Blenrep assigned permanent billing code, supporting timely access for patients with relapsed/refractory multiple myeloma

• Blenrep permanent J-code (J9053) becomes effective July 1.

GSK plc (LSE/NYSE: GSK) today announced that Blenrep (belantamab mafodotin-blmf) has been assigned a permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9053) by the Centers for Medicare & Medicaid Services (CMS), effective July 1, 2026. For adults living with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent, a standardized billing pathway for Blenrep may help facilitate access and support timely treatment.

The assignment of a permanent J code supports consistent coding and billing for Blenrep in clinical practice, helping to streamline reimbursement processes for healthcare providers treating patients with multiple myeloma. 

This is particularly meaningful in community oncology settings, where approximately 70% of multiple myeloma patients receive care, and where timely access to treatment can be directly impacted by reimbursement clarity and practice efficiency.¹

Patrick Connor, Head of US Oncology, GSK said: “Patients with multiple myeloma often endure an ongoing cycle of relapse and remission. Having effective therapies that help them stay in remission and live longer is critical – and so is timely access without delays due to billing and reimbursement complexity. We now have a clear, consistent reimbursement pathway – removing administrative barriers and enabling the right patients to access treatment faster.”

Blenrep was approved by the US Food and Drug Administration in October 2025 in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.  Blenrep is a community-ready anti-BCMA agent that can be administered in REMS-certified outpatient settings, fulfilling a major patient need.

Dr. Joseph Mikhael, Director of Myeloma Research at the HonorHealth Research Institute and Medical Advisor, International Myeloma Foundation, said: “The majority of patients with multiple myeloma receive care close to home – in community settings – where clarity and predictability in reimbursement are essential to delivering timely care. A permanent J code improves reimbursement processes and reduces administrative burden, so providers can stay focused on patients and patients can stay focused on their treatment.”

GSK also offers Together with GSK, an optional patient support program available to all US patients prescribed Blenrep. Designed to assist both patients and healthcare providers, the program offers personalized help navigating insurance, addressing cost concerns, and offering ongoing education and support. Learn more at TogetherwithGSK.com. 

About multiple myeloma

Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.^2,3  There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.⁴ Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.⁵ Many patients with multiple myeloma, including approximately 70% in the US, are treated in a community cancer setting, leaving a need for new, effective therapies with manageable side effects that can be administered outside of an academic center.^1,6,7

About Blenrep (belantamab mafodotin-blmf)

Blenrep is a monoclonal ADC (antibody-drug conjugate) comprising a humanized BCMA (B-cell maturation antigen) conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Indication and Important Safety Information for BLENREP (belantamab mafodotin-blmf)

BLENREP is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

IMPORTANT SAFETY INFORMATION

WARNING: OCULAR TOXICITY BLENREP causes changes in the corneal epithelium resulting in changes in vision, including severe visual impairment, and symptoms such as blurred vision and dry eyes. In the clinical study, corneal ulcers, including cases with infection, also occurred. Conduct ophthalmic exams at baseline, before each dose, promptly for new or worsening symptoms, and as clinically indicated. In the clinical study, 83% of patients required a dosage modification due to ocular toxicity. Withhold BLENREP until improvement and resume or permanently discontinue, based on severity. Because of the risk of ocular toxicity, BLENREP is available only through a restricted program called the BLENREP Risk Evaluation and Mitigation Strategy (REMS).

WARNINGS AND PRECAUTIONS

Ocular Toxicity

BLENREP causes ocular toxicity, defined as changes in the corneal epithelium and changes in BCVA based on ophthalmic exam (including slit lamp exam), or other ocular adverse reactions as defined by the CTCAE.

In DREAMM-7, ocular toxicity occurred in 92% of patients, including Grade 3 or 4 in 77% of patients. The most common ocular toxicities (>25%) were reduction in BCVA (89%) and corneal exam findings (86%) based on ophthalmic exam findings, blurred vision (66%), dry eye (51%), photophobia (47%), foreign body sensation in eyes (44%), eye irritation (43%), and eye pain (33%).

