by Dr. C.H. Weaver M.D. 8/2023
The U.S. Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) based on data from the Phase I/II ARROW clinical trial in which Gavreto produced durable clinical responses in people with RET fusion-positive NSCLC with or without prior therapy, and regardless of RET fusion partner or central nervous system involvement.
What is RET fusion positive NSCLC?
Genetic alternations in the RET receptor tyrosine kinase drive the development and growth of various cancers, including lung, thyroid, and other cancer types. RET over expression, activating mutations, and fusions result in the upregulation and/or over activation of RET tyrosine kinase activity. This dysregulation of RET activity plays a key role in the development and progression of cancer. RET fusion proteins are found in approximately 1% to 2% of NSCLC patients.
About Gavreto
Gavreto is a precision cancer medicine designed to target cancers with genomic alterations in the RET kinase, which include fusions and activating point mutations which lead to overactive RET signaling and uncontrolled cell growth. BLU-667 targets oncogenic RET alterations, including those that are resistant to multikinase inhibitors.
About the clinical data
A Phase I/II, clinical trial that evaluated Gavreto, in people with RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer (MTC), and other RET-altered solid tumors consisted of two parts: a dose escalation portion, which is complete, and an expansion portion in people treated with 400 mg of Gavreto, once daily.
The full FDA approval was based on data from 247 patients and 25 months of additional follow-up to assess durability of response.
Among 107 treatment-naïve patients the overall response rate was 78% with a median response duration of 13 months. Among 130 patients previously treated with platinum-based chemotherapy, the response rate was 63% with a median response duration of 39 months.
Common side effects with Gavreto were fatigue, constipation, musculoskeletal pain, diarrhea, fever, cough and hypertension.
Connect With Others for Support and information
CancerConnect was the first social network created for people with lung cancer. Founded by oncologists to support cancer patients and their caregivers, over 40 million individuals have accessed CancerConnect programs since 1997. CancerConnect is used by leading cancer centers like Dana Farber, Roswell Park and The James at Ohio State to support their patients. Join the conversation, ask questions, share your experience, and learn how the best cancer centers are treating lung cancer from others. Share your experience, ask a question, or start a conversation by posting on CancerConnect.
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