ZYNLONTA (Page 5 of 6)

14 CLINICAL STUDIES

14.1 Relapsed or Refractory Diffuse Large B-cell Lymphoma

The efficacy of ZYNLONTA was evaluated in LOTIS-2 (NCT03589469), an open-label, single-arm trial in 145 adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least 2 prior systemic regimens. The trial excluded patients with bulky disease and active central nervous system lymphoma. Patients received ZYNLONTA 0.15 mg/kg every 3 weeks for 2 cycles, then 0.075 mg/kg every 3 weeks for subsequent cycles and received treatment until progressive disease, or unacceptable toxicity.

Of the 145 patients enrolled, the median age was 66 years (range 23 to 94), 59% male, and 94% had an ECOG performance status of 0 to 1. Race was reported in 97% of patients; of these patients, 90% were White, 3% were Black, and 2% were Asian. The diagnosis was DLBCL not otherwise specified (NOS) in 88% (including 20% with DLBCL arising from low-grade lymphoma) and high-grade B-cell lymphoma in 7%. The median number of prior therapies was 3 (range 2 to 7), 63% with refractory disease, 17% with prior stem cell transplant, and 9% with prior chimeric antigen receptor (CAR) T-cell therapy.

Efficacy was established on the basis of overall response rate (ORR) as assessed by an Independent Review Committee (IRC) using Lugano 2014 criteria (Table 4). The median follow-up time was 7.3 months (range 0.3 to 20.2).

Table 4 Efficacy Results in Patients with Relapsed or Refractory DLBCL
Efficacy Parameter ZYNLONTA N = 145
CI = confidence interval, NE = not estimable
*
IRC = independent review committee using Lugano 2014 criteria
Of 70 patients with objective response, 25 (36%) were censored prior to 3 months. Twenty- six percent of responders had a duration of response ≥6 months
Overall response rate by IRC *, (95% CI) 48.3% (39.9, 56.7)
Complete response rate (95% CI) 24.1% (17.4, 31.9)
Partial response rate (95% CI) 24.1% (17.4, 31.9)
Duration of overall response N = 70
Median (95% CI), months 10.3 (6.9, NE)

The median time to response was 1.3 months (range 1.1 to 8.1).

15 REFERENCES

1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

ZYNLONTA (loncastuximab tesirine-lpyl) for injection is a sterile, preservative-free, white to off-white lyophilized powder, which has a cake-like appearance, supplied in a single-dose vial for reconstitution and further dilution. Each carton (NDC 79952-110-01) contains one 10 mg single-dose vial.

Storage and Handling

Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not use beyond the expiration date shown on the carton. Do not freeze. Do not shake.

Special Handling

ZYNLONTA is a hazardous drug. Follow applicable special handling and disposal procedures.1

Any unused drug product or waste material should be disposed in accordance with local requirements.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

  • Effusion and Edema: Advise patients to contact their healthcare provider if they experience swelling, weight gain, shortness of breath, or difficult, labored breathing [see Warnings and Precautions (5.1)].
  • Myelosuppression: Advise patients to immediately contact their healthcare provider for a fever of 100.4°F (38°C) or greater, or signs or symptoms of bruising or bleeding. Advise patients of the need for periodic monitoring of blood counts [see Warnings and Precautions (5.2)].
  • Infections: Advise patients to contact their healthcare provider for signs or symptoms of infection, including fever, chills, weakness and/or difficulty breathing [see Warnings and Precautions (5.3)].
  • Cutaneous Reactions: Advise patients that skin reaction or rash can occur. Patients should be directed to minimize or avoid exposure to direct natural or artificial sunlight, including sunlight exposure through glass windows. Patients should be instructed to protect skin from exposure to sunlight by wearing sun-protective clothing and/or the use of sunscreen products [see Warnings and Precautions (5.4)].
  • Embryo-Fetal Toxicity:
    Advise pregnant women of the potential risk to a fetus. Advise female patients of reproductive potential to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with ZYNLONTA [see Use in Specific Populations (8.1)].
    Advise women of reproductive potential to use effective contraception during treatment with ZYNLONTA and for 10 months after the last dose.
    Advise male patients with female partners of reproductive potential, to use effective contraception during treatment with ZYNLONTA and for 7 months after the last dose [see Warnings and Precautions (5.5) and Use in Specific Populations (8.1), (8.3)].

Manufactured by:
ADC Therapeutics SA
Route de la Corniche 3B
1066 Epalinges, Switzerland
U.S. license No. 2166

Distributed by:
ADC Therapeutics America
Murray Hill, New Jersey 07974

For more information, go to www.ZYNLONTA.com or call 1-855-690-0340

ZYNLONTA is a registered trademark of ADC Therapeutics SA PAB is a registered trademark of B. Braun Medical Inc.

