Real Time Oncology Review: A Game-Changer in Cancer Drug Approvals

by | Nov 9, 2023 | FDA, Pharma, Pharmaceuticals, Regulatory

The battle against cancer is ongoing, and one of the key fronts in this fight is the development and approval of new oncology drugs. The FDA plays a pivotal role in ensuring that innovative cancer therapies reach patients in a timely and safe manner. In recent years, the FDA has introduced a groundbreaking initiative known as Real-Time Oncology Review (RTOR), which is revolutionizing the way cancer drugs are reviewed and approved. In this blog, we’ll delve into what RTOR is, its significance, and how it’s changing the landscape of cancer treatment approvals.

Real-Time Oncology Review is a program established by the FDA to streamline the review process for oncology drugs. It aims to accelerate the evaluation and approval of cancer treatments while maintaining the highest standards of safety and efficacy. Traditional drug approval processes can be lengthy, often involving multiple cycles of review and communication between the FDA and drug developers. RTOR seeks to expedite this process by facilitating continuous communication and early collaboration between the FDA and drug sponsors.

Key Features of RTOR

  1. Seamless Communication: RTOR enables real-time communication between the FDA and drug developers. It allows sponsors to submit their data incrementally as it becomes available during the drug development process. This ongoing dialogue helps identify and address issues earlier in the review process, potentially saving valuable time.
  2. Rolling Review: Unlike the traditional review process, where the FDA waits until all data is submitted for a comprehensive evaluation, RTOR allows the agency to start reviewing individual sections of a New Drug Application (NDA) or Biologics License Application (BLA) as they are submitted. This rolling review approach can significantly reduce the time required for a complete evaluation.
  3. Faster Decision-Making: With the information being reviewed in real-time, the FDA can make quicker decisions, potentially shortening the time between submission and approval. This is especially crucial in the context of cancer treatment, where timely access to innovative therapies can be a matter of life and death.

Since its introduction, RTOR has had a substantial impact on the approval of cancer drugs. For example, in the case of the drug pembrolizumab (Keytruda), a groundbreaking immunotherapy for certain types of cancer, RTOR reduced the time between application submission and approval from months to just a few weeks. This rapid approval allowed patients to benefit from the treatment much sooner.

Real-Time Oncology Review is a transformative initiative by the FDA that is changing the landscape of oncology drug approvals. By promoting faster and more efficient reviews, RTOR holds the promise of improving patient access to innovative cancer therapies, saving lives, and encouraging continued innovation in the field. As RTOR continues to evolve and expand, it is likely to play an increasingly critical role in the fight against cancer, offering hope to countless individuals and their families.

EMMA International’s experts can help support your drug product from concept to commercialization, call us at 248-987-4497 or email to learn more.

Emma International

Emma International

More Resources

Ready to learn more about working with us?

Pin It on Pinterest

Share This