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drugsProductApproved2020🇪🇺🇬🇧🇨🇳🇦🇺

Pralsetinib

Pralsetinib is the second selective RET pill for lung cancer, less used than selpercatinib after a change of owner and label.

ARROW: ORR ~72% treatment-naive RET-fusion NSCLC. Approved 2020; thyroid indications withdrawn in the US in 2023 after Roche returned rights to Blueprint (now Rigel). Remains an option in RET-fusion NSCLC.

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Pralsetinib
PubChem
Modality
Small-molecule kinase inhibitor (RET)
Mechanism
Selective RET inhibitor.
Brand / code
Gavreto
Medicare
Part D (self-administered)

Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).

Commercial insurance
covered with prior authorisation

Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.

Assistance programmes

Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.

Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.

Not yet researchedSearch NICE
Notes
Licensed 2021 for RET fusion-positive NSCLC; NICE appraisal outcome not verified. Check NICE.

Sources: NICE search: pralsetinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2020RET-fusion metastatic NSCLC (full approval 2023)

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
10 studies4 recruiting8 Phase 22 Phase 3
Search “Pralsetinib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Pralsetinib
intervention: Pralsetinib
Open on ClinicalTrials.gov →

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Latest papers

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Literature trend42 papers in the last 12 months-7% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Pralsetinib" OR ABSTRACT:"Pralsetinib" OR TITLE:"Gavreto" OR ABSTRACT:"Gavreto") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Pralsetinib, not a curated reading list.

Connected

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