Gavreto (pralsetinib) / CStone Pharma, Allist, Rigel Pharmaceuticals, Sanofi - LARVOL DELTA

Efficacy and safety of pralsetinib in RET fusion-positive solid tumors: Final data from the ARROW trial. (ASCO 2025) - P1/2 | "In the phase 2 portion of this trial, responses were observed in many tumor types (Table). Pralsetinib demonstrated robust and durable anti-tumor activity with an ORR of 46.4%. These data validate RET fusions as a tissue-agnostic target with sensitivity to RET inhibition and activity beyond NSCLC and thyroid cancer, further supporting the promising potential of pralsetinib to address the unmet medical need in these patients."

Clinical • Anemia • Endocrine Cancer • Hypertension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Thyroid Gland Carcinoma • RET

How to manage radioiodine-refractory thyroid cancer in the era of precision medicine. (PubMed, Drugs Context) - "Three multi-kinase inhibitors have been approved for this indication: lenvatinib and sorafenib as a first-line option and cabozantinib as a second-line option...Thus, additional selective inhibitors have been approved: larotrectinib and entrectinib for NTRK + tumours, selpercatinib and pralsetinib for RET + tumours, and crizotinib, alectinib and lorlatinib for ALK + tumours. Such a personalized approach increases clinical benefit whilst minimizing adverse events. Future studies should focus on the combination of tyrosine kinase inhibitors and immune-checkpoint inhibitors; currently, there is no strong evidence that redifferentiation strategies add clinical benefit in terms of overall survival or progression-free survival."

Journal • Review • Oncology • Solid Tumor • Thyroid Gland Carcinoma • ALK • NTRK

Clinical Impact Associated With Dose Reductions of Selpercatinib and Pralsetinib in Advanced RET-rearranged NSCLC (IASLC-WCLC 2026) - "Conclusions : Dose reduction of selective RET inhibitors was not associated with inferior real-world PFS or TTNT, nor with increased rates of intracranial progression. These findings suggest that improving treatment tolerability through dose modification does not compromise clinical outcomes, although larger studies are needed to confirm these observations."

Clinical • Metastases • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

RET Fusion in Solid Tumors (IASLC-WCLC 2026) - "No statistically significant differences in mPFS were detected between selpercatinib, pralsetinib, and other RET-TKIs (13 vs. 12 vs. 10 months; P=0.37), nor between first-line and subsequent-line administration (12 vs. 13 months, P=0.91). Co-occurring driver gene alterations predicted poorer outcomes. RET-TKIs were generally well tolerated with distinct safety profiles."

Hypertension • Infectious Disease • Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • KIF5B • RET • TP53

Health-Related Quality of Life (HRQoL) Among Patients With Advanced or Metastatic RET-Fusion-Positive NSCLC Treated With Pralsetinib in ARROW (ESMO 2026) - No abstract available

Clinical • HEOR • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • RET

Final Efficacy and Safety Data From the Phase I/II ARROW Study of Pralsetinib in Patients With Advanced RET Fusion-Positive Non-Small Cell Lung Cancer. (PubMed, J Clin Oncol) - P1/2 | "Safety was consistent with previous ARROW reports; no hypersensitivity was reported in patients receiving prior immunotherapies. Pralsetinib produced robust, durable responses with manageable safety in treatment-naïve and previously treated patients with RET fusion-positive NSCLCs, confirming previous findings with longer follow-up."

Journal • P1/2 data • Cardiovascular • Hematological Disorders • Hypertension • Immunology • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thyroid Gland Carcinoma • RET

Efficacy and safety of pralsetinib in RET fusion–positive solid tumors: Data from the TAPISTRY trial. (ASCO 2026) - P2 | "Pralsetinib demonstrated robust and durable activity against RET fusion-positive solid tumors, with an ORR of 67%. These data validate RET fusions as a tissue-agnostic target with sensitivity to RET inhibition, suggesting therapeutic utility of pralsetinib. Efficacy summary by tumor type."

