On January 15, 2021, the Food and Drug Administration granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech Inc.) in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain (AL) amyloidosis.
On january 15 2021 the food and drug administration granted accelerated approval to daratumumab plus hyaluronidase darzalex fasbro janssen biotech incorporated in combination with bortazomib cyclophosphamide and dexamethasone for newly diagnosed light chain al amyloidosis efficacy was evaluated in andromeda nct 03201965 an open label randomized active controlled
Trial in 388 patients with newly diagnosed al amyloidosis with measurable disease and at least one affected organ according to consensus criteria patients were randomized to receive bortizomibe cyclophosphamide and dexamethasone vcd arm or with darzalix fastpro dvcd arm the hematologic complete response mcr rate based on established consensus response criteria
As evaluated by an independent review committee was 42.1 percent for the dvcd arm and 13.5 percent for the vcd arm odds ratio equals 4.8 95 ci 2.9 8.1 p 0.0001 the prescribing information includes a warnings and precautions that serious or fatal cardiac adverse reactions occurred in patients with light chain al amyloidosis who received darzolic’s fasbro in
Combination with bordezomb cyclophosphamide and dexamethasone darzalex faspro is not indicated and is not recommended for the treatment of patients with light chain al amyloidosis who have nyha class iib or class iv cardiac disease or mayo stage iiib outside of controlled clinical trials the most common adverse reactions greater than or equal to 20 percent in
Patients with light chain al amyloidosis who received the dvcd regimen are upper respiratory tract infection diarrhea peripheral edema constipation peripheral sensory neuropathy fatigue nausea insomnia dyspnea and cough the recommended darzolic fasbro dose is 1800 milligrams deratumumab and 30 000 units hyaluronidase administered subcutaneously into the abdomen
Over approximately three to five minutes according to recommended schedule in combination with vcd viewful prescribing information for darzalex fassbro this review was conducted under project orbis an initiative of the fda oncology center of excellence project orbis provides a framework for concurrent submission and review of oncology drugs among international
Partners for this review fda collaborated with the australian therapeutic goods administration tga the brazilian health regulatory agency anvisa health canada and switzerland swiss medic and visa approved this application on november 30 2020 the application reviews are ongoing at the other regulatory agencies this review used the real-time oncology review rtor
Pilot program which streamlined data submission prior to the filing of the entire clinical application and the assessment aid a voluntary submission from the applicant to facilitate the fda’s assessment the fda approved this application seven weeks ahead of the fda goal date this application was granted accelerated approval based on response rate continued approval
For this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial s healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to fda’s medwatch reporting system or by calling one 800 fda 1088
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FDA grants accelerated approval to Darzalex Faspro for newly diagnosed light chain amyloidosis By My Cancer Wiki
