Darzalex Faspro FDA Approval History

Last updated by Judith Stewart, BPharm on July 31, 2024.

FDA Approved: Yes (First approved May 1, 2020)
Brand name: Darzalex Faspro
Generic name: daratumumab and hyaluronidase-fihj
Dosage form: Injection
Company: Johnson & Johnson Innovative Medicine
Treatment for: Multiple Myeloma; Light Chain (AL) Amyloidosis

Darzalex Faspro (daratumumab and hyaluronidase-fihj) is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of multiple myeloma and light chain (AL) amyloidosis.

• Darzalex Faspro is indicated for the treatment of adult patients with:
  - multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone (Darzalex Faspro-VRd) for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant.
  - multiple myeloma in combination with bortezomib, melphalan and prednisone (Darzalex Faspro-VMP) in newly diagnosed patients who are ineligible for autologous stem cell transplant.
  - multiple myeloma in combination with lenalidomide and dexamethasone (Darzalex Faspro-Rd) in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
  - multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone (Darzalex Faspro-VTd) in newly diagnosed patients who are eligible for autologous stem cell transplant.
  - multiple myeloma in combination with bortezomib and dexamethasone (Darzalex Faspro-Vd) in patients who have received at least one prior therapy.
  - multiple myeloma in combination with pomalidomide and dexamethasone (Darzalex Faspro-Pd) in patients who have received at least one prior line of therapy. including lenalidomide and a proteasome inhibitor.
  - multiple myeloma in combination with carfilzomib and dexamethasone (Darzalex Faspro-Kd) in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
  - multiple myeloma as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
  - light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone (Darzalex Faspro-VCd) in newly diagnosed patients.
  This indication is approved under 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).
• Limitations of Use: 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.
• Darzalex Faspro is a subcutaneous formulation of Darzalex, an established treatment for multiple myeloma that is given by intravenous infusion over a period of hours. Darzalex Faspro is administered by subcutaneous injection over a much shorter period of approximately three to five minutes.
• Warnings and precautions associated with Darzalex Faspro include hypersensitivity and other administration reactions, cardiac toxicity in patients with light chain (AL) amyloidosis, neutropenia, thrombocytopenia, embryo-fetal toxicity, and interference with cross-matching and red blood cell antibody screening.
• The most common adverse reactions:
  - in patients with multiple myeloma who received Darzalex Faspro-VRd include peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia, and rash.
  - in patients with multiple myeloma who received Darzalex Faspro monotherapy is upper respiratory tract infection.
  - in patients with multiple myeloma who received Darzalex Faspro-VMP include upper respiratory tract infection, constipation, nausea, fatigue, pyrexia, peripheral sensory neuropathy, diarrhea, cough, insomnia, vomiting, and back pain.
  - in patients with multiple myeloma who received Darzalex Faspro-Rd are fatigue, diarrhea, upper respiratory tract infection, muscle spasms, constipation, pyrexia, pneumonia, and dyspnea.
  - in patients with multiple myeloma who received Darzalex Faspro-Pd are fatigue, pneumonia, upper respiratory tract infection, and diarrhea.
  - in patients with multiple myeloma who received Darzalex Faspro-Kd are upper respiratory tract infection, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and peripheral edema.
  - in patients with light chain (AL) amyloidosis are upper respiratory tract infection, diarrhea, peripheral edema, constipation, fatigue, peripheral sensory neuropathy, nausea, insomnia, dyspnea, and cough.
  The most common hematology laboratory abnormalities with Darzalex Faspro include decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.

Development timeline for Darzalex Faspro

Further information

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