Relapsed or refractory diffuse large B-cell lymphoma

Active Ingredient: Odronextamab

Indication for Odronextamab

Population group: only adults (18 years old or older)

Therapeutic intent: Curative procedure

Odronextamab as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after two or more lines of systemic therapy.

For this indication, competent medicine agencies globally authorize below treatments:

0.2-10 mg step-up dosing on Cycle 1, 160 mg on Day 1, 8 and 15 of Cycles 2 to 4, and thereafter 320 mg every 2 weeks

For:

Dosage regimens

Intravenous, 0.2 milligrams odronextamab, one dose, over the duration of 1 day. Afterwards, intravenous, 0.5 milligrams odronextamab, one dose, over the duration of 6 days. Afterwards, intravenous, 2 milligrams odronextamab, one dose, over the duration of 1 day. Afterwards, intravenous, 2 milligrams odronextamab, one dose, over the duration of 6 days. Afterwards, intravenous, 10 milligrams odronextamab, one dose, over the duration of 1 day. Afterwards, intravenous, 10 milligrams odronextamab, one dose, over the duration of 5 days. Afterwards, intravenous, 160 milligrams odronextamab, once every 7 days, one dose, over the duration of 21 days. This step is repeated 2 times. Afterwards, intravenous, 160 milligrams odronextamab, once every 7 days, 3 doses in total, over the duration of 28 days. Afterwards, intravenous, 320 milligrams odronextamab, once every 2 weeks, 3 doses in total, over the duration of 9 months. Afterwards, intravenous, 320 milligrams odronextamab, once every 4 weeks.

Detailed description

Prophylaxis, premedications, and post-medications for the treatment of patients with r/r FL or r/r DLBCL

Odronextamab should be administered to well-hydrated patients.

Premedications must be administered for each dose in Cycle 1 and Cycle 2, Days 1 and 8 and post-medications for Cycle 1, Days 3, 10, and 17 and Cycle 2, Day 2 as described in Table 1 to reduce the risk of cytokine release syndrome (CRS) or infusion-related reactions (IRR). Premedications may be continued beyond Cycle 2, Day 8 until the dose is tolerated without experiencing CRS or IRR. In addition, prophylaxis is recommended to reduce the risk of infection, tumour lysis syndrome (TLS), and corticosteroid-induced gastrointestinal (GI) adverse reactions.

Table 1. Premedications and post-medications for patients with r/r FL or r/r DLBCL:

Treatment cycle and day	Medication	Dose	Administration relative to odronextamab infusion
Cycle 1: Days 1, 2, 8, 9, 15, and 16	Corticosteroid	Dexamethasone 10 mg oral or equivalent Omit on days 2, 9, and 16 if infusions are given on consecutive days.	12 to 24 hours prior to infusion
	Corticosteroid	Dexamethasone 20 mg intravenous	1 to 3 hours prior to infusion
	Antihistamine	Diphenhydramine hydrochloride 25 mg oral or intravenous or equivalent antihistamine	30 to 60 minutes prior to infusion
	Antipyretic	Paracetamol 650 mg to 1 000 mg oral	30 to 60 minutes prior to infusion
Cycle 1: Days 3, 10, and 17	Corticosteroid	Dexamethasone 10 mg oral or equivalent	24 hours after infusion
Cycle 2: Day 1	Corticosteroid	Dexamethasone 10 mg oral or equivalent	12 to 24 hours prior to infusion
	Corticosteroid	Dexamethasone 20 mg intravenous	1 to 3 hours prior to infusion
	Antihistamine	Diphenhydramine hydrochloride 25 mg oral or intravenous or equivalent antihistamine	30 to 60 minutes prior to infusion
	Antipyretic	Paracetamol 650 mg to 1 000 mg oral	30 to 60 minutes prior to infusion
Cycle 2: Day 2	Corticosteroid	Dexamethasone 10 mg oral or equivalent	24 hours after infusion
Cycle 2: Day 8	Corticosteroid	Dexamethasone 10 mg* intravenous	1 to 3 hours prior to infusion
	Antihistamine	Diphenhydramine hydrochloride 25 mg oral or intravenous or equivalent antihistamine	30 to 60 minutes prior to infusion
	Antipyretic	Paracetamol 650 mg to 1 000 mg oral	30 to 60 minutes prior to infusion

^* If CRS or IRR occurs with the Cycle 2 Day 1 dose, administer dexamethasone 20 mg intravenously for the next dose until the dose is tolerated without experiencing CRS or IRR.

