FDA Approves Roche’s Antibody Drug Conjugate Cancer Drug PolivyBy
The US Food and Drug Administration (FDA) has approved Roche’s Polivy (polatuzumab vedotin-piiq) to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies.
Polivy was approved for use in combination with the chemotherapy, bendamustine, plus Roche’s/Biogen’s Rituxan (rituximab) (BR). Polivy is an antibody-drug conjugate (ADC) that specifically targets CD79b, a protein expressed in a majority of B-cells. DLBCL is the most common type of non-Hodgkin’s lymphoma.
Polivy binds to a specific protein (CD79b) found in B white blood cells, then releases the chemotherapy drug into those cells, according to information from the FDA. More than 18,000 people are diagnosed with DLBCL each year in the United States. This type of cancer grows quickly in lymph nodes and can affect bone marrow, spleen, liver or other organs.
The FDA granted Polivy, in combination with BR, accelerated approval, based on complete response rates observed in a randomized, controlled clinical trial and also granted breakthrough therapy, priority review, and orphan drug designations. The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Polivy is being developed by Roche using Seattle Genetics’ ADC technology and is currently being investigated for the treatment of several types of non-Hodgkin’s lymphoma.