US-based drugmaker Eli Lilly has launched its oral solid tumour therapy, selpercatinib, under the brand name Tanstrive in India, marking the first RET-targeted therapy for locally advanced or metastatic solid tumours with a rearranged during transfection (RET) gene. According to Economic Times, the launch follows marketing authorisation from the Central Drugs Standard Control Organisation (CDSCO) for patients with locally advanced or metastatic solid tumours with a rearranged during transfection (RET) gene. The drug is globally marketed as Retevmo and is approved to treat lung and thyroid cancer patients with a RET gene mutation or fusion.
Recent clinical data from the Phase 3 LIBRETTO-432 study presented at the American Society of Clinical Oncology (ASCO) annual meeting showed promising results for Tanstrive. As reported by ETPharma, the drug demonstrated an 83% reduction in disease recurrence risk among patients with early-stage lung cancer compared to placebo. Previous Phase 1/2 trial results (LIBRETTO-001) had reported an overall response rate of 62% among pretreated lung cancer patients and around 83% among naive participants, with a median overall survival of 47.6 months among pretreated patients. The drug is designed to block the RET tyrosine kinase signalling protein that drives cancer cell growth, binding to the RET kinase domain and preventing it from using Adenosine Triphosphate to pass on growth signals.
As reported by Economic Times, Tanstrive is priced at ₹2.15 lakh per box, which provides a 14-day treatment regimen with dosing administered twice daily. The drug is available in four tablet strengths: 40 mg, 80 mg, 120 mg and 160 mg, all administered orally twice daily. The prescription-only drug aims to block the RET tyrosine kinase, a signalling protein that drives cancer cell growth and slows tumour progression. The product label carries warnings of liver toxicity, hypertension and heart-related complications, and the drug received US Food and Drug Administration (USFDA) approval in 2020, followed by the European Medicines Agency (EMA) approval in 2021.
While the company did not share the potential market size for the drug, Economic Times reports that RET alterations are found in approximately 1-2 per cent of patients with non-small cell lung cancer (NSCLC) in India. However, new data reveals that RET alterations occur in around 1-2% of non-small cell lung cancers in India, about 50% of medullary thyroid cancers, and 10-20% of papillary thyroid cancers, while accounting for less than 1% of all tumour types overall. According to Lilly, RET alterations are rare but clinically actionable genetic drivers that can promote tumour growth across multiple cancer types, including NSCLC, thyroid cancers and certain solid tumours. As the first and only selective RET inhibitor approved in India for RET-altered solid tumours, regardless of tumour type, Tanstrive offers a precision, biomarker-guided option with demonstrated rapid and durable responses, including activity in patients with central nervous system involvement.
The approval brings India's first tumour-type-agnostic RET inhibitor to patients, allowing treatment to be selected on the basis of a tumour's genetic alteration rather than the organ where it originated. Tanstrive is approved for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion; adult and pediatric patients two years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, who require systemic therapy; adult and pediatric patients two years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, who require systemic therapy and who are radioactive iodine-refractory; and adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
According to Economic Times, Lilly onboarded selpercatinib under its $8 billion takeover of Loxo Oncology in 2019 – its biggest buyout over the past decade. The drug, once touted as a potential blockbuster candidate by the US giant, is yet to meet expectations, with industry estimates pegging its 2025 global sales at around $450 million. Dr. Rahul Kapur, Senior Director – Medical at Eli Lilly and Company (India), emphasized that "As the first and only selective RET inhibitor approved in India for RET-altered solid tumours regardless of tumour type and provides biomarker-guided option with demonstrated rapid and durable responses, including activity in patients with central nervous system involvement." Winselow Tucker, president and general manager of Eli Lilly and Company (India), stated that "The launch of Tanstrive in India reflects our commitment to bringing innovative, evidence-based therapies to patients with RET altered cancers, including those with limited treatment options across tumour types. As precision oncology continues to reshape cancer care, Tanstrive represents an important step forward -- expanding access to targeted therapies for patients in India." The company does not report its sales separately for individual products.
