Genentech Statement on FDA Oncologic Drug Advisory Meeting on March 9, 2023

South San Francisco, CA — January 25th, 2023 —

Genentech will participate in the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) meeting on March 9, 2023 to discuss the supplemental Biologics License Application (sBLA) for Polivy^® (polatuzumab vedotin-piiq) in combination with Rituxan^® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). The sBLA submission is based on pivotal data from the Phase III POLARIX study, a multicentre, randomized, double-blinded, placebo-controlled clinical trial of more than 800 patients. Study results showed a 27% reduction in the risk of disease worsening or death with Polivy plus R-CHP compared to standard-of-care R-CHOP in first-line DLBCL. Overall survival data was immature. The safety profile was comparable for Polivy plus R-CHP versus R-CHOP*. The FDA is expected to make a decision on approval by April 2, 2023.

DLBCL is an aggressive, hard to treat disease and is the most common form of non-Hodgkin's lymphoma in the U.S. Four in ten people do not respond to treatment, and the majority of those who require subsequent lines of therapy have poor outcomes. Limited progress has been made over the last two decades in improving the current standard of care in the first-line setting. We look forward to continued collaboration with the FDA and discussions with the advisory committee to support the application process.

*Including rates of Grade 3-4 adverse events (AEs; 57.7% versus 57.5%), serious AEs (34.0% versus 30.6%), Grade 5 AEs (3.0% versus 2.3%), and AEs leading to dose reduction (9.2% versus 13.0%).

Polivy U.S. Indication

Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat diffuse large B-cell lymphoma in adults who have progressed after at least two prior therapies.

The accelerated approval of Polivy is based on a type of response rate. There are ongoing studies to confirm the clinical benefit of Polivy.

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. A patient’s doctor may stop or adjust a patient’s treatment if any serious side effects occur. Patients must contact their healthcare team if there are any signs of these side effects.

• Nerve problems in arms and legs: This may happen as early as after the first dose and may worsen with every dose. If a patient already has nerve pain, Polivy may make it worse. The patient’s doctor will monitor for signs and symptoms, such as changes in sense of touch, numbness or tingling in hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to walking patterns

• Infusion-related reactions: A patient may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of the infusion

• Infections: Patients should contact their healthcare team if they experience a fever of 100.4°F or higher, chills, cough, or pain during urination. Also, a patient’s doctor may give medication before giving Polivy, which may prevent some infections, and monitor blood counts throughout treatment with Polivy. Treatment with Polivy can cause severe low blood cell counts

• Rare and serious brain infections: A patient’s doctor will monitor the patient closely for signs and symptoms of these types of infections. Patients should contact their doctor if they 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 the skin or the white part of the eyes. Patients may be at higher risk if they already have liver problems or 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
• Diarrhea
• Nausea
• Fever
• Decreased appetite
• Infections

Polivy may not be for everyone. A patient should talk to their doctor if they are:

• Pregnant or may be pregnant: Data have shown that Polivy may harm an 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. Patients should talk to their healthcare provider for more information about the benefits and risks of Polivy treatment.

Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please visit http://www.Polivy.com for the full Prescribing Information for additional Important Safety Information.

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About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.