August 2023: Pralsetinib (Gavreto, Genentech, Inc.) was given regular approval by the Food and Drug Administration for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), as determined by an FDA-approved test.
Based on the initial overall response rate (ORR) and durability of response (DOR) in 114 patients participating in the ARROW study (NCT03037385), a multicenter, open-label, multi-cohort trial, pralsetinib was previously given expedited approval for the NSCLC indication on Sept. 4, 2020. Based on information from 123 more patients and an additional 25 months of follow-up to gauge the longevity of the response, the conversion to regular approval was made.
A total of 237 patients with locally progressed or metastatic RET fusion-positive NSCLC showed efficacy. Patients were given pralsetinib until the disease progressed or the side effects were intolerable.
A Blinded Independent Review Committee (BIRC) decided that ORR and DOR were the key efficacy measures. The ORR was 78% (95% CI: 68, 85) among 107 patients who had never received therapy, and the median DOR was 13.4 months (95% CI: 9.4, 23.1). The ORR was 63% (95% CI: 54, 71) among 130 patients who had previously had platinum-based chemotherapy, and the median DOR was 38.8 months (95% CI: 14.8, not estimable).
Musculoskeletal discomfort, constipation, hypertension, diarrhoea, weariness, edoema, pyrexia, and cough were the most frequent side effects ( 25%).
400 mg of pralsetinib taken orally once per day is the recommended dosage. It is recommended to take pralsetinib on an empty stomach (no food for at least 2 hours prior to and at least 1 hour following the administration of pralsetinib).
View full prescribing information for Gavreto
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. His career is marked by significant contributions to stem cell biology, developmental biology, and innovative research techniques.
Research Highlights
Dr. Mittal's research has focused on several key areas:
1) Cardiovascular Development and Regeneration: He studied coronary vessel development and regeneration using zebrafish models1.
2) Cancer Biology: At Dartmouth College, he developed zebrafish models for studying tumor heterogeneity and clonal evolution in pancreatic cancer.
3) Developmental Biology: His doctoral work at Keio University involved identifying and characterizing medaka fish mutants with cardiovascular defects.
4) Stem Cell Research: He investigated the effects of folic acid on mouse embryonic stem cells and worked on cryopreservation techniques for hematopoietic stem cells.
Publications and Presentations
Dr. Mittal has authored several peer-reviewed publications in reputable journals such as Scientific Reports, Cardiovascular Research, and Disease Models & Mechanisms1. He has also presented his research at numerous international conferences, including the Stanford-Weill Cornell Cardiovascular Research Symposium and the Weinstein Cardiovascular Development Conference.
In summary, Dr. Nishant Mittal is a dedicated and accomplished researcher with a strong track record in cardiovascular and cancer biology, demonstrating expertise in various model systems and a commitment to advancing scientific knowledge through innovative research approaches.
