Dosing Schedule for Previously Untreated Follicular Lymphoma (FL)

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Standard Dosing Schedule¹

GAZYVA® (obinutuzumab) Dosing Schedule in Previously Untreated Follicular Lymphoma

Patients who achieve a complete or partial response to the initial 6 or 8 cycles of GAZYVA treatment in combination with chemotherapy should continue on GAZYVA 1,000 mg as monotherapy every 2 months for up to 2 years.

If a planned dose of GAZYVA is missed, administer the missed dose as soon as possible. During GAZYVA and chemotherapy treatment, adjust the dosing schedule accordingly to maintain the time interval between chemotherapy cycles. During monotherapy, maintain the original dosing schedule for subsequent doses. Monotherapy should be initiated approximately 2 months after the last induction dose of GAZYVA.

Administer GAZYVA with one of the following chemotherapy regimens:

Six 28-day cycles in combination with bendamustine
Six 21-day cycles in combination with CHOP, followed by 2 additional 21-day cycles of GAZYVA alone
Eight 21-day cycles in combination with CVP

GAZYVA 1,000 mg ~90-Minute Infusion May Save ~25-66 Hours Over a Full Course of Treatment Compared to Standard Infusion Rate for Eligible FL Patients^1,*

Assumes ~90-minute infusion initiated at Cycle 2 and continuation through induction and monotherapy for up to 17-19 infusions depending on chemo regimen.^† Standard dosing is ~3-5 hours/infusion. Infusion time may take longer if interrupted or slowed. This does not account for other aspects of treatment

GAZYVA® (obinutuzumab) ~90-Minute Infusion Rate in Previously Untreated Follicular Lymphoma

In patients with FL only who do not experience a Grade ≥ 3 IRR during Cycle 1, GAZYVA may be administered as a shorter, ~90-minute infusion from Cycle 2 onwards with continued premedication¹
If an IRR of Grade 1-2 with ongoing symptoms or a Grade 3 or higher IRR occurred during the previous ~90-minute infusion, administer GAZYVA at the standard infusion rate¹
GAZYVA ~90-minute infusion is administered at a rate of 100 mg/hr for 30 minutes, then 900 mg/hr for approximately 60 minutes¹
Of the 113 patients treated with GAZYVA, 88% (n=99) received the ~90-minute infusion starting in Cycle 2¹
— 76% (n=86) received GAZYVA monotherapy

^*~25 hours saved is based on seventeen ~90-minute infusions of GAZYVA + bendamustine regimen compared to ~3-hour standard infusion. ~66 hours saved is based on nineteen ~90-minute infusions of GAZYVA + CVP or CHOP regimens compared to ~5-hour standard infusion.^{1

†}Number and length of cycles depends on chemotherapy partner. Bendamustine requires 6 cycles every 28 days. CHOP requires 6 cycles every 21 days, followed by 2 cycles of only GAZYVA. CVP requires 8 cycles every 21 days.¹^‡Monotherapy is only for patients who achieved CR or PR at EOI.¹

GAZELLE Trial Design: ~90-Minute Infusion¹²

GAZELLE is an open-label, multicenter, Phase 4 study evaluating the safety and efficacy of GAZYVA as an ~90-minute infusion in eligible patients

GAZYVA was administered as an ~90-minute infusion in patients who did not have a Grade 3 or greater IRR in Cycle 1.

GAZYVA® (obinutuzumab) GAZELLE Trial Design in Previously Untreated Follicular Lymphoma

GAZYVA is approved as an ~90-minute infusion in 1L and R/R FL eligible patients starting with Cycle 2.^1,*

Primary endpoint: incidence of Grade ≥ 3 IRR during Cycle 2
Secondary endpoints include: safety, response, PFS, and overall survival

Chemotherapy regimen dosing for previously untreated FL¹

Bendamustine: When combined with GAZYVA, bendamustine is administered at 90 mg/m² IV on Days 1 and 2 with prednisone 100 mg orally or equivalent on Day 1 of Cycle 1 for six 28-day cycles
CVP: When combined with standard dosing of CVP, GAZYVA is administered over eight 21-day cycles
CHOP: When combined with standard dosing of CHOP, GAZYVA is administered over six 21-day cycles followed by 2 additional cycles of GAZYVA alone, for a total of 8 GAZYVA cycles
Patients who achieve a complete or partial response to the initial 6 or 8 cycles of GAZYVA treatment in combination with chemotherapy should continue on GAZYVA 1,000 mg as monotherapy every 2 months for up to 2 years

^*For eligible FL patients who do not experience a Grade ≥ 3 IRR in Cycle 1 or Grade 1-2 IRR with ongoing symptoms after initiating the ~90-minute infusion.¹

Dosing & Administration Guide

GAZYVA dosing schedule & infusion rates for previously untreated follicular lymphoma treatment

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Indications

GAZYVA^® (obinutuzumab), in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, is indicated for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma (FL).