Clinical • Hypertension • Oncology • Sarcoma • Solid Tumor • Thyroid Gland Carcinoma • RET

Efficacy and Safety of Pralsetinib in RET Fusion-Positive Solid Tumors: Pooled Analysis of the ARROW and TAPISTRY Trials (ESMO 2026) - No abstract available

Retrospective data • Oncology • Solid Tumor • RET

Pralsetinib for Advanced RET Fusion-Positive Thyroid Cancer: Results from the TAPISTRY Clinical Trial (ESMO 2026) - No abstract available

Clinical • Metastases • Oncology • Solid Tumor • Thyroid Gland Carcinoma • RET

Emergent peripheral vascular disease (PVD) in medullary thyroid carcinoma (MTC) patients treated with pralsetinib: a case series (ETA 2026) - "Two patients were previously treated with other systemic therapies before starting pralsetinib (vandetanib and vandetanib followed by cabozantinib)... Our case highlights a rare but serious adverse effect possibly associated with pralsetinib warranting increased clinical awareness and monitoring. Possible pathogenic mechanisms could be related to inhibition of fibroblast growth factor (FGF) receptor-1 inhibition or other off-target effects on FGF-23 activity leading to hyperphosphatemia. Further studies are needed to better characterize the incidence and mechanism."

Clinical • Cardiovascular • Chronic Kidney Disease • Coronary Artery Disease • Diabetes • Diabetic Nephropathy • Heart Failure • Hypertension • Metabolic Disorders • Myocardial Infarction • Nephrology • Oncology • Peripheral Arterial Disease • Renal Disease • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma • FGF23

Safety and efficacy of pralsetinib in RET fusion-positive non-small cell lung cancer including as first-line therapy: update from the ARROW trial. (PubMed, Ann Oncol) - P3 | "Pralsetinib treatment produced robust efficacy and was generally well tolerated in treatment-naïve patients with advanced RET fusion-positive NSCLC. Results from the confirmatory phase III AcceleRET Lung study (NCT04222972) of pralsetinib versus standard of care in the first-line setting are pending."

Journal • Cardiovascular • Hematological Disorders • Hypertension • Immunology • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • RET

Clinical Outcomes With First-Line Pralsetinib vs Other Accepted Therapies in ARROW Patients with RET Fusion-Positive NSCLC (ESMO 2026) - No abstract available

Clinical • Clinical data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • RET

Health-Related Quality of Life Among Arrow Patients with Advanced or Metastatic RET-Altered Thyroid Cancers Treated with Pralsetinib (ATA 2026) - No abstract available

Clinical • HEOR • Metastases • Oncology • Solid Tumor • Thyroid Gland Carcinoma

Safety and efficacy of APS03118, a next-generation RET inhibitor, in patients with non-small cell lung cancer (NSCLC): Results from a phase I clinical trial. (ASCO 2026) - P1 | "This report focuses mainly on the NSCLC cohorts, including treatment-naïve and previously treated patients with 1-4 lines of therapy, including six different SRIs, (e.g., pralsetinib and selpercatinib). APS03118 shows highly promising clinical activity in both treatment-naïve and SRI failed NSCLC patients harboring RET fusions. Its survival benefit may result from potent inhibition of RET and YES1. The safety profile is manageable, characterized primarily by reversible enzyme elevations."

Clinical • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • RET

Efficacy and safety of pralsetinib in patients with advanced RET-fusion-positive NSCLC: Final data from the phase 1/2 ARROW study. (ASCO 2025) - P1/2 | "Pralsetinib produced clinically meaningful and durable responses in patients with RET-fusion-positive NSCLC (regardless of prior therapies) with a manageable safety profile, confirming with this longer follow up previously published results. aPer FDA censoring rule."

Clinical • Metastases • P1/2 data • Anemia • Hypertension • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • RET

Efficacy and safety of pralsetinib as first-line treatment of RET fusion–positive advanced or metastatic non–small cell lung cancer (NSCLC): The phase 3 AcceleRET-Lung study. (ASCO 2026) - P3 | "In a Phase 3 study, pralsetinib met the primary PFS end point and had a significantly greater and more durable ORR vs SOC, confirming the clinical utility of pralsetinib in RET fusion-positive NSCLC. Monitoring for infections with pralsetinib is warranted. Efficacy outcomes."

Clinical • Metastases • P3 data • Cardiovascular • Hypertension • Infectious Disease • Lung Cancer • Nephrology • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • RET

Addressing challenges with real-world synthetic control arms to demonstrate the comparative effectiveness of Pralsetinib in non-small cell lung cancer. (PubMed, Nat Commun) - P1/2 | "Using the example of pralsetinib from a RET fusion-positive aNSCLC single-arm trial (NCT03037385), we demonstrate a relative survival benefit when compared to pembrolizumab monotherapy and pembrolizumab with chemotherapy RWD cohorts. Overall, the study provides evidence in favour of pralsetinib as a first-line treatment for RET fusion-positive aNSCLC. The quantification of potential bias performed in this study can be used as a template for future studies of this nature."