Ocular toxicity based on ophthalmic exam findings was reported as Grade 2 in 9% of patients, Grade 3 in 56% of patients, and Grade 4 in 21% of patients. The median time to onset of the first Grade 2 to 4 ophthalmic exam findings was 43 days (range: 15 to 611 days). The median duration of all Grade 2 to 4 ophthalmic exam findings was 85 days (range: 5 to 813 days). Patients experienced a median of 3 episodes (range: 1 to 11 episodes) of ocular toxicity based on ophthalmic exam findings. Of the patients with Grade 2 to 4 ophthalmic exam findings, 42% had improvement of the last event to Grade 1 or better; 22% had resolution of the last event based on return to baseline or normal ophthalmic exam findings. 

The most commonly reported corneal exam findings included superficial punctate keratopathy, microcyst-like deposits, epithelial changes, and haze. Cases of corneal ulcer, including cases with infection, have been reported and should be managed promptly by an eye care professional.

A reduction in BCVA to 20/50 or worse in at least one eye occurred in 69% of patients, including 29% who experienced a change in BCVA to 20/100 or worse, and 12% who experienced a change in BCVA to 20/200 or worse. Of the patients with reduced BCVA to 20/50 or worse in at least one eye, 61% had resolution of the last event to baseline or better. Of the patients with reduced BCVA to 20/100 or worse, 57% had resolution of the last event. Of the patients with reduced BCVA to 20/200 or worse, 48% had resolution of the last event. 

Ophthalmic exams (including slit lamp exam and BCVA assessment) should be conducted by an eye care professional, such as an ophthalmologist or optometrist, at baseline, before each dose of BLENREP, promptly for new or worsening symptoms, and as clinically indicated. Perform baseline exam within 4 weeks prior to the first dose. Perform each follow-up exam within 10 days prior to the next planned dose. All effort should be made to schedule the exam as close to BLENREP dosing as possible. Withhold BLENREP until improvement in both corneal exam findings and change in BCVA to Grade 1 or less and resume at same or reduced dose or permanently discontinue based on severity.

Counsel patients to promptly inform their healthcare provider of any ocular symptoms. Counsel patients to use preservative-free artificial tears at least 4 times a day starting with the first infusion and continuing until the end of treatment, and to avoid wearing contact lenses for the duration of therapy. Bandage contact lenses may be used under the direction of an eye care professional.

Changes in visual acuity may be associated with difficulty for driving and reading. Counsel patients to use caution when driving or operating machinery.

BLENREP Risk Evaluation and Mitigation Strategy (REMS)

BLENREP is available only through a restricted program called the BLENREP REMS because of the risk of ocular toxicity. 

Further information is available at www.BLENREPREMS.com and 1 855 690-9572. 

Thrombocytopenia

Thrombocytopenia of any grade occurred in 100% of patients in DREAMM 7. 
Grade 2 thrombocytopenia occurred in 10% of patients, Grade 3 in 29% of patients, and Grade 4 in 45% of patients. Clinically significant bleeding (Grade ≥2) occurred in 7% of patients with concomitant low platelet levels (Grade 3 or 4).

Monitor complete blood cell counts at baseline and periodically during treatment as clinically indicated. Withhold or reduce the dose of BLENREP based on severity. 

Embryo fetal Toxicity 

Based on its mechanism of action, BLENREP can cause fetal harm when administered to a pregnant woman because it contains a genotoxic compound (the microtubule inhibitor, monomethyl auristatin F [MMAF]) and it targets actively dividing cells.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BLENREP and for 4 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose. 

ADVERSE REACTIONS

The most common adverse reactions (≥20%) with BLENREP in combination with bortezomib and dexamethasone are reduction in BCVA, corneal exam findings, blurred vision, dry eye, photophobia, foreign body sensation in eyes, eye irritation, upper respiratory tract infection, hepatotoxicity, eye pain, diarrhea, fatigue, pneumonia, cataract and COVID-19.

The most common Grade 3 or 4 (≥10%) laboratory abnormalities are decreased platelets, decreased lymphocytes, decreased neutrophils, increased gamma-glutamyl transferase, decreased white blood cells, and decreased hemoglobin. 

Please see the full US Prescribing Information, including BOXED WARNING and Medication Guide for BLENREP.

GSK in oncology

Our ambition in oncology is to help increase overall quality of life, maximize survival and change the course of disease, expanding from our current focus on blood and women’s cancers into lung and gastrointestinal cancers, as well as other solid tumors. This includes accelerating priority programs such as antibody-drug conjugates targeting B7-H3 and B7-H4, and IDRX-42, a highly selective KIT tyrosine kinase inhibitor.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at www.us.gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2025, and GSK’s Q1 Results for 2026.