News release: Exciting news for DLBCL Patients: A New Treatment Option Registered!

Exciting News for DLBCL Patients: A New Treatment Option Registered!

On 29th May 2025, Medsafe registered a new treatment combination: Columvi® (glofitamab) plus chemotherapy (GemOx) in New Zealand. This registration means that adults whose diffuse large B-cell lymphoma (DLBCL) has returned or did not respond to initial treatment, and who are not eligible for a stem cell transplant, will have another important treatment option in the future.1

What does "Medsafe registration" mean for you?

Before a new medicine can be made widely available, it undergoes careful review by health experts to ensure it's safe and effective. This registration from Medsafe confirms that glofitamab plus chemotherapy has met these high standards and can now be used to treat eligible NZ patients.

What did the pivotal study show?

This registration is based on the results of a clinical study called STARGLO. This study compared the new treatment combination to a standard treatment of rituximab plus chemotherapy (GemOx) in patients whose DLBCL had relapsed or was not responding to initial therapy and who were not eligible for a stem cell transplant.

The study showed that patients receiving glofitamab plus chemotherapy (GemOx) lived almost twice as long compared with those receiving the standard therapy. Furthermore, more than twice as many patients on the glofitamab combination experienced a complete disappearance of their cancer. The safety of the combination was consistent with what is already known about the individual medicines.2

Why is this important?

DLBCL is a fast-growing cancer, and if it comes back or doesn't respond to the first treatment, it's crucial to have effective options available quickly. This new glofitamab-based treatment offers an "off-the-shelf" option, meaning it can be readily available for patients without the delays associated with more complex treatments. It's also designed as a fixed-duration therapy, offering the possibility of a planned end to the treatment course and a treatment-free period afterwards. This can provide a sense of control and allow patients to plan for the future.

Looking ahead: Making this treatment accessible

We understand that access to new medicines is a significant concern for patients and their families. While we work towards securing Pharmac reimbursement for glofitamab we are actively exploring patient access solutions. Our goal is to ensure that eligible patients can benefit from this innovative treatment as soon as possible. We are committed to working closely with patient advocacy groups and healthcare providers to navigate the reimbursement process and implement effective access programs. We will share more information about this programme as soon as it becomes available.

This registration marks an important step forward in the treatment of relapsed or refractory DLBCL, offering hope for improved outcomes and a better quality of life for patients.

1. Columvi (glofitamab) Data Sheet www.medsafe.govt.nz

2. Abramson JS et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial, Lancet 2024; 404:1940-54

Columvi® (glofitamab), 2.5 mg/2.5 mL and 10 mg/10 mL vial, is a Prescription Medicine used for the treatment of adults with diffuse large B-cell lymphoma (DLBCL). It is used when the cancer has come back (relapsed) or the cancer did not respond to previous treatments.

Ask your doctor if Columvi is right for you.

Columvi is an unfunded medicine

Ask your health professional about the cost of the medicine and other fees that may apply.

Use only as directed. If symptoms continue or you have side effects, see your healthcare professional. For more information about Columvi:

● talk to your health professional; or

● visit medsafe.govt.nz for Columvi Consumer Medicine Information; or

● visit roche.co.nz or call Roche on 0800 276 243.

Columvi has risks and benefits.

Possible common side effects include: Reduced levels in blood tests of: neutrophils or lymphocytes (types of white blood cell), which may cause fever or symptoms of an infection; red blood cells (anaemia), which may cause tiredness, feeling unwell and pale skin; platelets (a type of blood cell), which may cause unusual bruising or bleeding; low levels in blood tests, phosphate, magnesium, calcium or potassium; low sodium levels in blood tests, which may cause tiredness, muscle twitching or cramps; increased levels in blood tests of liver enzymes and bilirubin (yellow substance in blood), which may cause yellowing of skin or eyes, and dark urine; fever; rash; headache; ; new or recurring viral infections, such as lung infection, shingles or cytomeglovirus; bacterial infections, such as urinary tract infection; infection in or around the stomach; respiratory tract infections, such as runny nose, sore throat, sinus infections, and chest colds; lung infection (pneumonia), which may cause fever, cough, and difficulty breathing; infection in blood (sepsis), which may cause fever, chills and confusion; fungal infection; COVID-19 infection caused by a virus called coronavirus (SARS-CoV-2); fever with low levels of neutrophils; ; constipation; diarrhoea; feeling sick (nausea); vomiting; bleeding in the stomach or gut (gastrointestinal haemorrhage), which may cause black stools or blood in vomit; abdominal (belly) pain; inflammation of the large bowel, which may cause abdominal pain, bloody stools and the urge to have a bowel movement; confusion; trembling; sleepiness; pain in muscles or bones; numbness, tingling, a burning sensation, pain, discomfort or weakness and /or difficulty walking (peripheral neuropathy); inflammation of the pancreas.

Do not use Columvi if: you are allergic to glofitamab or any of the ingredients in Columvi.

Tell your doctor if: you have any other medical conditions or take any other medicines.

Pregnancy/lactation: tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.

Tell your doctor immediately or go to your nearest Accident and Emergency Centre if you notice any of the following: Cytokine release syndrome: symptoms include fever, fast heartbeat, feeling dizzy or lightheaded, chills, shortness of breath, fever with low levels of neutrophils (a type of white blood cell)

Neurologic toxicity including ICANS: symptoms include confusion, disorientation, sleepiness, or change in consciousness level Infections: symptoms include fever, chills, difficulty breathing, burning pain when passing urine Tumour flare: symptoms include your cancer appearing to become worse, developing tender swollen lymph nodes, chest pain, cough, inability to breathe easily, or pain at the site of the tumour Tumour lysis syndrome: symptoms include weakness, shortness of breath, feeling confused, irregular heartbeat, muscle cramps.

Panel dated 19 May 2025 All trademarks mentioned herein are protected by law. Roche Products (New Zealand) Limited, Auckland.

M-NZ-00001317/MR11893/MAY2025