GAZYVA^® (obinutuzumab), in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen.

GAZYVA^®(obinutuzumab), in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).

BOXED WARNINGS: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV-positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation
Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA

Contraindications

GAZYVA is contraindicated in patients with known hypersensitivity reactions (e.g. anaphylaxis) to obinutuzumab or to any of the excipients, or serum sickness with prior obinutuzumab use

Warnings and Precautions

Hepatitis B Virus Reactivation

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with anti-CD20 antibodies including GAZYVA. HBV reactivation has been reported in patients who are hepatitis B surface antigen (HBsAg) positive and in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation has also occurred in patients who appear to have resolved hepatitis B infection (ie, HBsAg negative, anti-HBc positive, and hepatitis B surface antibody [anti-HBs] positive)
HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level, or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, ie, increase in transaminase levels and, in severe cases, increase in bilirubin levels, liver failure, and death
Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with GAZYVA. For patients who show evidence of hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult healthcare providers with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy
Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following treatment with GAZYVA
In patients who develop reactivation of HBV while receiving GAZYVA, immediately discontinue GAZYVA and any concomitant chemotherapy and institute appropriate treatment. Resumption of GAZYVA in patients whose HBV reactivation resolves should be discussed with healthcare providers with expertise in managing hepatitis B. Insufficient data exist regarding the safety of resuming GAZYVA in patients who develop HBV reactivation

Progressive Multifocal Leukoencephalopathy (PML)

JC virus infection resulting in PML, which can be fatal, occurred in patients treated with GAZYVA. Consider the diagnosis of PML in any patient presenting with new onset or changes to preexisting neurologic manifestations. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Discontinue GAZYVA therapy and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML

Infusion-Related Reactions

GAZYVA can cause severe and life-threatening infusion-related reactions (IRRs). Sixty-five percent of patients with CLL experienced a reaction to the first 1,000 mg of GAZYVA infused. Thirty-seven percent of patients with relapsed or refractory NHL and 60% of patients with previously untreated NHL experienced a reaction on Day 1 of GAZYVA infusion. IRRs have occurred within 24 hours of receiving GAZYVA. IRRs can also occur with subsequent infusions. Symptoms may include hypotension, tachycardia, dyspnea, and respiratory symptoms (e.g., bronchospasm, larynx and throat irritation, wheezing, and laryngeal edema). The most frequently reported symptoms include nausea, fatigue, chest discomfort, dyspnea, dizziness, vomiting, diarrhea, rash, hypertension, hypotension, flushing, headache, pyrexia, and chills
Premedicate patients with acetaminophen, an antihistamine, and a glucocorticoid. Closely monitor patients during the entire infusion. Reduce infusion rate, interrupt infusion or permanently discontinue GAZYVA for IRRs based on severity. Institute medical management (e.g., glucocorticoids, epinephrine, bronchodilators, and/or oxygen) for IRRs as needed
For patients with preexisting cardiac or pulmonary conditions, monitor more frequently throughout the infusion and the post-infusion period since they may be at greater risk of experiencing more severe reactions. Hypotension may occur as part of the IRR to GAZYVA. Consider withholding antihypertensive treatments for 12 hours prior to, during each GAZYVA infusion, and for the first hour after administration until blood pressure is stable. For patients at increased risk of hypertensive crisis, consider the benefits versus the risks of withholding their antihypertensive medication

Hypersensitivity Reactions Including Serum Sickness

Hypersensitivity reactions have been reported in patients treated with GAZYVA. Signs of immediate-onset hypersensitivity included dyspnea, bronchospasm, hypotension, urticaria and tachycardia. Late-onset hypersensitivity diagnosed as serum sickness has also been reported, with symptoms that include chest pain, diffuse arthralgia and fever. Hypersensitivity reactions may be difficult to clinically distinguish from IRRs. However, hypersensitivity very rarely occurs with the first infusion and, when observed, often occurs after previous exposure
If a hypersensitivity reaction is suspected during or after an infusion, stop the infusion and permanently discontinue treatment. GAZYVA is contraindicated in patients with known hypersensitivity reactions to GAZYVA, including serum sickness with prior GAZYVA use

