South San Francisco, CA — February 26, 2016 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment. Follicular lymphoma is the most common type of indolent (slow-growing) non-Hodgkin’s lymphoma (NHL) and accounts for approximately one in five cases of NHL.
“People with follicular lymphoma whose disease returns or worsens despite treatment with a Rituxan-containing regimen need more options because the disease becomes more difficult to treat each time it comes back,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Gazyva plus bendamustine provides a new treatment option that can be used after relapse to significantly reduce the risk of progression or death.”
The approval is based on results from the Phase III GADOLIN study, which showed that, in people with follicular lymphoma whose disease progressed during or within six months of prior Rituxan-based therapy, Gazyva plus bendamustine followed by Gazyva alone demonstrated a 52 percent reduction (HR=0.48, 95 percent CI 0.34-0.68, p<0.0001) in the risk of disease worsening or death (progression-free survival, PFS), compared to bendamustine alone, as assessed by an independent review committee (IRC). The supplemental Biologics License Application based on these data was granted Priority Review, a designation granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
The safety of Gazyva was evaluated based on 392 people in the GADOLIN study with indolent NHL of whom 81 percent had follicular lymphoma. The most common Grade 3-4 side effects of this Gazyva regimen were low white blood cell counts, infusion reactions and low platelet counts. The most common side effects of this Gazyva regimen were infusion reactions, low white blood cell counts, nausea, fatigue, cough, diarrhea, constipation, fever, low platelet counts, vomiting, upper respiratory tract infection, decreased appetite, joint or muscle pain, sinusitis, low red blood cell counts, general weakness and urinary tract infection.
With this approval, Gazyva is approved in the United States to treat two common types of blood cancer. Gazyva is also approved in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia (CLL) based on data from the pivotal CLL11 study, which compared Gazyva plus chlorambucil head-to-head with Rituxan plus chlorambucil.
Marketing applications for Gazyva based on the GADOLIN study results have also been submitted to other regulatory authorities, including the European Medicines Agency (EMA), for approval consideration.
For those who qualify, Genentech offers patient assistance programs for people taking Gazyva through Genentech Access Solutions.
About the GADOLIN Study
GADOLIN (NCT01059630; GA04753g) is a Phase III open-label, multicenter, randomized two-arm study evaluating Gazyva plus bendamustine followed by Gazyva alone until disease progression or for up to two years compared to bendamustine alone. GADOLIN included 413 patients with indolent (slow-growing) non-Hodgkin’s lymphoma (NHL), including 321 patients with follicular lymphoma, whose disease progressed during or within six months of prior Rituxan-based therapy. The primary endpoint of the study is progression-free survival (PFS) as assessed by an independent review committee (IRC), with secondary endpoints including PFS as assessed by investigator review, best overall response (BOR), complete response (CR), partial response (PR), duration of response, overall survival (OS) and safety profile. Results in follicular lymphoma showed:
- The Gazyva regimen improved PFS compared to bendamustine alone, as assessed by IRC (HR=0.48, 95 percent CI 0.34-0.68, p<0.0001). Median PFS was not reached in those receiving the Gazyva regimen versus 13.8 months in those receiving bendamustine alone.
- Investigator-assessed PFS was consistent with IRC-assessed PFS. As assessed by investigator review, median PFS with the Gazyva regimen was more than double that with bendamustine alone (29.2 months vs. 13.7 months; HR=0.48, 95 percent CI 0.35-0.67, p<0.0001).
- In addition, BOR for those receiving the Gazyva regimen was 78.7 percent (15.5 percent CR, 63.2 percent PR) compared to 74.7 percent for those receiving bendamustine alone (18.7 percent CR, 56 percent PR), as assessed by IRC.
- The median duration of response was not reached for those receiving the Gazyva regimen and was 11.6 months for those receiving bendamustine alone.
- The Gazyva regimen reduced the risk of death (OS) by 38 percent compared to bendamustine alone based on a post-hoc analysis with 24.1 months of median observation time (HR=0.62, 95 percent CI 0.39-0.98). The median OS has not yet been reached in either study arm.
- The most common Grade 3-4 side effects observed in those receiving the Gazyva regimen were low white blood cell counts (33 percent), infusion reactions (11 percent) and low platelet counts (10 percent). The most common side effects were infusion reactions (69 percent), low white blood cell counts (35 percent), nausea (54 percent), fatigue (39 percent), cough (26 percent), diarrhea (27 percent), constipation (19 percent), fever (18 percent), low platelet counts (15 percent), vomiting (22 percent), upper respiratory tract infection (13 percent), decreased appetite (18 percent), joint or muscle pain (12 percent), sinusitis (12 percent), low red blood cell counts (12 percent), general weakness (11 percent) and urinary tract infection (10 percent).
About Follicular Lymphoma
Follicular lymphoma is the most common indolent (slow-growing) form of non-Hodgkin’s lymphoma (NHL), accounting for about one in five cases of NHL. It is considered incurable and relapse is common. In the United States, it was estimated that more than 14,000 new cases of follicular lymphoma would be diagnosed in 2015.
About Genentech Access Solutions
Access Solutions is part of Genentech’s commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of 350 in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process, and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 1.2 million patients access the medicines they need. Please contact Access Solutions (866) 4ACCESS/(866) 422-2377 or visit http://www.Genentech-Access.com for more information.
Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on B-cells. It attacks targeted cells both directly and together with the body’s immune system. Gazyva was discovered by Roche Glycart AG, a wholly owned, independent research unit of Roche. In the United States, Gazyva is part of a collaboration between Genentech and Biogen.
Gazyva is being studied in a large clinical program, including the Phase III GOYA and GALLIUM studies. GOYA is comparing Gazyva head-to-head with Rituxan plus CHOP chemotherapy in first line diffuse large B-cell lymphoma (DLBCL) and GALLIUM is comparing Gazyva plus chemotherapy head-to-head with Rituxan plus chemotherapy in first line indolent non-Hodgkin’s lymphoma (NHL). Additional combination studies investigating Gazyva with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are planned or underway across a range of blood cancers.
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. In addition to approved medicines Rituxan® (rituximab) and Gazyva® (obinutuzumab), Genentech’s pipeline of investigational hematology medicines includes an anti-PDL1 antibody (atezolizumab/MPDL3280A), an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596), a small molecule antagonist of MDM2 (idasanutlin/RG7388) and in collaboration with AbbVie, a small molecule BCL-2 inhibitor (venetoclax/RG7601/GDC-0199/ABT-199). Genentech’s dedication to developing novel medicines for blood diseases expands beyond oncology, with the development of the investigational hemophilia A treatment emicizumab (ACE910).
Founded 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or 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.
Posted: February 2016
Source: FDA New Drug Approvals