One month in advance! New lymphoma drug approved today

Source: Wuxi apptec 2017-11-10 today, Seattle genetics announced that FDA approved its new drug adcetris (brentuximab vedotin) to treat adult patients with primary cutaneous anaplastic large cell lymphoma (PCALCL) and mycosis fungoides (MF) expressing CD30, who have received systemic treatment Lymphoma is a kind of cancer originated from the lymphatic system, including Hodgkin's lymphoma and non Hodgkin's lymphoma Cutaneous lymphoma is a kind of non-Hodgkin's lymphoma mainly involving the skin According to the definition of skin lymphoma Foundation (CLF), cutaneous T-cell lymphoma (CTCL) is the most common type of skin lymphoma, which usually presents as red, squamous or thickened skin patches, similar to eczema or chronic dermatitis The most common subtypes of CTCL include PCALCL and MF, accounting for more than 75% of the disease type At present, the objective remission rate of systemic treatment approved for this disease is 30% - 45%, and the complete remission rate is very low These patient groups are in urgent need of new treatment methods to increase the possibility of disease relief Adcetris is an antibody drug conjugate (ADC) that connects anti-CD30 monoclonal antibody and microtubule destructor MMAE through protease cleavage type bond The researchers cleverly designed a linker system that releases MMAE when the ADC is present in a stable form in the blood circulation but internalized into CD30 positive tumor cells It is expected to bring new treatment options for patients with CTCL This adcetris approval is based on data from a phase 3 clinical trial alcanza and two phase 2 clinical trials initiated by the investigator Alcanza, a phase 3 study, was designed to compare the efficacy of adcetris monotherapy (once every three weeks) with methotrexate or besarotene, a standard treatment chosen by doctors The trial reached the primary end point, with a statistically significant improvement in the objective response rate (orr4) of at least 4 months in the adcetris group compared to the control group assessed by an independent evaluation agency The orr4 of adcetris group was 56.3% (95% CI: 44.1, 68.4), while that of control group was 12.5% (95% CI: 4.4, 20.6) (P < 0.001) The most common adverse reactions (≥ 20%) included anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue and neutropenia "Cutaneous T-cell lymphoma is a blood cancer of the skin There is no known treatment and no new treatment option This is a depressing disease, and there is an urgent need for more effective and durable treatment to help control this debilitating and painful disease " "As a representative of patients with skin lymphoma and this group, we welcome FDA approval of adcetris as the most common skin T We look forward to sharing this important milestone with patients and doctors about new treatment options for patients with cell lymphoma subtypes who need systemic therapy " "Our phase 3 alcanza clinical trial evaluated the efficacy of adcetris in the treatment of primary cutaneous anaplastic large cell lymphoma and mycosis fungoides (the most common type of cutaneous T-cell lymphoma), which showed superior efficacy and long-lasting response in long-term disease management compared with methotrexate and bersalodin, the standard treatment option," Seattle genetics Dr clay Siegal, President and CEO, said: "these data, as well as data from clinical trials initiated by researchers, have led FDA to approve adcetris for the treatment of patients with PCALCL or MF expressing CD30, which represent the most common subtype of CTCL FDA approval of the drug one month ahead of PDUFA's date represents an important milestone for the lymphoma population Our goal is to use adcetris as the basis for the treatment of CD30 expressing lymphoma, and this approval represents the fourth indication approved by FDA " We congratulate adcetris on its fourth approved indication and look forward to it bringing disease relief to patients in need as soon as possible.