Tumor Lysis Syndrome (TLS)

Tumor lysis syndrome, including fatal cases, has been reported in patients receiving GAZYVA. Patients with high tumor burden, high circulating lymphocyte count (>25 x 10⁹/L) or renal impairment are at greater risk for TLS
Administer appropriate tumor lysis prophylaxis with antihyperuricemics (e.g. allopurinol or rasburicase) and hydration prior to the infusion of GAZYVA for patients at risk for TLS. During the initial days of GAZYVA treatment, monitor the laboratory parameters of patients considered at risk for TLS. For treatment of TLS, correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated

Infections

Fatal and serious bacterial, fungal, and new or reactivated viral infections can occur during and following GAZYVA therapy. When GAZYVA is administered with chemotherapy followed by GAZYVA monotherapy, Grade 3 to 5 infections have been reported in up to 8% of patients during combination therapy, up to 13% of patients during monotherapy, and up to 8% of patients after treatment
In GALLIUM, more Grade 3 to 5 infections were reported in the recipients of GAZYVA and bendamustine (117/410 patients, 29%), as compared to GAZYVA plus CHOP or CVP (43/281 patients, 15%). More fatal infections were reported in patients treated with GAZYVA and bendamustine (3%), as compared to GAZYVA plus CHOP or CVP (<1%), including during the monotherapy phase and after completion of treatment
Do not administer GAZYVA to patients with an active infection. Patients with a history of recurring or chronic infections may be at increased risk of infection

Neutropenia

Severe and life-threatening neutropenia, including febrile neutropenia, has been reported during treatment with GAZYVA. Monitor patients with Grade 3 to 4 neutropenia frequently with regular laboratory tests until resolution. Anticipate, evaluate, and treat any symptoms or signs of developing infection. Consider dose delays for Grade 3 or 4 neutropenia. Consider administration of granulocyte colony-stimulating factors (GCSF) in patients with Grade 3 or 4 neutropenia
Neutropenia can also be of late onset (occurring more than 28 days after completion of treatment) and/or prolonged (lasting longer than 28 days)
Patients with severe and long lasting (>1 week) neutropenia are strongly recommended to receive antimicrobial prophylaxis until resolution of neutropenia to Grade 1 or 2. Consider antiviral and antifungal prophylaxis

Thrombocytopenia

Severe and life-threatening thrombocytopenia has been reported during treatment with GAZYVA in combination with chemotherapy. Fatal hemorrhagic events have been reported in patients with NHL treated with GAZYVA in combination with chemotherapy, including during Cycle 1
Monitor all patients frequently for thrombocytopenia and hemorrhagic events, especially during the first cycle and if clinically indicated, evaluate laboratory coagulation parameters. In patients with Grade 3 or 4 thrombocytopenia, monitor platelet counts more frequently until resolution and consider dose delays of GAZYVA and chemotherapy or dose reductions of chemotherapy. Transfusion of blood products (i.e., platelet transfusion) may be necessary. Consider withholding concomitant medications that may increase bleeding risk (platelet inhibitors or anticoagulants), especially during the first cycle

Disseminated Intravascular Coagulation (DIC)

Fatal and severe DIC has been reported in patients receiving GAZYVA for treatment of follicular lymphoma and chronic lymphocytic leukemia. The majority of DIC cases have involved changes in platelets and laboratory coagulation parameters following the first infusion, with spontaneous resolution usually occurring by Day 8. In some cases, DIC was associated with IRRs, TLS, or both. In patients with suspected DIC, evaluate potential causes, and monitor coagulation parameters, platelet counts, and for signs and symptoms of bleeding or thrombosis. Manage according to standard guidelines for DIC. Supportive care, including transfusion of blood products and other medical management, may be necessary

Immunization

The safety and efficacy of immunization with live or attenuated viral vaccines during or following GAZYVA therapy have not been studied. Immunization with live virus vaccines is not recommended during treatment and until B-cell recovery

Embryo-Fetal Toxicity

Based on its mechanism of action and findings in animals, GAZYVA can cause B-cell depletion in infants exposed to obinutuzumab in-utero. Advise pregnant women of the potential risk to a fetus. Mothers who have been exposed to GAZYVA during pregnancy should discuss the safety and timing of live virus vaccinations for their infants with their child’s healthcare providers. Advise females of reproductive potential to use effective contraception while receiving GAZYVA and for 6 months after the last dose

Lactation

Human IgG is known to be present in human milk. Because of the potential of serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with GAZYVA and for 6 months after the last dose

