The US FDA approves the first chemoimmunotherapy regimen Polivy with BR for patients with relapsed or refractory diffuse large B-cell lymphoma.
M2 PHARMA-June 11, 2019-The US FDA approves the first chemoimmunotherapy regimen Polivy with BR for patients with relapsed or refractory diffuse large B-cell lymphoma
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Public health agency the US Food and Drug Administration reported on Monday that it has awarded accelerated approval to Polivy (polatuzumab vedotin-piiq), chemotherapy bendamustine and the rituximab combination for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) through its breakthrough and priority review designations.
Biotechnology company Genentech was granted the approval for Polivy, to be used in combination with the chemotherapy bendamustine and a rituximab product (a combination known as BR) to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies.
According to the agency, Polivy is a novel antibody-drug conjugate that is attached to a chemotherapy drug. Polivy binds to a specific protein (called CD79b) found only on B cells (a type of white blood cell), then releases the chemotherapy drug into those cells.
Genentech reportedly randomised 80 patients with relapsed or refractory DLBCL with Polivy with BR or BR alone. At the end of treatment study, the complete response rate was 40% with Polivy plus BR compared to 18% with BR alone.
DLBCL is the most common type of non-Hodgkin lymphoma and although it can be cured, about 30 to 40% of patients suffer relapse. This type of cancer grows quickly in the lymph nodes and may affect the bone marrow, spleen, liver or other organs.
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|Date:||Jun 11, 2019|
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