UPDATE : Monday, September 7, 2020
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Regulator OKs Janssen's multiple myeloma treatment
  • By Lee Han-soo
  • Published 2020.07.06 15:48
  • Updated 2020.07.06 16:28
  • comments 0

Janssen Pharmaceutical said the Ministry of Food and Drug Safety has approved its Darzalex subcutaneous (SC) injection, a treatment for multiple myeloma, last Monday.

The Ministry of Food and Drug Safety approved Darzalex SC, Janssen's multiple myeloma treatment, on June 29. (Janssen)

"The SC injection can be administered in about three to five minutes, significantly lowing the time compared with the Darzalex intravenous (IV) injection, which took hours to administer," the company said. "Also, patients in clinical trials experienced nearly two-thirds fewer systemic infusion-related reactions (IRR) when treated with the SC method than the IV one."

The company expects that the SC formulation will sharply improve convenience for patients and clinicians, potentially enhancing healthcare efficiency in the treatment of multiple myeloma.

The ministry has approved the treatment for six indications in Korea, such as in combination with bortezomib, melphalan, and prednisone in newly diagnosed patients ineligible for autologous stem cell transplant (DVMP), and with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients eligible for autologous stem cell transplant (DVTd).

As a monotherapy, patients who have received at least three prior therapy lines, including a proteasome inhibitor (PI) and an immunomodulatory agent or double-refractory to a PI and an immunomodulatory agent, can receive the treatment.

The approval came after the company posted optimal results in a phase 3 COLUMBA study, demonstrating the efficacy and safety of the treatment.

The study evaluated the non-inferiority of a subcutaneous formulation of Darzalex in comparison to IV as a monotherapy in patients with multiple myeloma who had received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease was refractory to both a PI and an IMiD.

As a result, the treatment demonstrated a consistent overall response rate (ORR) and pharmacokinetics and a similar safety profile compared with the IV formulation in patients with relapsed or refractory multiple myeloma.

"Janssen is pleased that Darzalex SC has been approved as it will increase treatment options and increase treatment convenience for healthcare professionals and patients," Janssen Korea Managing Director Jenny Zheng said. "The treatment is expected to bring about positive changes in patients' lives since it can be administered in significantly less time than intravenous Darzalex."


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