Geriatric Use

Of 336 patients with previously untreated CLL who received GAZYVA in combination with chlorambucil, 81% were 65 years and older, while 46% were 75 and older. Of the patients 75 years and older, 46% experienced serious adverse reactions and 7% experienced adverse reactions leading to death. Of the patients younger than 75, 33% experienced a serious adverse reaction and 2% an adverse reaction leading to death. No significant differences in efficacy were observed between younger and older patients
Of 204 patients in GADOLIN with relapsed or refractory NHL treated with GAZYVA plus bendamustine, 44% were 65 and over, while 14% were 75 and over. In patients 65 and over, 55% of patients experienced serious adverse reactions and 28% experienced adverse reactions leading to treatment withdrawal while in patients under 65, 37% and 14% experienced serious adverse reactions and adverse reactions leading to treatment withdrawal, respectively. No clinically meaningful differences in efficacy were observed between these patients and younger patients in GADOLIN
Of the 691 patients in GALLIUM treated with GAZYVA plus chemotherapy as first-line therapy, 33% were 65 and over, while 7% were 75 and over. Of patients 65 and over, 63% experienced serious adverse reactions and 26% experienced adverse reactions leading to treatment withdrawal, while in patients under 65, 43% experienced serious adverse reactions and 13% had an adverse reaction leading to treatment withdrawal. No clinically meaningful differences in efficacy were observed between these patients and younger patients

Additional Important Safety Information

Previously Untreated CLL

The most common Grade 3 to 4 adverse reactions (incidence ≥10%) observed in patients with CLL in the GAZYVA containing arm were neutropenia, infusion-related reactions, and thrombocytopenia
The most common adverse reactions (incidence ≥10%) observed in patients with CLL in the GAZYVA containing arm were infusion-related reactions, neutropenia, thrombocytopenia, and diarrhea
Adverse reactions rates and laboratory abnormalities from the Stage 2 phase are consistent with the rates in Stage 1. In addition to the adverse reactions observed in Stage 2, in Stage 1 back pain (5% vs 2%), anemia (12% vs 10%) and cough (10% vs 7%) were observed at a higher incidence in the GAZYVA treated patients. The incidence of Grade 3 to 4 back pain (<1% vs 0%), cough (0% vs <1%) and anemia (5% vs 4%) was similar in both treatment arms. With regard to laboratory abnormalities, in Stage 1 hyperkalemia (33% vs 18%), creatinine increased (30% vs 20%) and alkaline phosphatase increased (18% vs 11%) were observed at a higher incidence in patients treated with GAZYVA with similar incidences of Grade 3 to 4 abnormalities between the two arms

Relapsed/Refractory NHL

The GADOLIN study evaluated safety in 407 patients with relapsed or refractory NHL, including FL (81%), small lymphocytic lymphoma (SLL) and marginal zone lymphoma (MZL) (a disease for which GAZYVA is not indicated), who did not respond to or progressed within 6 months of treatment with rituximab product or a rituximab product-containing regimen. In patients with follicular lymphoma, the profile of adverse reactions was consistent with the overall NHL population
Serious adverse reactions occurred in 45% of the GAZYVA arm and 37% of the bendamustine-only arm. Fatal adverse reactions within 90 days of treatment occurred in 3.4% and 2.5%, respectively. Throughout follow-up, fatal adverse reactions occurred in 10% of GAZYVA recipients and in 7.4% of recipients of bendamustine alone, with infection and second primary malignancies being the leading causes
The most common adverse reactions (incidence ≥20%) in GAZYVA recipients included infusion-related reactions, fatigue, neutropenia, cough, upper respiratory tract infections, and musculoskeletal pain
During GAZYVA monotherapy (160 patients), adverse reactions in ≥10% of patients included upper and lower respiratory tract infections, cough, neutropenia, musculoskeletal pain, fatigue, diarrhea, rash, and urinary tract infection
In the GAZYVA monotherapy phase, new or worsening grade 3 or 4 abnormalities included neutropenia in 25% of patients (Grade 4, 10%) and lymphopenia in 23% (Grade 4, 5%)

