Cellectar Biosciences Announces European Medicines Agency (EMA) Confirms Eligibility to File for Conditional Marketing Authorization (CMA) for Iopofosine I 131 as a Treatment for Refractory (post-BTKi) Waldenstrom Macroglobulinemia (WM)
Cellectar Biosciences (NASDAQ: CLRB) announced that the EMA's Scientific Advice Working Party advised iopofosine I 131 meets eligibility requirements for a Conditional Marketing Authorization (CMA) filing in post-BTKi refractory Waldenstrom macroglobulinemia (WM). A CMA submission is expected in early 2026, with potential European approval and commercial launch across the EMA's 30 countries in 2027. Clinical data include a CLOVER WaM Phase 2 overall response rate of 83.6% and major response rate of 58.2%. Iopofosine holds PRIME designation from EMA and multiple FDA designations; the U.S. NDA depends on funding and a confirmatory trial.
Cellectar Biosciences (NASDAQ: CLRB) ha comunicato che il Working Party sul Consiglio Scientifico dell'EMA ha indicato che iopofosine I-131 soddisfa i requisiti di idoneità per una presentazione di Autorizzazione all'immissione in commercio condizionata (CMA) nel Waldenström macroglobulinemia refrattaria post-BTKi (WM). Si prevede una sottomissione CMA entro all'inizio del 2026, con possibile approvazione europea e lancio commerciale in tutti i 30 paesi dell'EMA nel 2027. I dati clinici includono un tasso di risposta globale di fase 2 di 83,6% e un tasso di risposta maggiore di 58,2% nel programma CLOVER WaM. Iopofosine detiene la designazione PRIME dall'EMA e molte designazioni FDA; l'NDA statunitense dipende dal finanziamento e da uno studio di conferma.
Cellectar Biosciences (NASDAQ: CLRB) anunció que el Grupo de Trabajo de Asesoramiento Científico de la EMA indicó que iopofosina I-131 cumple los requisitos de elegibilidad para una presentación de Autorización de Comercialización Condicionada (CMA) en Waldenströms macroglobulinemia refractaria pos-BTKi (WM). Se espera una solicitud CMA para principios de 2026, con posible aprobación europea y lanzamiento comercial en los 30 países de la EMA en 2027. Los datos clínicos incluyen una tasa de respuesta global de fase 2 de 83,6% y una tasa de respuesta mayor de 58,2% en el programa CLOVER WaM. Iopofosine tiene la designación PRIME de la EMA y varias designaciones de la FDA; la NDA de EE. UU. depende de la financiación y de un ensayo confirmatorio.
Cellectar Biosciences (NASDAQ: CLRB) 는 EMA의 Scientific Advice Working Party가 iopofosine I-131이 적격성 요건을 충족하여 포스트-BTKi 불응성 Waldenström 마이크로글로불루미아(WM)에서 조건부 시장 승인(CMA) 제출에 부합한다고 권고했다고 발표했습니다. CMA 제출은 2026년 초에 예상되며, EMA의 30개국에서 2027년에 유럽 승인 및 상용 출시 가능성이 있습니다. 임상 데이터에는 CLOVER WaM 2상 전체 반응률 83,6%, 주요 반응률 58,2%이 포함됩니다. iopofosine은 EMA의 PRIME 프로그램 지정을 받았으며 여러 FDA 지정도 있습니다; 미국 NDA는 자금 조달 및 확인 시험에 따라 달라집니다.
Cellectar Biosciences (NASDAQ: CLRB) a annoncé que le Groupe d'avis scientifique de l'EMA a indiqué que l'iopofosine I-131 satisfait les exigences d'éligibilité pour un dépôt de mise sur le marché conditionnelle (CMA) dans la Waldenström macroglobulinémie réfractaire post-BTKi (WM). Une soumission CMA est attendue au début de 2026, avec une éventuelle approbation européenne et un lancement commercial dans les 30 pays de l'EMA en 2027. Les données cliniques incluent un taux de réponse globale de phase 2 de 83,6% et un taux de réponse majeure de 58,2% dans le programme CLOVER WaM. L'iopofosine bénéficie de la désignation PRIME de l'EMA et de multiples désignations de la FDA; le NDA américain dépend du financement et d'un essai de confirmation.
Cellectar Biosciences (NASDAQ: CLRB) gab bekannt, dass der Scientific Advice Working Party der EMA empfohlen hat, dass Iopofosine I-131 die Zulässigkeitsanforderungen für eine Einreichung einer Bedingten Marktzulassung (CMA) bei der post-BTKi refraktären Waldenström-Makroglobulämie (WM) erfüllt. Eine CMA-Einreichung wird voraussichtlich im Frühjahr 2026 erfolgen, mit möglicher europäischer Zulassung und Markteinführung in den 30 EMA-Ländern im Jahr 2027. Klinische Daten umfassen eine ORR der Phase 2 von 83,6% und eine Major-Response-Rate von 58,2% im CLOVER WaM-Programm. Iopofosine hält die EMA-PRIME-Z designation sowie mehrere FDA-Deklarationen; der US-NDA hängt von der Finanzierung und einer bestätigenden Studie ab.