HEOR • Journal • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • RET

Pralsetinib for Advanced RET Fusion-Positive Thyroid Cancer: Pooled Analysis from the Arrow and Tapistry Clinical Trials (ATA 2026) - No abstract available

Metastases • Retrospective data • Oncology • Solid Tumor • Thyroid Gland Carcinoma • RET

Gavreto: Newly added patent in Orange Book (Orange Book) - Expiry on Apr 19, 2043

Patent • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Thoracic Cancer • Thyroid Gland Medullary Carcinoma

Efficacy and safety of pralsetinib in advanced or metastatic RET-altered thyroid cancer (TC): Final analysis of the phase 1/2 ARROW study. (ASCO 2026) - P1/2 | "The final analysis of ARROW confirms that pralsetinib yields clinically meaningful and durable responses in patients with RET-altered TC and MTC with a manageable safety profile consistent with prior reports. Efficacy summary. NE, not evaluable; NR, not reached."

Clinical • Metastases • P1/2 data • Hepatology • Infectious Disease • Liver Failure • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • Thyroid Gland Carcinoma • RET

PULMONARY ADVERSE EVENTS ASSOCIATED WITH PRALSETINIB: A FAERS ANALYSIS (CHEST 2026) - No abstract available

Adverse events

Pan-cancer efficacy of pralsetinib in patients with RET fusion-positive solid tumors from the phase 1/2 ARROW trial. (PubMed, Nat Med) - P1/2 | "The most common grade ≥3 treatment-related adverse events were neutropenia (31%) and anemia (14%). These data validate RET as a tissue-agnostic target with sensitivity to RET inhibition, indicating pralsetinib's potential as a well-tolerated treatment option with rapid, robust and durable anti-tumor activity in patients with diverse RET fusion-positive solid tumors."

Journal • P1/2 data • Pan tumor • Endocrine Cancer • Hematological Disorders • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • CCDC6 • KIF5B • NCOA4 • RET

Clinical factors driving use of RET inhibitor pralsetinib and associated real-world outcomes in RET fusion–positive NSCLC: A retrospective chart review. (ASCO 2026) - "In this retrospective chart review, pralsetinib was used across treatment lines with high real-world response rates, consistent with results from the ARROW trial. Treatment selection was influenced by specific clinical factors including patient comorbidities, ECOG performance status, and safety concerns, with AE-driven switching uncommon yet associated with continued responses."

Real-world • Real-world evidence • Retrospective data • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • RET

Real-World Outcomes of RET Inhibitor Switching in RET Fusion–Positive NSCLC Patients (IASLC-TTLC 2026) - "BACKGROUND The receptor tyrosine kinase RET (REarranged during Transfection) inhibitors (RETi) pralsetinib and selpercatinib are approved for metastatic RET fusion positive NSCLC. CONCLUSION Among patients who switched RETi's due to an AE, response rates exceeded 60%, aligning with the 50% response rate observed in the RET MAP registry. Collectively, these results underscore that switching from one RET inhibitor to another can be efficacious, particularly for patients who must discontinue initial therapy because of adverse events."

Clinical • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • RET

Activity of Bevacizumab Combined with Chemotherapy in Advanced RET-Rearranged Non-Small Cell Lung Cancer (IASLC-TTLC 2026) - "Functional studies used selpercatinib- and pralsetinib-resistant Lc2/AD-derived cell lines (BluR, LoxoR) exposed to bevacizumab ± platinum-based chemotherapy, assessing vasculogenic mimicry, 3D spheroid viability, apoptosis and migration...SRI-resistant cells exhibited VEGF-axis hyperactivation (↑VEGFA/VEGFC; ↑p-VEGFR1/2) and intrinsic vasculogenic mimicry; bevacizumab impaired mimicry dose-dependently and, combined with carboplatin/pemetrexed or carboplatin/paclitaxel, reduced viability, increased apoptosis, limited migration, and shrank viable spheroid cores (Figure C)... These findings reveal angiogenesis as a therapeutic vulnerability in RET-rearranged NSCLC and support bevacizumab plus chemotherapy as a clinically meaningful strategy where selective RET inhibitors are unavailable or after resistance, providing a compelling rationale for clinical trials testing angiogenesis inhibition in this underserved population."

IO biomarker • Metastases • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • FLT1 • KDR • VEGFC