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Watch an exclusive “Ask the Expert” webinar: “Advancing Breast Cancer Treatment From Trials to Clinical Practice.”
Featuring renowned breast oncologist Dr. Eleonora Teplinsky, Head, Breast and Gynecological Medical Oncology, Valley-Mount Sinai Comprehensive Cancer Care, this session delves into the critical role of clinical trials in transforming breast cancer care, with a special focus on metastatic breast cancer (mBC).
**a summary of the discussion is below**
Cancer patients and their loved ones often wonder about the time it takes for new treatments to become available, and the process can seem lengthy and complex. This blog provides insights into the typical journey of a drug from research to patient use and highlights options for patients who may have missed a clinical trial opportunity.
1. The Lengthy Approval Process
- Discovery to Approval: Bringing a new cancer treatment from discovery to FDA approval often takes up to 10 years, sometimes even longer. This timeframe includes extensive research, clinical trials, and regulatory reviews to ensure the drug’s safety and effectiveness.
- Trial Design and Population: How quickly a trial progresses depends on the number of patients required and the trial’s endpoint. Some trials are designed with interim analyses at six or nine months to assess early effectiveness. If results are compelling, these checkpoints can accelerate the process.
2. What if You Missed a Clinical Trial?
- Missing a trial can happen for various reasons, including location constraints or strict eligibility criteria, like time since surgery. While it can be challenging to access a treatment not yet FDA-approved, some options may still exist:
- Insurance Approval: For drugs with compelling data, it may be possible to secure insurance coverage before FDA approval, although this is rare.
- Compassionate Use: In cases of significant benefit, companies may release a drug for compassionate use. This can be more likely if the drug has other FDA approvals in similar cancer types, as with Keytruda’s use in triple-negative breast cancer.
3. Exploring Other Clinical Trials and Related Drugs
- If a particular trial is missed, checking ClinicalTrials.gov or speaking with an oncologist can reveal if other trials are recruiting for the same drug or drug class. For example, if you missed a trial for a CDK4/6 inhibitor, other similar inhibitors may still be available, offering comparable benefits.
4. FDA Mechanisms to Speed Up Drug Approval
- The FDA has several pathways, like Fast Track, Breakthrough Therapy, and Priority Review, which aim to expedite approvals for treatments showing substantial benefit. This helps to ensure that life-saving drugs reach patients sooner when the data supports their efficacy and safety.
Final Thoughts
The journey from research to approval may be long, but the process ensures thorough testing and safety for patients. While missing a trial can be disappointing, alternative options and accelerated FDA pathways provide some hope for timely access to promising new treatments.