Cellectar Biosciences (NASDAQ: CLRB) أعلنت أن مجموعة العمل المعنية بالنصائح العلمية في EMA أوصت بأن iopofosine I-131 يفي بمتطلبات الأهلية لتقديم ترخيص تسويق مشروط (CMA) في مرض Waldenström macroglobulinemia المصاحب بعد BTKi (WM) الذي يعاني من عجز علاجي. من المتوقع تقديم CMA في أواخر 2026، مع احتمال الموافقة الأوروبية والإطلاق التجاري في 30 دولة تابعة لـ EMA في 2027. البيانات السريرية تشمل معدل الاستجابة الكلي للمرحلة 2 بمقدار 83.6% ومعدل الاستجابة الكبرى بمقدار 58.2% في برنامج CLOVER WaM. يحمل iopofosine معاينة PRIME من EMA وعدة تصنيفات FDA؛ يعتمد NDA الأميركي على التمويل وتجربة تأكيدية.
Cellectar Biosciences (NASDAQ: CLRB) 宣布，EMA 的科学咨询工作组建议 iopofosine I-131 符合 资格 要求，用于在 BTKi 之后不应答的 Waldenström 巨球蛋白血症 (WM) 的 有条件上市许可 (CMA) 申报。CMA 预计在 2026 年初 提交，可能获得欧洲批准并在 EMA 的 30 个国家/地区 于 2027 年 实现商业上市。临床数据包括 CLOVER WaM 第 2 阶段总缓解率 83.6%，主要缓解率 58.2%。iopofosine 拿到 EMA 的 PRIME 指定，以及多项 FDA 指定；美国 NDA 取决于资金和确认性试验的进展。
- Overall response rate 83.6% in CLOVER WaM Phase 2
- Major response rate 58.2% (95% CI 0.42–0.67)
- PRIME designation from EMA for WM
- Potential EU approval and launch in 2027 across 30 countries
- Multiple FDA designations: Breakthrough, Fast Track, Orphan
- U.S. NDA contingent on additional funding and confirmatory trial
- SAWP did not assess sufficiency of safety/efficacy for approval
- CMA is conditional—final approval timing remains uncertain
Insights
EMA advised CMA filing could be acceptable for iopofosine I 131, moving EU approval and launch toward 2027.
Cellectar may obtain a Conditional Marketing Authorization by filing in
Approval and commercial launch depend on regulator assessment of the same dataset, manufacturing information, and safety data; SAWP did not opine on sufficiency of efficacy or safety. Additional dependencies include successful CMA review, maintaining isotope supply agreements, and any post-authorization conditions typical of conditional approvals.
Watch for the formal CMA submission in
Following Scientific Advice and Guidance from Scientific Advice Working Party (SAWP) of EMA, Submission of CMA Application for Iopofosine I 131 as a Treatment for Refractory (post-BTKi) WM Expected in Early 2026
Potential 2027 European Approval and Commercial Launch of Iopofosine I 131 as a Treatment for Refractory (post-BTKi) WM
FLORHAM PARK, N.J., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that after a scientific advice procedure, the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA) advised that filing for a Conditional Marketing Authorization (CMA) for iopofosine I 131 as a treatment for post-Bruton Tyrosine Kinase inhibitor (BTKi) refractory patients with Waldenstrom macroglobulinemia (WM) could be acceptable for a CMA. If approved, iopofosine I 131 could be commercially available in the 30 countries represented by the EMA in 2027.
Iopofosine I 131 is Cellectar’s potential first-in-class, novel cancer targeting agent utilizing the company’s proprietary phospholipid ether as a radioconjugate monotherapy, for the treatment of WM for post-Bruton Tyrosine Kinase inhibitor (BTKi) refractory patients. Iopofosine I 131 has been granted PRIME designation from the EMA for the treatment of patients with WM who received at least two prior lines of therapy. WM is a B-cell malignancy characterized by bone marrow infiltration with clonal lymphoplasmacytic cells that produce a monoclonal immunoglobulin M (IgM) that remains incurable with available treatments.
The Company’s decision to file for CMA in Europe follows SAWP’s advice on the patient population for which iopofosine I 131 is acceptable for a CMA, particularly a discussion on a post-BTKi patient population, consistent with the majority of the patients (>
“We are thrilled to take this important step toward bringing iopofosine I 131 to patients in Europe living with WM. With PRIME designation already in hand and feedback from the SAWP, we are rapidly proceeding toward a potential European approval and commercial availability in 2027,” stated James Caruso, president and CEO of Cellectar. “We believe this regulatory success is substantial as it further supports Cellectar’s plans to pursue worldwide approval, including a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) under an accelerated approval pathway, and today’s milestone brings us closer to making that a reality. While submission and conditional approval of an NDA is contingent upon the company obtaining additional funding to support the U.S. confirmatory study initiation, iopofosine I 131 may be approved and commercialized in the EU prior to the initiation of a confirmatory study.”
