Retevmo® (Selpercatinib)

Retevmo® (Selpercatinib)

Description

Selpercatinib 40mg and 80mg Capsules — RET Kinase Inhibitor for RET-Altered Lung and Thyroid Cancers

Additional Information

Retevmo® (Selpercatinib) — Precision RET Inhibitor for RET-Altered Cancers

A Sourcing Guide for Hospitals Supporting Named Patient Access

Retevmo® (Selpercatinib) is a highly selective RET kinase inhibitor indicated, according to its approved prescribing information, for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), and adult and paediatric patients aged 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) or RET fusion-positive thyroid cancer requiring systemic therapy. As with all biomarker-directed oncology therapies, the decision to prescribe Retevmo, including RET alteration testing, rests entirely with the treating oncologist, in accordance with the approved label. This page provides sourcing and procurement information for hospitals and pharmacies, not clinical or treatment guidance.

As both a trusted medicine distributor in Delhi and a licensed pharmaceutical distributor in Delhi, A.K. Pharma supports hospitals sourcing genuine Retevmo (Selpercatinib) capsules, manufactured by Eli Lilly and Company. As Retevmo does not currently hold routine commercial availability in India, access is typically supported through a Named Patient Program pathway with a valid prescription — A.K. Pharma can guide hospitals and patients through this process alongside our Named Patient Program.


What is Retevmo (Selpercatinib)?

Retevmo contains Selpercatinib, a small-molecule kinase inhibitor designed to selectively target the RET (REarranged during Transfection) receptor tyrosine kinase.

RET Alterations as Oncogenic Drivers:

According to published oncology literature, alterations in the RET gene — including gene fusions and specific point mutations — can result in constitutively active RET signalling, driving uncontrolled cell proliferation in a subset of non-small cell lung cancers and thyroid cancers. RET fusions are found in a small percentage of NSCLC cases, while specific RET mutations are a well-established driver in a significant proportion of medullary thyroid cancer cases, both sporadic and hereditary.

Selpercatinib’s Mechanism: By selectively inhibiting wild-type RET as well as various RET mutants and RET-containing fusion products, Selpercatinib blocks the constitutively active signalling driving tumour growth in RET-altered cancers, according to the manufacturer’s prescribing information. Published pharmacology data also notes activity against VEGFR1, VEGFR3, and FGFR1-3, though its primary therapeutic rationale centres on selective RET pathway inhibition, distinguishing it from earlier multi-kinase inhibitors with broader but less selective RET activity.

Full prescribing information is available at the FDA label for Selpercatinib, with additional background on RET-altered cancers available via the National Cancer Institute and the American Thyroid Association.


Clinical Studies and Evidence

LIBRETTO-001 Trial (Selpercatinib Across RET-Altered Cancers)
Published in the New England Journal of Medicine (2020), the pivotal LIBRETTO-001 trial evaluated Selpercatinib across cohorts of patients with RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer. Key findings demonstrated substantial overall response rates across these RET-altered cancer types, including in patients who had progressed on prior systemic therapy, as well as meaningful intracranial response in patients with brain metastases. This basket-trial design across multiple RET-altered tumour types supported the medicine’s initial accelerated approval and its designation as a genuinely biomarker-driven, tumour-agnostic-informed therapy within its approved indications.

For broader clinical guidance on biomarker-directed lung and thyroid cancer treatment, the American Society of Clinical Oncology (ASCO) and NCCN Guidelines publish ongoing treatment recommendations.


Available Strengths

Retevmo is supplied as:

PresentationStrength
Retevmo Capsules40mg per capsule
Retevmo Capsules80mg per capsule

Standard Dosing (per approved prescribing information):

Body WeightDose
Less than 50kg120mg orally twice daily
50kg or greater160mg orally twice daily

Dosing continues until disease progression or unacceptable toxicity, per the approved label.


Indications — What Retevmo is Used For

RET Fusion-Positive Non-Small Cell Lung Cancer:

  • Adult patients with metastatic RET fusion-positive NSCLC, as detected by an approved test

RET-Mutant Medullary Thyroid Cancer (MTC):

  • Adult and paediatric patients aged 12 years and older with advanced or metastatic RET-mutant MTC requiring systemic therapy

RET Fusion-Positive Thyroid Cancer:

  • Adult and paediatric patients aged 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer requiring systemic therapy who are radioactive iodine-refractory, where radioactive iodine is appropriate

RET alteration testing using an approved diagnostic test is required before initiating Retevmo therapy, per the approved prescribing information.

