.2

Notice: This information is for reference purposes only. For medical advice please consult a professional.