Genentech Medicine Received Accelerated FDA Approval as a New Treatment Option for People with Previously Treated Aggressive Lymphoma
June 10th, 2019
On June 10, 2019, the FDA granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies. Accelerated approval was granted for this indication based on complete response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The FDA's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition.
News in brief
- This accelerated approval is based on the Phase Ib/II GO29365 study, which showed Polivy in combination with BR resulted in higher complete response rates for people with R/R DLBCL compared to BR alone.
- Polivy is a first-in-class anti-CD79b antibody-drug conjugate. The CD79b protein is expressed in the majority of B-cells, an immune cell impacted in some types of non-Hodgkin’s lymphoma (NHL), making it a promising target for the development of new therapies.
- DLBCL is the most common form of NHL, accounting for about one in three cases. In the U.S., it is estimated that nearly 25,000 new cases of DLBCL will be diagnosed in 2019.
Important Safety Information
Possible serious side effects
Everyone reacts differently to POLIVY therapy, so it’s important to know what the side effects are. Some people who have been treated with POLIVY have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects.
- Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern
- Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion
- Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you POLIVY, which may prevent some infections, and will monitor your blood counts throughout treatment with POLIVY. Treatment with POLIVY can cause severe low blood cell counts
- Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
- Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
- Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication
Side effects seen most often
The most common side effects during treatment were
- Low blood cell counts (platelets, red blood cells, white blood cells)
- Nerve problems in arms and legs
- Tiredness or lack of energy
- Decreased appetite
POLIVY may not be for everyone. Talk to your doctor if you are
- Pregnant or think you are pregnant: Data have shown that POLIVY may harm your unborn baby
- Planning to become pregnant: Women should avoid getting pregnant while taking POLIVY. Women should use effective contraception during treatment and for at least 3 months after their last POLIVY treatment. Men taking POLIVY should use effective contraception during treatment and for at least 5 months after their last POLIVY treatment
- Breastfeeding: Women should not breastfeed while taking POLIVY and for at least 2 months after the last dose
These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of POLIVY treatment.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see the full Prescribing Information for additional Important Safety Information.
“Despite meaningful progress in the treatment of diffuse large B-cell lymphoma, treatment options are very limited when the disease is refractory to or recurrent after multiple regimens,” said Sandra Horning M.D., chief medical officer and head of Global Product Development. “Today’s approval of this Polivy combination will provide a novel treatment that is both immediately available and very much needed for people with this aggressive disease.”