For detailed indication information refer to MedlinePlus Selpercatinib.


Key Benefits of Retevmo

Highly Selective RET Targeting
Selpercatinib’s design as a selective RET inhibitor, rather than a broader multi-kinase inhibitor, is associated with a differentiated efficacy and tolerability profile compared to earlier-generation agents with off-target activity.

Efficacy Across Multiple RET-Altered Tumour Types
LIBRETTO-001 demonstrated meaningful response rates across RET fusion-positive NSCLC, RET-mutant MTC, and RET fusion-positive thyroid cancer, providing a single therapeutic option across several distinct RET-driven cancers.

Demonstrated Intracranial Activity
Response data in patients with brain metastases is a clinically relevant consideration given the frequency of CNS involvement in metastatic NSCLC.

Biomarker-Directed Precision Approach
By requiring RET alteration testing before treatment, Retevmo represents a precision oncology approach, directing therapy specifically toward tumours confirmed to carry a RET fusion or mutation.


Dosage and Administration — General Reference

Dosing of Retevmo is determined by the prescribing oncologist according to the approved label and patient body weight. General administration information from the manufacturer’s prescribing information includes:

  • Administered orally, twice daily, based on body weight
  • May be taken with or without food
  • Capsules should be swallowed whole
  • Should not be administered for at least 2 weeks following major surgery, until adequate wound healing has occurred

Monitoring (per manufacturer prescribing information):

  • Liver function testing (ALT and AST), monitored prior to initiating therapy, every 2 weeks during the first 3 months, then monthly thereafter, given reported hepatotoxicity
  • Blood pressure monitoring, given reported hypertension; blood pressure should be optimised prior to initiating treatment
  • Pulmonary assessment, given reported interstitial lung disease/pneumonitis
  • ECG and electrolyte monitoring, given reported QT interval prolongation
  • Thyroid-stimulating hormone monitoring, given reported hypothyroidism
  • Bleeding risk assessment, given reported haemorrhagic events

Full dosing guidelines are available in the manufacturer’s official prescribing information and should always be followed exactly as directed by the treating oncologist.


Who Should Use Retevmo

Retevmo is prescribed by oncologists and endocrine oncology specialists for:

  • Adult patients with metastatic RET fusion-positive NSCLC
  • Adult and paediatric patients aged 12 and older with advanced or metastatic RET-mutant medullary thyroid cancer requiring systemic therapy
  • Adult and paediatric patients aged 12 and older with advanced or metastatic RET fusion-positive, radioactive iodine-refractory thyroid cancer requiring systemic therapy

Retevmo is prescribed by oncologists specialising in lung and thyroid malignancies, typically at centres with RET biomarker testing capability. A.K. Pharma supports hospitals in accessing Retevmo through appropriate import channels across India.


Possible Side Effects

Common side effects reported in clinical trials include oedema, diarrhoea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.

Serious side effects include:

Hepatotoxicity: Elevated liver enzymes have been reported; regular liver function monitoring is required per the approved prescribing information, with dose modification guidance based on severity.

Interstitial Lung Disease/Pneumonitis: Severe pulmonary adverse events have been reported; prompt evaluation of new or worsening respiratory symptoms is recommended per the approved label.

Hypertension: Commonly reported; blood pressure should be optimised before starting therapy and monitored regularly throughout treatment.

QT Interval Prolongation: ECG and electrolyte monitoring is recommended per the approved prescribing information, particularly in patients with risk factors.

Haemorrhagic Events: Bleeding events, which can be serious, have been reported; monitoring for signs of bleeding is recommended.

Tumour Lysis Syndrome: Rare but reported, particularly in patients with high disease burden; adequate hydration and monitoring is recommended.

Hypersensitivity Reactions: Reported, particularly during the first month of treatment, presenting with fever, rash, or joint/muscle pain.

Risk of Impaired Wound Healing: Retevmo should be stopped at least 7 days before planned surgery, per the approved prescribing information.

Full side effect information is available at FDA Selpercatinib Safety Information.


