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Gavreto (pralsetinib) is an oral, once-daily kinase inhibitor that selectively targets RET (rearranged during transfection) gene alterations, including RET fusions. It is designed for patients whose tumors are driven by these specific genetic alterations, identified through FDA-approved molecular testing.
Gavreto is FDA-approved (accelerated approval, granted in September 2020) for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
Gavreto previously also held US approval for RET-mutant and RET fusion-positive thyroid cancer, but that indication was voluntarily withdrawn by the manufacturer in 2023 for commercial reasons. Similarly, the European Union marketing authorization for Gavreto was withdrawn in October 2024 at the marketing authorization holder's request, also for commercial reasons rather than a safety or efficacy finding. Gavreto is currently marketed only in the United States, and only for the NSCLC indication above.
Pralsetinib inhibits RET kinase activity, blocking abnormal signaling that drives tumor growth in cancers carrying RET gene fusions.
The recommended dose is 400 mg (four 100 mg capsules) taken orally once daily on an empty stomach, until disease progression or unacceptable toxicity. Dose reductions to 300 mg, 200 mg, or 100 mg daily may be required to manage side effects, at the treating physician's discretion.
Gavreto carries several important safety warnings that require close monitoring by the treating oncologist.
Severe, life-threatening, and fatal cases have occurred. Monitor for new or worsening respiratory symptoms and interrupt or discontinue Gavreto as needed.
Do not initiate Gavreto in patients with uncontrolled hypertension. Monitor blood pressure regularly and manage with antihypertensive therapy.
Elevated liver enzymes can occur. Monitor liver function tests before and periodically during treatment.
Serious, including fatal, hemorrhagic events have been reported. Discontinue permanently for severe or life-threatening hemorrhage.
Monitor patients with rapidly proliferating tumors and high tumor burden for signs of tumor lysis syndrome.
Withhold Gavreto for at least 5 days prior to elective surgery.
Gavreto can cause fetal harm. Advise patients of reproductive potential to use effective contraception during treatment and for 2 weeks after the final dose.
Monitor ECG and electrolytes in patients at risk of QTc prolongation.
Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.
Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.
Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.
Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.
Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.
Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.
Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.
Gavreto (pralsetinib) received FDA accelerated approval in September 2020 for metastatic RET fusion-positive NSCLC and is currently commercialized in the United States by Rigel Pharmaceuticals, which acquired the US rights to the product from Blueprint Medicines in 2024.
Gavreto is currently marketed only in the United States. Its earlier US thyroid cancer indication was voluntarily withdrawn in 2023, and its European Union marketing authorization was withdrawn in October 2024 — both were commercial decisions by the manufacturer, not the result of a safety or efficacy finding by regulators. This status is disclosed here for full transparency, since it affects where and how the medicine can be sourced.
Import of Gavreto through a Named Patient Program requires a valid prescription from the treating oncologist, confirmation of RET fusion-positive status via an FDA-approved molecular test, and supporting clinical documentation as required by Indian regulatory authorities.
NPP sources Gavreto directly from the authorized US supply chain to ensure product authenticity and regulatory compliance.
Gavreto is sourced through verified, GDP-compliant channels from its authorized US supply chain to ensure authenticity and quality.
Gavreto capsules should be stored at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F to 86°F). The medicine should be protected from moisture.
Once sourced, Gavreto is packed and transported under appropriate temperature-controlled conditions to preserve product integrity throughout the import process, with tracking and updates provided at each stage of delivery to the patient or treating hospital in India.
Patients across India can access Gavreto through NPP's regulated import pathway, with oncology specialists in major cities supporting the treatment process.
Leading oncology centers in Mumbai support RET fusion-positive NSCLC testing and treatment coordination for Gavreto access.
Delhi's major cancer hospitals assist patients with molecular testing and prescription support for Gavreto.
Bangalore's oncology network offers access to RET-testing and treatment planning for eligible NSCLC patients.
Chennai-based specialists coordinate Gavreto access alongside comprehensive lung cancer care.
Hyderabad's cancer care institutions support patients pursuing Gavreto therapy following confirmed RET fusion testing.
Kolkata's oncology centers help coordinate documentation and treatment access for Gavreto.
Pune-based oncologists assist with RET fusion-positive NSCLC diagnosis and Gavreto treatment planning.
Ahmedabad's specialty hospitals support the import and treatment process for Gavreto.
Kochi's oncology units assist patients with the documentation needed for Gavreto access.
Chandigarh's cancer care centers support Gavreto treatment coordination for patients from North India.
Jaipur's oncology specialists help patients navigate the Gavreto access process.
Lucknow-based cancer centers assist patients pursuing Gavreto therapy.
Bhubaneswar's oncology institutions support access to Gavreto for eligible patients.
Guwahati's specialists help coordinate Gavreto access for patients across the Northeast.
Patients in other cities across India can also access Gavreto through NPP's nationwide coordination network.
Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 09 September 2026
Sources: FDA • CDSCO
Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 09 September 2026
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