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FDA Grants Priority Review to Regeneron’s Linvoseltamab for Multiple Myeloma

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The Food and Drug Administration (FDA) has bestowed Priority Review status upon Regeneron Pharmaceuticals’ biologics license application (BLA) for linvoseltamab, intended to address relapsed/refractory multiple myeloma in adults who have undergone disease progression following at least three prior therapies. Linvoseltamab, a groundbreaking bispecific antibody, represents a significant advancement in the treatment landscape for multiple myeloma. Engineered to target B-cell maturation antigen (BCMA) present on the surface of multiple myeloma cells, linvoseltamab utilizes a unique mechanism of action by engaging CD3-expressing T cells. This interaction triggers the activation of T cells, empowering them to recognize and eliminate cancerous cells within the body.

The innovative approach of linvoseltamab holds considerable promise for patients grappling with relapsed/refractory multiple myeloma, offering a novel therapeutic avenue to combat the disease’s progression. The robust clinical data supporting linvoseltamab’s efficacy and safety profile have led to its progression through regulatory channels, culminating in the submission of a biologics license application to the Food and Drug Administration.

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In recognition of the critical need for effective therapies in the fight against multiple myeloma, the FDA has bestowed the priority review process for linvoseltamab. This designation, known as Priority Review, accelerates the assessment of the BLA, aiming to expedite the availability of this potential treatment option to patients in need. The Prescription Drug User Fee Act (PDUFA) action date of August 22, 2024, has been established, signifying the target date by which the FDA aims to complete its review and make a decision regarding the approval of linvoseltamab.

Linvoseltamab received Priority Review status with the Potential to Transform Multiple Myeloma Care

The anticipation surrounding linvoseltamab’s regulatory journey underscores the significant unmet medical need in the management of relapsed/refractory multiple myeloma. With limited treatment options available, particularly for patients who have experienced disease progression following multiple lines of therapy, linvoseltamab represents a beacon of hope in providing renewed optimism and improved outcomes for these individuals.

As the BLA submission undergoes rigorous evaluation by regulatory authorities, stakeholders in the medical and scientific communities eagerly await the outcome, recognizing the transformative potential of linvoseltamab in reshaping the treatment paradigm for multiple myeloma. The forthcoming decision as a result of the Priority Review by the FDA will not only impact the availability of this innovative therapy but also hold implications for the broader landscape of oncology care, reaffirming the commitment to advancing precision medicine approaches to address complex and challenging diseases.

An estimated 35,000 individuals in the United States are diagnosed with multiple myeloma annually. While significant strides have been made in treating this disease, it remains incurable. Current therapies can delay disease progression; however, most patients eventually necessitate additional treatments.

The FDA’s decision to grant Priority Review was based on data from the ongoing LINKER-MM1 trial (NCT03761108), a Phase I/II study involving 282 patients with relapsed/refractory multiple myeloma. The Phase I segment of LINKER-MM1 focused on assessing linvoseltamab’s safety, tolerability, and dose-limiting toxicities across various dosing levels and regimens. Phase II of the trial has an objective response rate as its primary endpoint, with secondary endpoints including duration of response, progression-free survival, minimal residual disease negativity rate, and overall survival.

Priority Review

Pioneering Advances in Multiple Myeloma Treatment Through Clinical Trials

Eligible patients for enrollment in the trial include those with triple-class refractory multiple myeloma or those who have received three or more prior lines of therapy. The treatment regimen involves an initial step-up dosing of linvoseltamab followed by full-dose administration. Investigators are also exploring a response-adapted approach, allowing patients to achieve a very good partial response or complete response after 24 weeks of treatment to transition to a less frequent dosing schedule.

At a median follow-up of 11 months, the latest data from the trial revealed that 71% of patients treated with 200 mg linvoseltamab achieved an objective response, with a complete response rate or better observed in 46% of patients.

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Additionally, linvoseltamab is being evaluated in the Phase III LINKER-MM3 trial (NCT05730036), comparing the agent with elotuzumab, pomalidomide, and dexamethasone. Other ongoing or planned trials include LINKER-MM4 among treatment-naive patients, LINKER-SMM1 among those with high-risk, smoldering multiple myeloma, and LINKER-MGUS1 among individuals with high-risk monoclonal gammopathy of undetermined significance.

It is important to note that as linvoseltamab is still in clinical development, its safety and efficacy have not yet been fully evaluated by any regulatory authority.

 

Resource: Pharmexec, February 21, 2024


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