• GAZYVA + bendamustine followed by GAZYVA monotherapy was evaluated vs bendamustine alone in a Phase III , randomized , controlled trial in follicular lymphoma patients who had no response to or who progressed within 6 months of therapy with a rituximab-containing regimen

• Patients in the GAZYVA + bendamustine arm who did not have disease progression ( patients with a complete response , partial response , or stable disease ) at the end of the 6 cycles continued receiving GAZYVA monotherapy for 2 years unless disease progression occurred during the treatment

In follicular lymphoma patients who were refractory to a rituximab-containing regimen

Primary endpoint : IRC-assessed PFS

GAZYVA + bendamustine followed by GAZYVA monotherapy

0.0 0 6 12 18 24 30 36 42 48 54

Time ( months ) n at risk 155

120 79 61 38 20 6 2 1

Bendamustine

166

122 66 29 17 7 2 1

IRC , independent review committee ; HR , hazard ratio ; CI , confidence interval .

Pregnancy

• There are no data with GAZYVA use in pregnant women to inform a drug-associated risk . GAZYVA is likely to cause fetal B-cell depletion . GAZYVA should be used during pregnancy and / or breastfeeding only if the potential benefit justifies the potential risk to the fetus and / or infant . 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

Geriatric Use

• Of 194 patients with iNHL treated with GAZYVA plus bendamustine , 44 % were 65 and over , while 14 % were 75 and over . In patients 65 and over , 52 % of patients experienced serious adverse events and 26 % experienced adverse events leading to treatment withdrawal while in patients under 65 , 28 % and 12 % experienced serious adverse events and adverse events leading to treatment withdrawal , respectively . No clinically meaningful differences in safety and efficacy were observed between these patients and younger patients

Additional Important Safety Information

• The safety of GAZYVA was evaluated based on a safety population of 392 patients with indolent NHL ( iNHL ), of whom 81 % had follicular lymphoma . In patients with follicular lymphoma , the most common adverse reactions that were seen were consistent with the overall population who had iNHL

• Grade 3 / 4 adverse reactions were : neutropenia ( 33 %), infusion reactions ( 11 %), thrombocytopenia ( 10 %), urinary tract infection ( 3 %), upper respiratory tract infection ( 2 %), pyrexia ( 1 %), asthenia ( 1 %), sinusitis ( 1 %), and pain in extremity ( 1 %)

• The most common adverse reactions ( incidence ≥10 %) were : infusion reactions ( 69 %), neutropenia ( 35 %), nausea ( 54 %), fatigue ( 39 %), cough ( 26 %), diarrhea ( 27 %), constipation ( 19 %), pyrexia ( 18 %), thrombocytopenia ( 15 %), vomiting ( 22 %), upper respiratory tract infection ( 13 %), decreased appetite ( 18 %), arthralgia ( 12 %), sinusitis ( 12 %), anemia ( 12 %), asthenia ( 11 %), and urinary tract infection ( 10 %)

• During the monotherapy period with GAZYVA , the most common Grade 3-4 adverse reactions were neutropenia ( 10 %), and anemia , febrile neutropenia , thrombocytopenia , sepsis , upper respiratory tract infection , and urinary tract infection ( all at 1 %)