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Monday, June 10, 2019

FDA grants accelerated review status for Roche’s Polivy

Roche’s (OTCQX:RHHBY +0.2%) Genentech unit announces accelerated review status in the U.S. for antibody-drug conjugate Polivy (polatuzumab vedotin-piiq), combined with chemo agent bendamustine [Teva’s (TEVA+2.2%) Bendeka] and Rituxan (rituximab), for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies.
Polivy targets a protein expressed in most B cells called CD79b. Polatuzumab binds to CD79b thereby delivering the cytotoxic agent directly to the B cell.
The company’s marketing application is currently under FDA review with an action date of August 19.

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