Recommended dose

The recommended dose for odronextamab is presented in Table 2. For Cycles 1 to 4, a treatment cycle is 21 days. Each dose should only be administered if the previous dose is tolerated.

Odronextamab should be administered until disease progression or unacceptable toxicity.

Table 2. Recommended dose:

		r/r FL	r/r DLBCL
Day of treatment		Dose of odronextamab		Duration of infusion
Cycle 1^a (Step-up dosing)	Day 1	0.2 mg		Administer odronextamab as a 4-hour infusion.
	Day 2	0.5 mg
	Day 8	2 mg
	Day 9	2 mg
	Day 15	10 mg
	Day 16	10 mg
Cycles 2 to 4^a	Day 1	80 mg	160 mg	Administer odronextamab as a 4-hour infusion on Cycle 2, Day 1. If tolerated, for all subsequent doses starting on Cycle 2, Day 8, infusion time can be reduced to 1 hour.
	Day 8	80 mg	160 mg
	Day 15	80 mg	160 mg
Maintenance (Every 2 weeks)	Begin 1 week after the end of Cycle 4	160 mg	320 mg	Administer odronextamab as a 1-hour infusion every two weeks until disease progression or unacceptable toxicity.
Maintenance (Every 4 weeks)	If a patient is in complete response (CR) for 9 months, administer the odronextamab maintenance dose every 4 weeks.	160 mg	320 mg	Administer odronextamab as a 1-hour infusion every 4 weeks until disease progression or unacceptable toxicity.

r/r FL=relapsed or refractory follicular lymphoma; r/r DLBCL=relapsed or refractory diffuse large
B-cell lymphoma
^a For Cycles 1 to 4, a treatment cycle is 21 days.

Recommendations for restarting therapy with odronextamab after a dose delay in patients with r/r FL or r/r DLBCL

Table 3 provides recommendations for restarting therapy after a dose delay.

Table 3. Recommendations for restarting therapy with odronextamab after a dose delay:

Cycle	Day	Last dose administered	Time since the last dose administered	Action for next dose
1	1	0.2 mg	Greater than 3 days	Restart from 0.2 mg (Cycle 1, Day 1)
	2	0.5 mg	Less than 2 weeks	Administer next scheduled dose^a
	2	0.5 mg	2 weeks or longer	Restart from 0.2 mg (Cycle 1, Day 1)
	8 and 9	2 mg	Less than 3 weeks	Administer next scheduled dose^a
			3 to 4 weeks	Administer 2 mg (Cycle 1, Day 9), then resume the planned treatment schedule.
			Greater than 4 weeks	Restart from 0.2 mg (Cycle 1, Day 1)
	15 and 16	10 mg	Less than 3 weeks	Administer next scheduled dose^a
			3 to 5 weeks	Administer 10 mg (Cycle 1, Day 16), and then resume the planned treatment schedule.
			Greater than 5 weeks	Restart from 0.2 mg (Cycle 1, Day 1)
2 to 4	1, 8, 15	• r/r FL: 80 mg • r/r DLBCL: 160 mg	Less than 7 weeks	Administer next scheduled dose^a
			7 to 10 weeks	Administer 10 mg (Cycle 1, Day 16), then resume the planned treatment schedule.
			Greater than 10 weeks	Restart from 0.2 mg (Cycle 1, Day 1)
Maintenance	Every 2 weeks OR Every 4 weeks after CR maintained for 9 months	• r/r FL: 160 mg • r/r DLBCL: 320 mg	Less than 7 weeks	Administer next scheduled dose^a
			7 to 10 weeks	Administer 10 mg (Cycle 1, Day 16), then resume the planned treatment schedule.
			Greater than 10 weeks	Restart from 0.2 mg (Cycle 1, Day 1)

NOTE: Administer premedications and post-medications as per Table 1.
r/r FL=relapsed or refractory follicular lymphoma; r/r DLBCL=relapsed or refractory diffuse large
B-cell lymphoma
^a As per Table 2, resume the treatment schedule without skipping doses.

Dosage considerations

The first cycle of odronextamabodronextamab is administered as a 4-hour infusion. If odronextamab is tolerated on Cycle 2, Day 1, infusion time can be reduced to 1 hour for all subsequent doses. Refer to Table 2.
Odronextamab should be administered as an intravenous infusion through a dedicated infusion line.
Odronextamab must not be administered as intravenous push or bolus.
See Table 1 for premedications and post-medications.

Active ingredient

Odronextamab
Read more about Odronextamab

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