GAVRETO® (pralsetinib) has been withdrawn for RET-mutant medullary thyroid cancer (MTC) in the US10/2023
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June 30, 2023
Dear Patient Advocates:
Earlier today, Genentech announced that it is voluntarily withdrawing the U.S. indication of GAVRETO® (pralsetinib) for RET-mutant medullary thyroid cancer (MTC). This decision was not based on any new safety or efficacy data and does not impact GAVRETO’s other approved indications for RET fusion-positive thyroid cancer and non-small cell lung cancer.
Based on results from the Phase 1/2 ARROW clinical trial, the FDA granted accelerated approval to GAVRETO for RET-mutant MTC in December 2020, with a follow-up to conduct a confirmatory Phase 3 clinical trial in patients with MTC. Unfortunately, we have determined that we will not be able to complete the required Phase 3 study and, based on recent discussions with the U.S. FDA, we have made the difficult decision to voluntarily withdraw the MTC indication. As a result of this change, Genentech and Blueprint Medicines will cease marketing GAVRETO for MTC effective today.
Genentech and Blueprint Medicines are committed to advancing scientific innovation that improves the lives of people living with cancer, as well as enabling patient access to our medicines. We know that any change in the availability of a medicine can create uncertainty and confusion, and that is why we want to communicate clearly to the MTC community about what this change may mean for patients with MTC who are receiving GAVRETO today:
- We encourage all patients with MTC who are receiving GAVRETO to talk to their physician about what the withdrawal means for them and their current treatment. GAVRETO remains commercially available, and patients can continue to receive GAVRETO as determined medically appropriate by their physician.
- Patients who are receiving financial assistance through the Genentech Oncology Co-Pay Assistance Program or free drug through the Genentech Patient Foundation will have no immediate interruption in these services.
- It is possible that some insurers may no longer pay for GAVRETO to treat MTC. Patients who have changes to their insurance or who can’t pay for their medicine can call the Genentech Patient Resource Center at 1-877-436-3683 to speak to one of our patient support specialists about available financial assistance.
Our advocacy teams are ready to help you and your organization address questions that may come up from patients and caregivers about the withdrawal. In addition, we offer and welcome continued communication and transparency with the community as we work through this change.
Thank you for your continued partnership and unwavering support for patients.
Patient Advocacy RelationsGenentech
VP, Global Patient Affairs