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Mosunetuzumab ELISA Kit

Product Specifications

Background

Polatuzumab vedotin is an active ingredient of Polivy, a drug product for the treatment of previously treated adult patients with diffuse large B-cell lymphoma (DLBCL) in combination with bendamustine and rituximab. Polatuzumab vedotin is an antibody-drug conjugate composed of a humanized monoclonal antibody (mAb) targeting B-cell antigen receptor complex-associated protein beta chain (CD79b) and a microtubule-disrupting toxin, monomethyl auristatin E (MMAE) . This drug was developed by Genentech/Roche using a proprietary technology developed by Seattle Genetics. In 2018, orphan designation was granted for polatuzumab vedotin for the treatment of diffuse large B-cell lymphoma by the European Commission to Roche Registration Limited. Based on the effective therapeutic effect of polatuzumab vedotin on DLBCL, the U.S. Food and Drug Administration (FDA) granted accelerated approval to polatuzumab vedotin, in combination with bendamustine plus rituximab on 10 June 2019. Subsequently, the European Medicines Health and Therapeutic Goods Administration of Australian Drug Regulatory Administration also approved Polivy's sales authorization from Genentech. Besides DLBCL, polatuzumab vedotin also has been investigated in the treatment of non-hodgkins lymphoma, chronic lymphocytic leukemia, follicular lymphoma. Some of the trials were complicated, and there are six clinical trials still undergoing now. For example, there is a phase Ib/II study investigating the safety, tolerability, pharmacokinetics, and efficacy of mosunetuzumab (BTCT4465A) in combination with chop or chp-polatuzumab vedotin in participants with b-cell non-hodgkin lymphoma. Furthermore, a study to evaluate the safety and efficacy of polatuzumab vedotin in combination with rituximab, gemcitabine and oxaliplatin compared to rituximab, gemcitabine and oxaliplatin alone in participants with relapsed or refractory diffuse large B-cell lymphoma is recruiting. The recent events of polatuzumab vedotin is that Chugai Pharmaceutical, another developer, adverse events data from a phase ii (jo40762/p-drive) trial diffuse large B-cell lymphoma and announces intention to submit NDA to Ministry of Health, Labour and Welfare for diffuse large B-cell lymphoma in Japan on February 2020. At the same period, a phase-II clinical trials in diffuse large B cell lymphoma is undergoing in United Kingdom (IV) .

Product Name Alternative

BTCT4465A, RG-7828, RO7030816, CAS: 1905409-39-3

Detection Method

Colorimetric

Assay Type

Quantitative

Sample Type

Plasma, Serum

Detection Range

0.31-5 μg/mL

Recovery

80-120 %

Sensitivity

0.156 μg/ml

Shipping Conditions

2-8 °C

Storage Conditions

The stability of ELISA kit is determined by the loss rate of activity. The loss rate of this kit is less than 10% prior to the expiration date under appropriate storage condition.
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