Saturday, April 20, 2024

BeiGene’s Brukinsa Secures Pioneering US Approval for Follicular Lymphoma, Expanding Its Therapeutic Reach

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BeiGene’s BTK inhibitor Brukinsa achieves a milestone as it secures US approval for follicular lymphoma (FL), marking the first in its class to receive such recognition in this indication. This regulatory green light grants Brukinsa the broadest label among its competitors, solidifying its position in the market.

The recent accelerated approval granted by the FDA for Brukinsa marks a significant milestone in the treatment landscape for adults grappling with relapsed or refractory follicular lymphoma. This regulatory nod, achieved in combination with Roche’s Gazyva, broadens the therapeutic spectrum of Brukinsa, solidifying its position as a versatile treatment option. FL, characterized by its challenging clinical course, presents a formidable obstacle for patients who have exhausted at least two prior lines of treatment.

BeiGene’s Brukinsa, already established in various hematologic malignancies, now extends its reach into FL, further expanding its repertoire of therapeutic applications. The FDA’s accelerated approval underscores the urgent need for novel treatment modalities in the FL space, where limited options exist for patients facing disease recurrence or refractory disease.

By targeting FL patients who have undergone multiple lines of treatment, Brukinsa offers renewed hope and the potential for improved outcomes in this patient population. The approval represents a testament to the drug’s efficacy and safety profile, as well as its potential to address the unmet needs of FL patients who are in dire need of effective therapeutic interventions.

FDA Approval Expands Brukinsa’s Reach into Follicular Lymphoma, Marking a New Era in Hematologic Treatment

As the fifth indication for Brukinsa, the FDA’s green light underscores the drug’s versatility and its ability to navigate the complexities of diverse hematologic malignancies. This expanded label not only enhances BeiGene’s product portfolio but also reinforces its commitment to advancing innovative therapies for patients across various disease states.

Moving forward, the approval of Brukinsa in FL sets a precedent for future advancements in hematologic oncology, paving the way for continued innovation and progress in the field. With FL being a particularly challenging subtype of non-Hodgkin lymphoma, the availability of Brukinsa offers newfound optimism and therapeutic options for patients and healthcare providers alike.

In conclusion, the FDA’s accelerated approval of Brukinsa in combination with Gazyva represents a significant stride forward in the management of relapsed or refractory FL. This landmark approval not only expands treatment options for patients but also signals a paradigm shift in the approach to managing this complex hematologic malignancy. As research and development efforts continue to evolve, Brukinsa stands as a beacon of hope in the ongoing quest to improve outcomes and quality of life for FL patients worldwide.

Previously cleared by the FDA for mantle cell lymphoma (MCL), Waldenström macroglobulinemia (WM), chronic lymphocytic leukemia (CLL), and marginal zone lymphoma (MZL), Brukinsa’s expanded label in follicular lymphoma distinguishes it from competitors like AbbVie and Johnson & Johnson’s Imbruvica and AstraZeneca’s Calquence.

Follicular Lymphoma

Surging Sales and Clinical Success Position It as a Leader in Follicular Lymphoma Treatment

As BeiGene’s flagship product, Brukinsa’s sales soared to $1.3 billion in the past year, projecting continued robust growth in 2024. Analysts forecast peak sales exceeding $3 billion, potentially rivaling the figures achieved by Imbruvica and Calquence. However, the inclusion of Imbruvica in Medicare price negotiations by 2026 could introduce pricing pressures across the entire class.

The FDA’s approval for follicular lymphoma stems from the positive outcomes of the ROSEWOOD trial, which demonstrated a superior overall response rate (ORR) for the Brukinsa-Gazyva combination compared to Gazyva alone. Notably, 69% of patients exhibited a response lasting at least 18 months, underscoring the therapy’s sustained efficacy.

The drug’s continued presence in the US market for follicular lymphoma hinges on the results of the confirmatory MAHOGANY trial, evaluating Brukinsa and Gazyva against lenalidomide and rituximab in relapsed or refractory follicular lymphoma and marginal zone lymphoma. Progression-free survival (PFS) serves as the trial’s primary endpoint, with interim findings expected before the trial’s conclusion in 2028.

Follicular lymphoma, the second most prevalent type of non-Hodgkin lymphoma, affects approximately 22% of all cases and sees around 15,000 new diagnoses annually in the US. Despite its incurable nature, follicular lymphoma progresses relatively slowly, boasting a five-year survival rate of approximately 90%. However, the disease’s propensity for relapse or inadequate response to treatment underscores the necessity for diverse therapeutic options throughout patients’ disease trajectories.

 

Resource: Pharmaphorum, March 08, 2024

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