Previously Untreated NHL

A randomized, open-label multicenter trial (GALLIUM) evaluated the safety of GAZYVA as compared to rituximab product in 1385 patients with previously untreated follicular lymphoma (86%) or marginal zone lymphoma (14%)
Serious adverse reactions occurred in 50% of patients on the GAZYVA arm and 43% of patients on the rituximab product arm. Fatal adverse reactions were reported during treatment in 3% in the GAZYVA arm and 2% in the rituximab product arm, most often from infections in the GAZYVA arm. During treatment and follow-up combined, fatal adverse reactions were reported in 5% of the GAZYVA arm and 4% of the rituximab product arm, with infections and second malignancies being leading causes. In the GAZYVA arm, fatal infections occurred in 2% of patients compared to <1% in the rituximab product arm
Neutropenia, infusion-related reactions, febrile neutropenia and thrombocytopenia were the most common Grade 3 to 5 adverse reactions (incidence ≥5%) observed more frequently in the GAZYVA arm
Throughout treatment and follow-up, the most common adverse reactions (incidence ≥20%) observed at least 2% more in the GAZYVA arm were infusion-related reactions (72%), neutropenia (53%), upper respiratory tract infection (50%), cough (35%), constipation (32%) and diarrhea (30%)
During the monotherapy period, the common adverse reactions (incidence ≥10%) observed at least 2% more with GAZYVA were upper respiratory infection (40%), cough (23%), musculoskeletal pain (20%), neutropenia (19%) and herpesvirus infection (13%)

You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch, or calling 1-800-FDA-1088.

Please see the full Prescribing Information for additional Important Safety Information, including BOXED WARNINGS.

- GAZYVA full Prescribing Information. South San Francisco, CA: Genentech, Inc.; 2022.
  
  GAZYVA full Prescribing Information. South San Francisco, CA: Genentech, Inc.; 2022.
- Mössner E, Brünker P, Moser S, et al. Increasing the efficacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cell–mediated B-cell cytotoxicity. Blood. 2010;115(22):4393-4402.
  
  Mössner E, Brünker P, Moser S, et al. Increasing the efficacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cell–mediated B-cell cytotoxicity. Blood. 2010;115(22):4393-4402.
- Herter S, Herting F, Mundigl O, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013;12(10):2031-2042.
  
  Herter S, Herting F, Mundigl O, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013;12(10):2031-2042.
- Klein C, Lammens A, Schäfer W, et al. Epitope interactions of monoclonal antibodies targeting CD20 and their relationship to functional properties. mAbs. 2013;5(1):22-33.
  
  Klein C, Lammens A, Schäfer W, et al. Epitope interactions of monoclonal antibodies targeting CD20 and their relationship to functional properties. mAbs. 2013;5(1):22-33.
- Honeychurch J, Alduaij W, Azizyan M, et al. Antibody-induced nonapoptotic cell death in human lymphoma and leukemia cells is mediated through a novel reactive oxygen species-dependent pathway. Blood. 2012;119(15):3523-3533.
  
  Honeychurch J, Alduaij W, Azizyan M, et al. Antibody-induced nonapoptotic cell death in human lymphoma and leukemia cells is mediated through a novel reactive oxygen species-dependent pathway. Blood. 2012;119(15):3523-3533.
- VENCLEXTA^® (venetoclax tablets) Prescribing Information. North Chicago, IL: AbbVie Inc; 2022.
  
  VENCLEXTA^® (venetoclax tablets) Prescribing Information. North Chicago, IL: AbbVie Inc; 2022.
- CALQUENCE^® (acalabrutinib) Prescribing Information. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  
  CALQUENCE^® (acalabrutinib) Prescribing Information. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
- IMBRUVICA^® (ibrutinib) Prescribing Information. Horsham, PA: Janssen Biotech, Inc.; 2022.
  
  IMBRUVICA^® (ibrutinib) Prescribing Information. Horsham, PA: Janssen Biotech, Inc.; 2022.
- Data on file. Genentech, Inc.
  
  Data on file. Genentech, Inc.
- Seymour JF, Marcus R, Davies A, et al. Haematologica. 2019;104(6):1202-1208.
  
  Seymour JF, Marcus R, Davies A, et al. Haematologica. 2019;104(6):1202-1208.
- Casulo C, Byrtek M, Dawson KL, et al. J Clin Oncol. 2015;33(23):2516-2522.
  
  Casulo C, Byrtek M, Dawson KL, et al. J Clin Oncol. 2015;33(23):2516-2522.
- Canales M, Buchholz T, Izutsu K, et al. Obinutuzumab short duration infusion in previously untreated advanced follicular lymphoma: results from the end of induction analysis of the phase IV GAZELLE study. Presented at ASCO 2021.
  
  Canales M, Buchholz T, Izutsu K, et al. Obinutuzumab short duration infusion in previously untreated advanced follicular lymphoma: results from the end of induction analysis of the phase IV GAZELLE study. Presented at ASCO 2021.