Additional information on clinical trials
When reviewing the study results for TALVEY®, you may have questions about what an accelerated approval is, clinical trials, or the data itself. This page is your resource to have those questions answered.
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This section provides helpful context for the accelerated approval that TALVEY® received.
How does an accelerated approval work?
The U.S. Food and Drug Administration (FDA) can give an accelerated approval to treatments for serious diseases based on signs (early clinical data) of a drug's expected benefit. This allows the drug to be available to patients faster than the traditional process would usually allow.
The U.S. Food and Drug Administration (FDA) can give an accelerated approval to treatments for serious diseases based on signs (early clinical data) of a drug's expected benefit. This allows the drug to be available to patients faster than the traditional process would usually allow.
What happens after an accelerated approval?
The research behind the drug is not finished and it must be studied further. Additional clinical trials must be performed to confirm the clinical benefit. If the additional data do not confirm the drug’s assumed safety or effectiveness, then the FDA will remove the drug from the market.
The research behind the drug is not finished and it must be studied further. Additional clinical trials must be performed to confirm the clinical benefit. If the additional data do not confirm the drug’s assumed safety or effectiveness, then the FDA will remove the drug from the market.
Why do we have accelerated approvals?
Accelerated approvals exist because they can help bring drugs to people when treatment options may be limited or unavailable. This is especially helpful for diseases where measuring the effect of a treatment can take a long time.
Accelerated approvals exist because they can help bring drugs to people when treatment options may be limited or unavailable. This is especially helpful for diseases where measuring the effect of a treatment can take a long time.
Want to learn more regarding the FDA’s Accelerated Approval Program?
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Clinical trial
A clinical trial is a type of research study where new medicines or treatments are tested in volunteers to see if they are safe and if they work. Clinical studies for the U.S. Food and Drug Administration (FDA) approval of prescription drugs will have “endpoints” that are established before the study begins. These are specific measures used for assessing the effectiveness and safety of the medicine or treatment.
Accelerated approval
An accelerated approval can be granted to a drug or treatment by the FDA allowing it to be given to patients earlier than the normal process would allow for. This approval is always granted with the requirement that additional research is performed to confirm the safety and effectiveness of the treatment.
Scroll to the top to learn more about the accelerated approval of TALVEY®.
Study recruitment
When a clinical trial begins, researchers in the trial look for people who fit a certain description, called eligibility criteria, to fill the study. Some trials may include a long-term follow-up period where patients continue to be enrolled outside of the established period for the primary analysis. The intent of this may be to gain additional information regarding the safety and effectiveness of the treatment over time.
Understanding biases
A bias is a flaw in the design or analysis of a clinical trial that leads to incorrect conclusions. Certain aspects of a clinical trial are meant to reduce the chance that study results are influenced by biases.
Treatment response
Treatment response measures how well the multiple myeloma in your body reacts to treatment. If you respond to treatment, it means that your cancer shrank or disappeared after treatment.
A complete response
A complete response is when your healthcare team finds no signs or symptoms of multiple myeloma in your body after treatment, as seen through imaging or other specific blood and bone marrow tests.
Your healthcare team may use an even more sensitive test to look for signs of multiple myeloma; if they don’t find any signs using this test, this is called a stringent complete response. A complete response does not always mean that your cancer is cured.
A partial response
A partial response is when your healthcare team finds that there are fewer signs or symptoms of multiple myeloma in your body after treatment.
If your healthcare team finds very few signs or symptoms of multiple myeloma, this is called a very good partial response.
Continuing to respond to treatment
If you continue to respond to treatment, it means that your multiple myeloma has not grown or come back after treatment.
The length of time before your cancer starts to grow again is called the duration of your response. The duration of response is only measured if you experience a response.
Median
The middle number in a set of numbers or results. The median is found by taking a set of numbers (in order) and choosing the middle one. It serves as a sign for the “typical” result for the majority of patients.
HCP, healthcare provider; REMS, Risk Evaluation and Mitigation Strategy.
HCP, healthcare professional; REMS, Risk Evaluation and Mitigation Strategy.