The CLOVER WaM study (NCT02952508) results demonstrated an overall response rate (ORR) of
“Our planned submission for CMA in Europe represents a significant milestone—not only for patients, but also for our global strategy. Iopofosine I 131 offers a highly attractive profile for potential partners, with compelling patient outcomes, convenient fixed dosing, “off-the-shelf” supply that supports scalable access across geographies, and multiple long-term isotope supply agreements to provide nearly uninterrupted supply. Combined with orphan drug pricing and PRIME designation, we believe this program presents a substantial market opportunity and a clear path to value creation through regional and global collaborations,” said Jarrod Longcor, chief operating officer of Cellectar.
The U.S. NDA will be submitted once the confirmatory trial is underway and will be supported by data from the Phase 2b CLOVER WaM clinical trial that demonstrated a statistically significant major response rate compared to a null hypothesis of
The U.S. FDA has granted iopofosine I 131 Breakthrough Therapy, Fast Track and Orphan Drug Designations for the treatment of r/r WM.
About Conditional Market Authorization
Conditional Marketing Authorization (CMA) is a regulatory pathway offered by EU legislation that enables earlier access to medicines that address unmet medical needs, particularly in serious or life-threatening conditions. CMA allows for approval based on less comprehensive clinical data than normally required, provided the benefit of the immediate availability on the market of the relevant medicinal product outweighs the risk that additional data are still required and the applicant is likely to be able to provide comprehensive data.
About Scientific Advice Working Party
The Scientific Advice Working Party (SAWP) is a standing working party within the EMA with the sole remit of providing scientific advice and protocol assistance. It was established by the Committee for Medicinal Products for Human Use (CHMP).
The SAWP is a multidisciplinary group, which comprises a chairperson, 36 members including three members of the Committee for Orphan Medicinal Products (COMP), three members of the Paediatric Committee (PDCO), three members of the Committee for Advanced Therapies (CAT) and one member of the Pharmacovigilance Risk Assessment Committee (PRAC).
About PRIME Designation
The European Medicines Agency’s (EMA) PRIME (PRIority MEdicines) designation is a regulatory initiative designed to enhance support for the development of medicines that target unmet medical needs. PRIME provides early and proactive engagement with developers to optimize clinical development plans and accelerate regulatory review, helping promising therapies reach patients sooner. Products granted PRIME status benefit from enhanced scientific advice, dedicated EMA support, and eligibility for accelerated assessment at the time of marketing authorization application.
About Waldenstrom’s Macroglobulinemia
Waldenstrom’s Macroglobulinemia (WM) is a B-cell malignancy characterized by bone marrow infiltration with clonal lymphoplasmacytic cells that produce a monoclonal immunoglobulin M (IgM) that remains incurable with available treatments. The prevalence in the US is approximately 26,000 with 1,500–1,900 patients being diagnosed annually. Approximately 11,500 patients require treatment in the relapsed or refractory setting and there are an estimated 4,700 patients requiring third line or greater therapy. There are also approximately 1,000 patients that have exhausted all current treatment options by third line because they are ineligible or intolerant to those existing therapies. Therefore, the total addressable market for third line or greater therapy is approximately 5,700 patients. There are no U.S. Food and Drug Administration (FDA) approved treatment options for patients progressing on BTKi therapy. BTKi therapies do not demonstrate complete response rates and require continuous treatment.
Non-FDA approved treatments are used in more than
About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects.
The company’s product pipeline includes its lead assets: iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope); CLR 121225, an actinium-225 based program being targeted to several solid tumors with significant unmet need, such as pancreatic cancer; and CLR 121125, an iodine-125 Auger-emitting program targeted in other solid tumors, such as triple negative breast, lung and colorectal, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.
In addition, iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, and the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has also granted iopofosine I 131 six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications.
For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook.
Forward Looking Statements Disclaimer
This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the FDA and EMA regulatory pathways, ability to execute strategic alternatives, identify suitable collaborators, partners, licensees or purchasers for our product candidates and, if we are able to do so, to enter into binding agreements with regard to any of the foregoing, or to raise additional capital to support our operations, or our ability to fund our operations if we are unsuccessful with any of the foregoing. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2024, and our Form 10-Q for the quarterly period ending June 30, 2025. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.
INVESTORS:
Anne Marie Fields
Precision AQ
212-362-1200
annemarie.fields@precisionaq.com
FAQ
When does Cellectar plan to file the CMA for iopofosine I 131 (CLRB)?
What is the projected European commercial launch date for CLRB's iopofosine I 131?
What clinical efficacy did CLOVER WaM report for CLRB's iopofosine I 131?
Does EMA support Cellectar's CMA submission eligibility for iopofosine I 131 (CLRB)?
Will CLRB submit a U.S. NDA for iopofosine I 131 before or after the confirmatory trial?
How many European WM patients could be affected by CLRB's iopofosine I 131?
