First-line treatment of advanced lymphoma, ADC combination therapy is approved by the FDA today

Release date: 2018-03-22

Today, the US FDA announced the approval of Seattle Genetics' antibody conjugate Adcetris (brentuximab vedotin) to expand indications and use it in combination with chemotherapy to treat patients with stage III or IV classic Hodgkin's lymphoma.

Lymphoma is a cancer that develops in the lymphatic system and is mainly divided into Hodgkin's lymphoma and non-Hodgkin's lymphoma. Most Hodgkin's lymphoma patients are classified as "classic", and there are large abnormal lymphocytes in the lymph nodes - Reed-Sternberg cells. These patients often achieve long-term relief as long as the intervention is early enough.

Adcetris, which was approved today, is such a new drug that is expected to bring the gospel to lymphoma patients. As an antibody drug conjugate, it is composed of an antibody against a CD30 antigen, brentuximab, and an anti-mitotic drug, monomethyl astatin, E (MMAE). CD30 protein is a known molecular marker of classical Hodgkin's lymphoma, and MMAE is effective in inhibiting cell mitosis by inhibiting the polymerization of tubulin, which is separated by the proprietary protease of Seattle Genetics. The coupling is composed of coupling. Adcetris is stable in the blood circulation. When it is swallowed and internalized by CD30+ tumor cells, it releases MMAE, which leads to cell death.

In a clinical trial, the potential of Adcetris for the treatment of classic Hodgkin's lymphoma was validated—the researchers recruited 1,334 treated patients who had received an average of six 28-day cycles. Subsequently, they were divided into two groups, one receiving Adcetris and chemotherapy (AVD) and the other receiving chemotherapy (ABVD). Studies have shown that patients who receive combination therapy have a 23% lower risk of disease progression, death, or the need to start new treatment than patients who receive chemotherapy alone. In combination with G-CSF, a growth factor that promotes the growth of bone marrow leukocytes, the combination of Adcetris and chemotherapy is recommended by the FDA for first-line treatment of stage III or IV classic Hodgkin's lymphoma. In response to this indication, Adcetris has also been awarded the criteria for breakthrough therapy recognition and priority review.

It is worth mentioning that this is the fifth FDA approval of Adcetris. Previously, it was approved for the treatment of relapsed classic Hodgkin's lymphoma, a classic Hodgkin's lymphoma with high-risk recurrence or progression after stem cell transplantation, and systemic anaplastic large cell lymphocytes that have undergone other therapies but are ineffective. Tumor, as well as primary anaplastic large cell lymphoma of any other therapy.

"Today's approval represents an important advancement in advanced Hodgkin's lymphoma for more than 40 years," said Dr. Richard Pazdur, Director of the Center for Excellence in Cancer and Executive Director of the Department of Hematology and Oncology Products at the FDA Center: "This approval demonstrates the FDA. Commitment to bring new treatments to patients."

Reference materials:

[1] FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy

[2] FDA hands Seattle Genetics its 5th OK for Adcetris. But can they actually sell it for frontline Hodgkin lymphoma?

Source: WuXi PharmaTech

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