Precautions

  • Hepatotoxicity — regular liver function monitoring required per approved schedule
  • Interstitial lung disease/pneumonitis — prompt evaluation of new respiratory symptoms recommended
  • Hypertension — blood pressure optimisation required before starting; regular monitoring throughout treatment
  • QT prolongation — ECG and electrolyte monitoring recommended
  • Haemorrhagic events — monitor for signs of bleeding
  • Tumour lysis syndrome — adequate hydration and monitoring, particularly in high disease burden
  • Wound healing — discontinue at least 7 days before planned surgery; do not resume until adequate healing
  • Hypothyroidism — thyroid function monitoring recommended
  • Hip joint problems in children — monitor for hip or knee pain, or limp, in paediatric patients
  • Companion diagnostic testing — mandatory before initiating therapy to confirm RET alteration status
  • Pregnancy — can cause fetal harm; effective contraception recommended during and after treatment, per the approved label
  • Refer to manufacturer prescribing information and NCCN oncology guidelines for complete management context

Storage and Handling

  • Store at 20°C to 25°C, with excursions permitted between 15°C and 30°C, per manufacturer specification
  • Keep in original packaging — protect from moisture
  • Keep out of reach of children

As a responsible medicine distributor in Delhi, A.K. Pharma stores all oncology medicines including Retevmo under manufacturer-recommended conditions ensuring product integrity for every supply.


Manufacturer Information

Retevmo (Selpercatinib) is manufactured by Eli Lilly and Company, originally developed by Loxo Oncology. Selpercatinib received its first FDA approval in May 2020 as a RET kinase inhibitor across multiple RET-altered cancer types. As Retevmo does not currently hold routine commercial availability in India, hospitals and patients typically access it through a Named Patient Program import pathway. A.K. Pharma supplies only genuine Retevmo sourced from authorised distributors. Learn more about Eli Lilly’s oncology portfolio directly from the manufacturer.


Related Oncology and Biomarker-Directed Medicines Available at A.K. Pharma


Frequently Asked Questions

Q. What is Retevmo used for?
Retevmo (Selpercatinib) is used to treat RET fusion-positive metastatic non-small cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer, in patients whose tumours have a confirmed RET alteration.

Q. What is the generic name and strength of Retevmo?
The generic name of Retevmo is Selpercatinib, supplied as 40mg and 80mg capsules, manufactured by Eli Lilly and Company.

Q. Why is RET alteration testing required before starting Retevmo?
Retevmo is approved specifically for tumours with a confirmed RET gene fusion or mutation, which drives a distinct molecular subtype of cancer. Testing confirms whether a patient’s tumour carries this alteration before treatment is considered.

Q. Is Retevmo commercially available in India?
Retevmo does not currently hold routine commercial availability in India and is typically accessed through a Named Patient Program import pathway with a valid prescription from a qualified oncologist. A.K. Pharma can support hospitals and patients through this process.

Q. What is the price of Retevmo in India?
Retevmo pricing depends on the import pathway, quantity, and applicable documentation. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current guidance on availability and pricing.

Q. How to access Retevmo through A.K. Pharma?
Contact A.K. Pharma directly to discuss Named Patient Program access, required documentation, and current import timelines for Retevmo.

Q. Does A.K. Pharma support hospital-level procurement of Retevmo?
Yes. A.K. Pharma supports hospitals and oncology centres in accessing Retevmo through appropriate import channels across Delhi and India.


Why Work With A.K. Pharma for Retevmo Access

  • Licensed medicine distributor in Delhi and pharmaceutical distributor in Delhi with all required drug licenses
  • Support navigating Named Patient Program import pathways for medicines not yet commercially available in India
  • 100% genuine Retevmo sourced from authorised distributors
  • Available alongside companion biomarker-directed oncology medicines — Rahika, Spexib, Koselugo, Truqap, Tishtha — simplifying procurement
  • Prompt response to all quote and access requests
  • Serving oncologists across Delhi NCR and India

Contact A.K. Pharma for Retevmo Access Support

📍 E-2/257A, 2nd Floor, Shastri Nagar, New Delhi 110052
📞 011 4172 6999
📱 WhatsApp: +91 9810034827
🌐 akpharma.in


Disclaimer: This page is intended for informational and sourcing/procurement purposes only and does not constitute medical or clinical advice. All treatment decisions, including drug selection and dosing, should be made by a qualified healthcare professional in accordance with the approved prescribing information. A.K. Pharma is a licensed medicine distributor and does not provide clinical guidance.

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