BLENREP is a prescription medicine used to treat multiple myeloma in adults whose cancer has come back or did not respond to prior treatment and who have already received at least 4 prior therapies, including at least 1 therapy from each of these classes of drugs:
- An immunomodulatory agent, for example:
- Revlimid (lenalidomide)
- Pomalyst (pomalidomide)
- Thalomid (thalidomide)
- A proteasome inhibitor, for example:
- Velcade (bortezomib)
- Kyprolis (carfilzomib)
- Ninlaro (ixazomib)
- An anti-CD38 monoclonal antibody, for example:
- Darzalex (daratumumab)
Ask your healthcare provider to ensure you have received at least 1 of each of these treatments.
BLENREP is approved based on patient response rate. Studies are ongoing to confirm the clinical benefit of BLENREP for this use.
What is an antibody-drug conjugate (ADC)?
An ADC is made of a cell-killing medication attached to an antibody.* The antibody of BLENREP seeks out and targets BCMA, a protein found on the surface of multiple myeloma cells in all patients. The linked drug can then enter and kill multiple myeloma cells from the inside or activate your immune system to fight your cancer.
*An antibody is a type of protein produced by the immune system in response to a foreign substance. Sometimes treatments can use antibodies to help fight cancer.
BLENREP is the first and only ADC that targets BCMA, commonly seen on myeloma cells
It is possible that healthy cells may also be affected.
BCMA is a protein found on the surface of myeloma cells in all patients with multiple myeloma. BCMA is found on healthy plasma cells and cancerous myeloma cells alike and:
- helps fuel cell growth
- protects cells from dying
BCMA is found at higher levels on myeloma cells.
BCMA is shared by all multiple myeloma patients
BLENREP works in different ways to help your body fight multiple myeloma:
BLENREP identifies cells that express BCMA, such as cancerous myeloma cells, and attaches directly to the BCMA protein. BLENREP is brought into the cancerous myeloma cells, releasing medication resulting in cell death.*
*It is possible that healthy cells will be affected.
Once BLENREP attaches, the antibody part of the antibody-drug conjugate attracts your body’s own immune system to recognize the cancerous myeloma cells and attack them.
BLENREP, an option after relapse, works in different ways, including using your body's own immune system.
Two doses of BLENREP were evaluated (studied) in patients with relapsed or refractory multiple myeloma. The results below only include the 97 patients who received the recommended dose of BLENREP. About a quarter of these patients had high-risk cytogenetics [presence of t(4;14), t(14;16), or 17p13del mutations].
These patients had received prior treatment for multiple myeloma, including an anti-CD38 antibody, and were no longer responding to an immunomodulatory agent and to a proteasome inhibitor.
Response was seen in patients whose cancer had returned or progressed multiple times. Patients in the trial had received at least 3 and up to 21 prior treatment regimens. Half the patients had received 7 or fewer treatments.
IN PATIENTS WHO RESPONDED:
- BLENREP worked in about 6 weeks
- BLENREP response lasted at least 6 months for most patients (73%)
- BLENREP showed a very good partial response or better in 60% of patients (18 out of 30 patients)
In the 97 patients evaluated, 2 patients (2%) had a stringent complete response, 1 (1%) had a complete response, 15 (15%) had a very good partial response, and 12 (12%) had a partial response. These categories describe how well a patient responded to BLENREP.
The most common side effects (≥20%) seen in patients who received the recommended dose of BLENREP were vision or eye changes such as findings on an eye exam (keratopathy*), decreased vision or blurred vision, nausea, low blood cell counts, fever, infusion-related reactions, tiredness, and changes in kidney or liver function blood tests
*Changes to the surface of your eye found during an eye exam, with or without symptoms, are considered keratopathy.
These are not all the possible side effects of BLENREP.
Of all the side effects, some led to treatment interruption, dose reduction, and treatment discontinuation:
- 54% of patients experienced a treatment interruption. Side effects that led to an interruption in more than 3% of patients included keratopathy (47%), blurred vision (5%), dry eye (3.2%), and pneumonia (3.2%).
- 29% of patients experienced a dose reduction. Side effects that led to dose reduction in more than 3% of patients included keratopathy (23%) and decreased platelets (5%).
