First anti-CD38 monoclonal antibody is registered in the Russian Federation

| By | Cancer Drugs, Drug Registration, Janssen

Janssen, a pharmaceutical division of Johnson & Johnson, announced the market launch of Darzalex (daratumumab), a drug that received the certificate of state registration in the Russian Federation on July 7, 2017 for monotherapy in patients with relapsed or refractory multiple myeloma previously treated with proteasome inhibitors and immunomodulatory medications.

Darzalex is the first fully human monoclonal antibody that targets CD38, a surface protein expressed to a significant extent in all myeloma cells, regardless of disease stage. Its innovative mechanism of action allows rapid destruction of tumor cells using several mechanisms.

“Our efforts are focused on developing the innovative medicinal products for people with intractable cancers such as multiple myeloma. We are very pleased that Darzalex is now available to patients in Russia,” said Katerina Pogodina, the Managing Director of Janssen Russia and CIS. “The development and market launch of Darzalex, the first fully human monoclonal antibody targeting CD38, reflects our commitment to address the unresolved problems in health care. We will continue to study the properties of this drug both in monotherapy and combination therapy in patients at all key stages of the disease in order to get full information about its clinical benefits.”

GMP news
Pharmaceutical industry News and events. Technology transfer and contract manufacturing of medicines.