Roche (OTCQX:RHHBY) (OTCQX:RHHBFA panel of the U.S. Food and Drug Administration (FDA) said it voted in favor of approval of a combination therapy consisting of the drug Polivy to treat certain types of blood cancers.
of The FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) and cyclophosphamide, doxorubicin, and prednisone (R-CHP) in a 11:2 Diffuse large B-cell lymphoma (DLBCL).
The Swiss pharmaceutical giant has submitted a supplemental biologics license application (sBLA) to the FDA. accepted A review is required in August 2022.
U.S. drug regulatory agencies are expected to make decisions on the application by April 2nd.
“Today’s panel endorses this potential combination of Polivy as a first-line treatment option because 4 in 10 patients with diffuse large B-cell lymphoma relapse or do not respond to initial therapy. Decisions Matter.Officer and Head of Global Product Development.
sBLA is backed by data from a Phase 3 trial called POLARIX.
Roche I got it Over 60 countries including UK, EU, Japan, Canada and China approved This Polivy combination treats adult patients with untreated DLBCL, a cancer that occurs when the body produces abnormal B lymphocytes, a type of white blood cell.
The combination of Polivy, bendamustine and MabThera/Rituxan had received accelerated FDA approval to treat adults with relapsed or refractory DLBCL after one or more prior treatments, according to the company. .
#Roche #receives #FDA #panel #approval #Polivy #initial #treatment #large #Bcell #lymphoma