Tuesday, June 18, 2024

Cancer Treatment Innovation: FDA Considers Approval of Subcutaneous Immunotherapy Opdivo

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The U.S. Food and Drug Administration (FDA) has announced an updated Prescription Drug User Fee Act (PDUFA) goal date for Bristol Myers Squibb’s Biologics License Application (BLA) concerning subcutaneous nivolumab immunotherapy for melanoma, non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC). This application aims to secure approval for a subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20). The newly set PDUFA goal date is December 29, 2024.

This updated timeline is pivotal for the ongoing development and potential market introduction of this innovative subcutaneous formulation. The subcutaneous version of Opdivo is designed to offer patients a more convenient and less invasive administration option compared to the traditional intravenous method. If approved, it will become the first and only subcutaneously administered PD-1 inhibitor, potentially revolutionizing the treatment landscape for various cancers.

The Biologics License Application for subcutaneous nivolumab is backed by robust clinical data from the CheckMate -67T trial, a Phase 3 study that evaluated its pharmacokinetics, efficacy, and safety. The trial results demonstrated that subcutaneous administration of nivolumab is non-inferior to the intravenous formulation, ensuring that patients receive the same therapeutic benefits with a more patient-friendly delivery method.

Streamlining Cancer Treatment: CheckMate -67T Examines Subcutaneous Opdivo for Kidney Cancer

The CheckMate -67T trial involved 495 patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who had previously received systemic therapy. Participants were randomized to receive either subcutaneous nivolumab or intravenous Opdivo. The primary endpoints included time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady-state (Cminss), while secondary endpoints focused on the objective response rate (ORR).

The development of subcutaneous nivolumab aligns with Bristol Myers Squibb’s commitment to enhancing patient care and convenience. By offering a subcutaneous option, the company aims to reduce the treatment burden on patients and improve their overall treatment experience. This new formulation could also streamline the administration process in clinical settings, potentially reducing healthcare costs and resource utilization.

Bristol Myers Squibb continues to lead the field of Immuno-Oncology with its innovative approaches to cancer treatment. Opdivo, as a programmed death-1 (PD-1) immune checkpoint inhibitor, has been instrumental in treating various cancers by harnessing the body’s immune system to combat tumor cells. Since its first approval in 2014, Opdivo has been a cornerstone in the treatment of melanoma, non-small cell lung cancer, renal cell carcinoma, and several other malignancies.


From Clinical Trials to Potential Approval: FDA Reviews Subcutaneous Opdivo for Broad Cancer Treatment

The company’s dedication to scientific excellence and patient-centric innovation is evident in its extensive global clinical development program for Opdivo. With over 35,000 patients treated across multiple clinical trials, Opdivo has significantly impacted the oncology landscape, offering hope and improved outcomes for patients worldwide. The FDA’s updated PDUFA goal date underscores the importance of regulatory review processes in bringing new, effective treatments to patients. As the December 29, 2024, goal date approaches, Bristol Myers Squibb remains focused on advancing its Biologics License Application and preparing for the potential approval and subsequent market introduction of subcutaneous nivolumab.

The BLA for subcutaneous nivolumab covers all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance after Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. The application is based on results from CheckMate -67T, a Phase 3 trial demonstrating non-inferior pharmacokinetics, efficacy, and consistent safety compared to the intravenous formulation.

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CheckMate -67T is a Phase 3 randomized, open-label trial evaluating subcutaneous administration of Opdivo co-formulated with Halozyme’s recombinant human hyaluronidase, compared to intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. This trial aims to bring a subcutaneous formulation of Opdivo to patients, involving 495 randomized patients. The co-primary endpoints are time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady-state (Cminss), with the objective response rate (ORR) as a key secondary endpoint.

Unlocking the Body’s Defense: Opdivo Leads Bristol Myers Squibb’s Fight Against Cancer

Bristol Myers Squibb’s vision is to transform patients’ lives through science. Their cancer research goal is to deliver medicines offering a better, healthier life, with the potential for a cure. The company’s deep understanding of causal human biology, cutting-edge capabilities, and differentiated research platforms position them uniquely in the cancer treatment landscape.

Opdivo, a programmed death-1 (PD-1) immune checkpoint inhibitor, uniquely harnesses the body’s immune system to restore anti-tumor immune response. Opdivo’s global development program, based on Bristol Myers Squibb’s Immuno-Oncology expertise, includes a broad range of clinical trials across all phases in various tumor types. Since its first regulatory approval in July 2014, Opdivo has treated over 35,000 patients and is currently approved in more than 65 countries.

Opdivo is indicated for numerous cancers, including unresectable or metastatic melanoma, non-small cell lung cancer, renal cell carcinoma, and more. The combination regimen of Opdivo and Yervoy has been particularly impactful, offering new hope for patients with metastatic melanoma and other advanced cancers. Safety information is paramount for patients and healthcare providers. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Early identification and management are essential to ensure the safe use of Opdivo and Yervoy. The full prescribing information for Opdivo and Yervoy includes detailed safety guidelines and monitoring recommendations.


Resource: Bristol Myers Squibb, May 21, 2024

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