PATIENT INFORMATION ZYNLONTA® (zin lon’ tah) (loncastuximab tesirine-lpyl) for injection, for intravenous use
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: OCT 2022
What is ZYNLONTA? ZYNLONTA is a prescription medicine used to treat adults with certain types of large B-cell lymphoma that has come back (relapsed) or that did not respond to previous treatment (refractory), who have already received two or more treatments for their cancer. It is not known if ZYNLONTA is safe and effective in children.
Before you receive ZYNLONTA, tell your healthcare provider about all of your medical conditions, including if you:
  • have an active infection or have had one recently.
  • have liver problems.
  • are pregnant or plan to become pregnant. ZYNLONTA can harm your unborn baby.Females who can become pregnant:
    • Your healthcare provider may do a pregnancy test before starting treatment with ZYNLONTA.
    • You should use effective birth control (contraception) during treatment with ZYNLONTA and for 10 months after the last dose of ZYNLONTA. Talk to your healthcare provider about effective birth control. Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with ZYNLONTA.
    Males with female partners who can become pregnant:
    • You should use effective birth control (contraception) during treatment with ZYNLONTA and for 7 months after the last dose of ZYNLONTA.
  • are breastfeeding or plan to breastfeed. It is not known if ZYNLONTA passes into breast milk. Do not breastfeed during treatment with ZYNLONTA and for 3 months after the last dose of ZYNLONTA.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get new medicine.
How will I receive ZYNLONTA?
  • ZYNLONTA is given to you by your healthcare provider as an intravenous (IV) infusion into your vein over 30 minutes.
  • ZYNLONTA is usually given every 3 weeks.
  • Your healthcare provider may give you medicine before each infusion to decrease your chance of side effects.
  • Your healthcare provider may stop your treatment, delay your treatment, or change your dose of ZYNLONTA if you have severe side effects.
  • Your healthcare provider should do blood tests regularly to check for side effects of ZYNLONTA.
  • Your healthcare provider will decide how many treatments you need.

What should I avoid while receiving ZYNLONTA? Avoid or limit your exposure to sunlight, including sunlight through glass, such as buildings or vehicle windows and artificial sunlight such as sunlamps or tanning beds. Exposure to sunlight during treatment with ZYNLONTA can cause skin reaction or rash. Use sun protection measures such as sunscreen and wear loose-fitting clothes that cover your skin while out in sunlight.

What are the possible side effects of ZYNLONTA? ZYNLONTA may cause serious side effects, including:
  • Fluid retention. Your body may hold too much fluid during treatment with ZYNLONTA. This can be serious. Tell your healthcare provider if you develop new or worsening swelling or puffiness, weight gain, chest pain, shortness of breath, or trouble breathing.
  • Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with ZYNLONTA but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with ZYNLONTA. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
  • Infections. Serious infections, including infections that can cause death, have happened in people treated with ZYNLONTA. Tell your healthcare provider right away if you have new or worsening signs or symptoms of infection, including:
  • fever
  • chills
  • flu-like symptoms (cough, tiredness or weakness, and body aches)
  • headache
  • breathing problems
  • cuts or scrapes that are red, warm, swollen or painful
  • Skin Reactions. Serious skin reactions have happened in people treated with ZYNLONTA. Tell your healthcare provider if you get new or worsening skin reactions, including sensitivity to sunlight, skin rash, peeling, redness or irritation. You may burn more easily or get severe sunburns. See What should I avoid while receiving ZYNLONTA?
The most common side effects of ZYNLONTA include:
  • feeling tired or weak
  • skin rash
  • swelling
  • nausea
  • muscle or joint pain
  • increase in blood sugar (hyperglycemia)
  • changes in certain blood or laboratory tests
ZYNLONTA may cause fertility problems in males which may affect your ability to father children. Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of ZYNLONTA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of ZYNLONTA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about ZYNLONTA that is written for healthcare professionals.
What are the ingredients in ZYNLONTA?
Active ingredient: loncastuximab tesirine-lpylInactive ingredients: L-histidine, L-histidine monohydrochloride, polysorbate 20, and sucrose.
Manufactured by: ADC Therapeutics SA, Route de la Corniche 3B, 1066 Epalinges, Switzerland U.S. license number 2166
Distributed by: ADC Therapeutics America, Murray Hill, New Jersey 07974
ZYNLONTA is a registered trademark of ADC Therapeutics SA
For more information, go to www.ZYNLONTA.com or call 1-855-690-0340

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