- 8% of patients discontinued treatment permanently. This was most commonly due to keratopathy (2.1%).
- Eye problems reported in patients who received the recommended dose of BLENREP included keratopathy (71%), decreased vision (53%), blurred vision (22%), and dry eye (14%).
Eye problems, which can be serious, were common with BLENREP. In 218 patients who received 2 different doses, the following were seen:
- Eye problems occurred in 77% of all 218 patients in the clinical trial. These included keratopathy (76%), decreased vision (55%), blurred vision (27%), and dry eye (19%).
- Among 165 patients who had keratopathy, 49% had eye symptoms, 65% had a clinically significant change in vision, and 34% had both eye symptoms and changes in vision.
- Of 149 patients with moderate to severe keratopathy, 39% recovered to mild findings or better after a follow-up of approximately 6 months, and the median time to resolution was 2 months (range: 11 days to 8.3 months).
- Of the 61% who had ongoing keratopathy, 28% were still on treatment, 9% were in follow-up, and in 24% the follow-up ended due to stopping participation, being lost to follow-up, or death.
- Of 41 patients who experienced decreased vision of worse than 20/40, 88% resolved, and the median time to resolution was 22 days (range: 7 days to 4.2 months).
- Of 3 patients who experienced decreased vision of 20/200 or worse, all resolved, and the median duration was 22 days (range: 15 to 22 days).
Because of the risk of eye problems, BLENREP is only available through a restricted program called the BLENREP REMS.
If you experience any side effects while taking BLENREP, please contact your healthcare provider.
Treatment infusions can be administered
Your healthcare provider may decrease your dose or temporarily stop or completely stop treatment with BLENREP if you have serious side effects.
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
Tell your healthcare provider about all your medical conditions, including if you:
- Have a history of vision or eye problems
- Have bleeding problems or a history of bleeding problems
- Are pregnant or plan to become pregnant. BLENREP can harm your unborn baby
- Are breastfeeding or plan to breastfeed. It is not known if BLENREP passes into your breast milk
Tell your healthcare provider about all the medications you take, including:
- Prescription and over-the-counter medicines
- Vitamins and herbal supplements
Review your REMS patient guide prior to your first infusion
You will need to receive important exams:
- Eye exam: Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with BLENREP
- Pregnancy test: Your healthcare provider may do a pregnancy test before you start treatment, as BLENREP may harm your unborn baby
- Blood cell counts
If you experience any sIde effects whIle takIng BLENREP, it is Important to contact your healthcare provIder
Monitor and tell your healthcare provider if you have any symptoms and side effects
- Tell your healthcare provider if you have any vision changes or eye problems during treatment with BLENREP
- Tell your healthcare provider if you have bleeding or bruising during treatment with BLENREP
- Tell your healthcare provider or nurse right away if you get any of the following signs or symptoms of an infusion reaction while receiving BLENREP:
- chills or shaking
- redness of your face (flushing)
- itching or rash
- shortness of breath, cough, or wheezing
- swelling of your lips, tongue, throat, or face
- feel like passing out
- feel like your heart is racing (palpitations)
Eye care is important
- You will receive an eye exam prior to each dose of BLENREP and for worsening symptoms of eye problems as required by the BLENREP REMS. Eye exams are important, as some changes can happen without symptoms and may only be seen on an eye exam
- Use preservative-free lubricant eye drops 4 times each day throughout your treatment with BLENREP as instructed by your healthcare provider. Guidance on using eye drops is provided here.
- Don’t wear contact lenses, unless your doctor advises you to. If you normally wear contact lenses, you can plan to use a pair of eyeglasses while taking BLENREP
- Use caution when driving or operating machinery
- It is important for patients who are able to become pregnant, and males with female partners who are able to become pregnant, to use effective contraception. Talk to your healthcare provider about birth control methods you can use during this time
- Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with BLENREP
- Do not breastfeed during treatment with BLENREP and for at least 3 months after the last dose
Talk to your healthcare provider before stopping your contraception
- Males with female partners who are able to become pregnant should use effective contraception for at least 6 months after the last dose of BLENREP
- Patients who are able to become pregnant should continue to use effective contraception for at least 4 months after the last dose of BLENREP