Subcutaneous Formulation of Daratumumab Approved

1. Brand Name : Darzalex Faspro

2. Generic Name : Daratumumab and Hyaluronidase-fihj

3. Date of approval : 1 May 2020

4. Company : The Janssen Pharmaceutical Companies of Johnson & Johnson

5. Indication : Multiple Myeloma

6. Approval : Subcutaneous formulation of daratumumab

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.

Daratumumab and hyaluronidase-fihj is approved for the following indications that intravenous daratumumab had previously received:

1. in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant,

2. in combination with lenalidomide and dexamethasone 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,

3. in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy,

4. as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

Detailed report will be updated soon ......

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