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Rigel Pharmaceuticals issues Dear Health Care Provider letter relating to Gavreto (pralsetinib)
Rigel Pharmaceuticals, Inc. announced it is issuing a Dear Health Care Provider (DHCP) letter related to a new safety signal for Gavreto (pralsetinib) after consultation with the FDA. Gavreto is for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by a FDA approved test and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). The DHCP letter has been posted to the Gavreto Healthcare Provider website at www.gavreto-hcp.com. Patient safety is Rigel’s highest priority. We are committed to ensuring healthcare providers are aware of this update.
Healthcare providers and patients are encouraged to report adverse events in patients taking Gavreto to the Rigel Medical Communications Center at 1-800-983-1329 or producthelp@rigel.com. You may also report adverse events associated with taking Gavreto directly to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).