DARZALEX (daratumumab) injection, for intravenous use. Initial U.S. Approval – 2015

DARZALEX (daratumumab) injection, for intravenous use. Initial U.S. Approval – 2015

INDICATIONS AND USAGE
DARZALEX is a CD38-directed cytolytic antibody indicated:
• in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy
• as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are doublerefractory to a PI and an immunomodulatory agent.
DOSAGE FORMS & STRENGTHS
Injection:
• 100 mg/5 mL solution in a single-dose vial
• 400 mg/20 mL solution in a single-dose vial
Manufactured By: Janssen Biotech, Inc.
Prescribing Information URL: Click Here

Access to DARZALEX (daratumumab) injection: Anticancer drugs available upon request. To get best price please share your mobile number to receive quotes from Medvitaz Pharma Solutions.

In November 2015, the U.S. Food and Drug Administration (FDA) approved daratumumab for treatment of multiple myeloma in people who had received at least three prior therapies. In May 2016 daratumumab was also conditionally approved by the European Medicines Agency for treatment of multiple myeloma.
In November 2016, the FDA approved daratumumab in combination with lenalidomide or bortezomib and dexamethasone for the treatment of people with multiple myeloma who have received at least one prior therapy.
In May 2018, the FDA expanded the approval of daratumumab for use in combination with bortezomib, melphalan and prednisone to include the treatment of people with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The European Commission granted a marketing authorisation on 20 May 2016.
In the European Union it is indicated as monotherapy for the treatment of adults with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.

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 The profound knowledge of more than 20 years in sales and marketing sector, he has been working dedicatedly and contributing to pharmaceuticals industry. He handles all operations over the country.

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