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Advancements in Cancer Therapy: The Role of the FDA's Office of Oncologic Diseases and Its Collaborations

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Medriva Correspondents
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Advancements in Cancer Therapy: The Role of the FDA's Office of Oncologic Diseases and Its Collaborations

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In the dynamic landscape of oncology, the Office of Oncologic Diseases (OOD) in collaboration with various FDA product centers has been instrumental in approving innovative drugs, biologic therapies, and oncology devices for the treatment of different types of cancer. These approvals encompass first-in-class entities, pediatric indications, and inclusive drug development, signifying substantial progress in the field of oncology.

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Cooperation with CBER and CDRH

The Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH) have also worked hand in hand with the OOD to review and regulate cellular cancer therapies and oncology devices, respectively. In 2023, CBER and OOD sanctioned new cellular therapy products for hematologic malignancy, and CDRH authorized 118 oncology devices, including in vitro diagnostics (IVDs).

Commitment to Safety and Innovation

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The FDA has consistently prioritized patient safety, issuing communication updates regarding Squamous Cell Carcinoma (SCC) in the capsule around breast implants. Moreover, it has held an advisory panel meeting on the design of multi-cancer detection (MCD) in vitro diagnostic devices, reflecting its commitment to innovative technologies.

The Oncology Center of Excellence (OCE) Rare Cancers Program

The OCE's Rare Cancers Program endeavors to promote the development of safe and effective new drugs and biologics to treat patients with rare cancers, defined as those affecting fewer than 200,000 people in the U.S. It addresses the challenges of developing new treatments for rare cancers by collaborating with other FDA offices, international regulatory agencies, and external stakeholders. The program leverages multiple projects and initiatives to create a context-specific approach tailored to the unique needs of each rare cancer.

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OCE's Extramural Research Projects

The OCE also encourages novel approaches to support therapeutic development in ultra-rare cancers. It funds active extramural research projects using specific funding mechanisms, and provides a comprehensive list of funded projects on its website for public reference.

Real World Evidence in Oncology

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The use of real-world evidence (RWE) in oncology offers comprehensive insights into treatment effectiveness and safety. RWE complements randomized controlled trials (RCTs) and plays a significant role in promoting collaboration and advancing oncology research and treatments. The FDA has recognized the importance of this evidence, launching the Oncology Real World Evidence Program to foster collaboration and generate RWE for regulatory purposes.

Streamlining Clinical Review Process

The FDA's OCE is collaborating with the FDA's product centers to streamline the clinical review process for oncology products. This collaboration aims to improve efficiency and consistency in the review process, ultimately benefiting patients by fast-tracking their access to potentially life-saving treatments.

These strides highlight the FDA's commitment to fostering innovation, promoting patient safety, and expediting the development and approval of effective treatments for cancer. This concerted effort by the OCE, OOD, CBER, and CDRH is revolutionizing the field of oncology, bringing hope to countless patients and their families.

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