Breakthrough Therapy Designation (BTD) vs. Project ORBIS

 The Breakthrough Therapy Designation (BTD) and Project ORBIS are two regulatory designations that can be used to expedite the development and review of new drugs. BTD is a US Food and Drug Administration (FDA) designation, while Project ORBIS is an international collaboration between the FDA and other regulatory agencies.

Breakthrough Therapy Designation

BTD is intended for drugs that have the potential to provide a significant improvement over available therapies for serious or life-threatening conditions. To qualify for BTD, a drug must meet the following criteria:

• There must be preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
• The drug must address an unmet medical need.
• The drug must have the potential to be developed more quickly than through the standard drug development process.

Once a drug is granted BTD, the FDA will work with the drug developer to expedite the development and review process. This may include providing the developer with early access to the FDA, more frequent meetings with the FDA, and the opportunity to participate in rolling review.

Project ORBIS

Project ORBIS is an international collaboration between the FDA and other regulatory agencies to accelerate the review and approval of new cancer drugs. Under Project ORBIS, the FDA will work with other regulatory agencies to conduct concurrent review of new cancer drugs. This allows patients in multiple countries to have access to new cancer drugs sooner.

To be eligible for Project ORBIS, a drug must meet the following criteria:

• The drug must have been granted BTD by the FDA.
• The drug must be intended to treat cancer.
• The drug must be the subject of a marketing application in at least one other country that is participating in Project ORBIS.

Comparison

BTD and Project ORBIS are both designed to expedite the development and review of new drugs. However, they have different eligibility criteria and they offer different benefits.

BTD is a more flexible designation than Project ORBIS. BTD can be granted to drugs for any serious or life-threatening condition, while Project ORBIS is only available for cancer drugs. BTD also offers a wider range of benefits, such as early access to the FDA, more frequent meetings with the FDA, and the opportunity to participate in rolling review.

Project ORBIS, on the other hand, offers the benefit of concurrent review by multiple regulatory agencies. This can help to speed up the review process and get new cancer drugs to patients sooner.

BTD and Project ORBIS are two valuable tools that can be used to expedite the development and review of new drugs. If you are developing a new oncology drug, consider these designations to see if either of these designations is right for you.