FDA Grants Genentech’s Polivy Accelerated Approval for People with Previously Treated Aggressive LymphomaSource: Business Wire
– New targeted medicine shown to improve clinical outcomes in people with relapsed or refractory diffuse large B-cell lymphoma compared to a commonly used regimen –
– First-in-class antibody-drug conjugate that specifically targets CD79b, a protein expressed in the majority of B-cells –
Ninth indication with Breakthrough Therapy Designation in
Genentech’s hematology portfolio to receive
“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
“The approval of Polivy in combination with bendamustine and Rituxan
offers patients with relapsed or refractory diffuse large B-cell
lymphoma a new treatment option and new hope for improving patient
The accelerated approval of Polivy was based on the results from the Phase Ib/II GO29365 study. This is the first and only randomized pivotal clinical trial to show higher response rates over BR, a commonly used regimen, in people with R/R DLBCL who are ineligible for a hematopoietic stem cell transplant. Results of the study showed that 40 percent of people treated with Polivy plus BR achieved a complete response (n=16/40; 95 percent CI: 25-57), meaning no cancer could be detected at the time of assessment, compared to 18 percent with BR alone (n=7/40; 95 percent CI: 7-33). Complete response rates were assessed by independent review committee. The study also showed that 45 percent of people on Polivy plus BR achieved an objective response at the end of treatment (n=18/40; 95 percent CI: 29-62), compared to 18 percent of people treated with BR alone (n=7/40; 95 percent CI: 7-33). Of the people treated with Polivy plus BR who achieved a complete or partial response, 64 percent (n=16/25) had a duration of response (DOR) lasting at least six months as compared to 30 percent (n=3/10) of people treated with BR alone. Additionally, 48 percent (n=12/25) of people treated with Polivy plus BR had a DOR lasting at least a year as compared to 20 percent (n=2/10) of people treated with BR alone. Adverse reactions occurring in at least 20 percent of patients, and at least five percent more frequently in patients treated with Polivy plus BR compared to BR alone, included low white blood cell count, low platelet levels, low red blood cell count, numbness, tingling or pain in the hands and feet, diarrhea, fever, decreased appetite and pneumonia.
For those who qualify, Genentech will offer patient assistance programs for people taking Polivy and Rituxan through Genentech Access Solutions. Doctors can contact Genentech Access Solutions at (866) 422-2377. More information is also available at http://www.Genentech-Access.com.
About the GO29365 study
GO29365 is a global, Phase Ib/II randomized study evaluating the safety, tolerability and activity of Polivy (polatuzumab vedotin-piiq) in combination with bendamustine and Rituxan (rituximab) (BR) or Gazyva (obinutuzumab) in relapsed or refractory (R/R) follicular lymphoma or diffuse large B-cell lymphoma (DLBCL). Eligible patients were not candidates for hematopoietic stem cell transplant at study entry. The Phase II part of the study randomized 80 patients with heavily pre-treated R/R DLBCL to receive either BR, or BR in combination with Polivy for a fixed duration of six 21-day cycles. Patients enrolled had received a median of two prior therapies (a range of 1-7 prior therapies in the Polivy arm and range of 1-5 prior therapies in the BR alone arm). The primary endpoint was complete response (CR) at the end of treatment, as measured by positron emission tomography and assessed by an independent review committee (IRC). Secondary endpoints included overall response rate (ORR; CR and partial response) by investigator assessment and best ORR at the end of treatment by investigator and IRC assessment. Exploratory endpoints included duration of response (DOR), progression-free survival, event-free survival and overall survival.
About Polivy™ (polatuzumab vedotin-piiq)
Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The
CD79b protein is expressed specifically in the majority of B-cells, an
immune cell impacted in some types of non-Hodgkin’s lymphoma (
Diffuse large B-cell lymphoma (DLBCL) is the most common form of
non-Hodgkin’s lymphoma (
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 had at least two prior therapies.
The approval of Polivy is based on a type of response rate. There is an ongoing study 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.
- 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, which may prevent some infections, before giving Polivy and monitor blood counts throughout treatment with Polivy
- Infusion-related reactions: A patient may experience fever, chills, rash, or breathing problems within 24 hours of the infusion
- 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 numbness and tingling
- 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: Somesigns 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
- Decreased appetite
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 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.
About Genentech in Hematology
For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. Genentech now has five approved medicines in our broader hematology portfolio. For more information visit http://www.gene.com/hematology.
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
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