Genentech Receives FDA Approval for Polivy

Lymphoma

Clinical Oncology reports that the FDA has granted accelerated approval to polatuzumab vedotin-piiq (Polivy) in combination with bendamustine and a rituximab product (BR) to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies.

What is Polivy?

It is a novel antibody-drug conjugate, and DLBCL is the most common type of non-Hodgkin lymphoma. The drug binds to a protein (CD79b) found only on B cells, and then releases the chemotherapy drug into those cells. It essentially is providing an alternative treatment option for patients when multiple treatment options have not worked.

Side Effects

The most common side effects reported include neutropenia, thrombocytopenia and anemia; peripheral neuropathy; fatigue; diarrhea, fever; decreased appetite; and pneumonia.

Recommendations

Health care professionals are advised to monitor patients closely for infusion-related reactions, low blood counts, and fatal and/or serious infections.  They should also monitor for tumor lysis syndrome, hepatotoxicity and progressive multifocal leukoencephalopathy.  Women who are of reproductive age have specific recommendations as do women who are pregnant or breastfeeding who shouldn’t take the drug.

Breakthrough Therapy

The FDA granted the Genentech (Roche) application as a breakthrough therapy, priority review and orphan drug designation streamlining the whole process.

Responses

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