Johnson and Johnson Darzalex under-skin injections are approved by the European Union

The European Commission (EC) recently approved the JNJ heavy myeloma drug Darzalex (daratumumab, Daretoyu monoanti) subseskin (SC) preparation for the treatment of adult patients with multiple myeloma (MM), which covers all therapeutic adaptations currently approved by Darzalex venous (IV) preparations, including first-line treatment and recurring/difficult disease treatment.Darzalex SC is given at a fixed dose, injected under the skin, in just 3-5 minutes. Iv preparations, on the other end of the day, are administered intravenously and usually take several hours. The approval of SC preparations marks an important milestone that will help positively change the lives of MM patients who rely on Darzalex for treatment. Patients currently receiving IV preparations can choose to switch to SC preparation therapy.It is worth mentioning that Darzalex SC preparation is the only offsulate CD38 targeted antibody drug approved by regulatory authorities for the treatment of MM. In the United States, Darzalex SC preparations were approved in May this year under the brand name Darzalex Faspro (daratumumab and hyaluronidase-fihj, daretoyu monoanti-hyalurase), which was approved by the FDA to cover four options covering five therapeutic adaptations, including MM patients for new diagnoses, MM patients who do not qualify for transplantation, recurring or refractic MM patients.Clinical data show that Darzalex SC preparations have consistent efficacy and pharmacodynamics and similar safety compared to Darzalex IV preparations, significantly reducing treatment time (from hours to 3-5 minutes), and reducing the rate of systemic drug-related reactions (ARR) by two-thirds (13% vs 44%).This approval is based on the efficacy and safety data of Phase III clinical studies COLUMBA (MMY3012) and Phase II clinical studies PLEIADES (MMY2040).COLUMBA is a randomized open-label study that compared the non-shoddy effectiveness of Darzalex SC and Darzalex IV preparations for single-drug therapy in patients who had previously received at least 3 treatment options (including protease inhibitors (PI), immunomodulation agents (IMiD)) or MM patients who were difficult to treat both PI and IMiD.The results showed that Darzalex SC preparations and Darzalex IV preparations were effective (total remission rate: 41% vs 37%, ratio: 1.11, 95% CI: 0.89-1.37) and pharmacological dynamics (daratumumab valley concentration (Ctrough): 4 99mg/mL vs 463mg/mL, ratio value: 108%, 90% CI: 90%-122%) is non-shoddy, with shorter dosing time (5 minutes vs 3 hours or more), and a lower rate of systemic dosing-related reactions (ARR) (13% vs 34%).The ARR rate was 11% among 490 people who received Darzalex SC preparations as monotherapy or combined therapy. Darzalex IV preparations are similar to Darzalex SC preparations in other areas of safety profile.The Phase II PLEIADES study evaluated the efficacy and safety of Darzalex SC preparations in combined therapy. In newly diagnosed MM patients who did not qualify for transplantation, the efficacy of Darzalex SC preparations was confirmed with the combined drug treatment programme (D-VMP) of boratezomi, mafaran and pernisson. In addition, the efficacy of Darzalex SC preparations and the combined drug treatment programme (D-Rd) of Lynadamine and dexamisson was also confirmed in patients with relapsed or refractic MM who had previously received a treatment.In China, Darzalex was approved in October 2019 for single-drug treatment of adult patients with relapsed and refractic multiple myeloma, specifically in patients who have previously been treated with protease inhibitors and immunomodulants and who have progressed during the last treatment. As China's first approved CD38 monoclonal antibody targeted drug, this innovative program is expected to redefine the treatment of multiple myeloma in China.Darzalex is the world's first CD38-mediated, lysolytic antibody drug with broad-spectrum killer activity that targets cross-membrane extracellular enzyme CD38 molecules highly expressed on the surface of multiple myelomas and multiple solid tumor cells through a variety of immunological mediators The mechanism of action induces rapid death of tumor cells, including complementary dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxic action (ADCC), and antibody-dependent cell phagocytosis (ADCP), as well as apoptosis. In addition, Darzalex has been shown to be able to target immunosuppressive cells in the tumor micro-environment to exhibit immunomodulation activity.Darzalex was first approved for listing in November 2015 with sales of $2.998 billion in 2019. Currently, the drug has been approved by many countries around the world for first-, second-line, multi-line treatment of multiple myeloma, specifically approved adaptations vary from country to country, including: (1) November 2015, as a single-drug therapy, used in the past Adult patients receiving at least 3 therapies (including a protease inhibitor (PI) and an immunomodulant (IMiD)) or MM adult patients with dual incurable pIs and immunomodulants; (2) November 2016, in combination Nadamine and dexamysund, or combined boronitazome and dexamisong, for MM adult patients who have received at least one treatment in the past; MM adult patients who have received at least 2 treatments (including lanadamine and PI); (4) In May 2018, combined boroniczomi, melphalan and prednisone, For new adult patients who are not suitable for self-stem cell transplantation (ASCT), this approval makes Darzalex the first single anti-drug to be approved for new mm treatment. (5) In June 2019, a joint amine and dexamison were used for new adult patients who were not suitable for ASCT. (6) In September 2019, a joint boronzomi, salidamide, and dexamisson was approved for new ascension MM adult patients for ASCT, making Darzalex the first biologic agent approved for use in new ASCT-qualified patients.In February 2019, Darzalex's subdring drug program was also approved by the FDA. The program will allow healthcare professionals to choose as needed when treating MM patients, and divide Darzalex's first intravenous infusion from a single one-time infusion into two consecutive days of intravenous infusion. (Bio Valley)