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Manufacturer / Innovator:
USA
Regulatory Approval:
N/A
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Rozlytrek (entrectinib) is a kinase inhibitor approved by the FDA for two indications: treatment of adults with ROS1-positive metastatic non-small cell lung cancer (NSCLC), and treatment of adult and pediatric patients (1 month and older) with solid tumors harboring an NTRK gene fusion, without a known acquired resistance mutation, who are metastatic or where surgery is likely to cause severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed after treatment.
Rozlytrek inhibits the ROS1 and TRK (tropomyosin receptor kinase) proteins, blocking abnormal signaling driven by ROS1 rearrangements or NTRK gene fusions that fuel tumor growth in these genetically defined cancers.
Rozlytrek is intended for patients whose tumors have been confirmed through an FDA-approved test to carry a ROS1 rearrangement (for NSCLC) or an NTRK gene fusion (for various solid tumor types), across a wide age range for the NTRK indication.
The recommended adult dose of Rozlytrek is 600 mg orally once daily. Pediatric dosing is based on body surface area, using capsules or oral pellets as appropriate.
Rozlytrek does not carry a formal FDA boxed warning. However, patients and prescribers should be aware of the following important safety information.
Left ventricular ejection fraction should be assessed before starting treatment and monitored during therapy, as congestive heart failure has been reported.
Cognitive impairment, mood disorders, dizziness, and sleep disturbances have been reported. Patients should be advised about these potential effects, particularly when driving or operating machinery.
An increased risk of fractures has been observed. Patients should be evaluated for signs and symptoms of fractures, and imaging performed if clinically indicated.
Liver function tests should be monitored every 2 weeks during the first month of treatment, then periodically thereafter.
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.
Rozlytrek is manufactured and marketed by Genentech USA, Inc., a member of the Roche Group. It is sourced through authorized distribution channels for patients seeking named-patient import into India.
Patients typically need a valid prescription from a treating oncologist confirming diagnosis and ROS1 or NTRK biomarker testing results. NPP's regulatory team assists in preparing and verifying the documentation needed for a compliant import.
As an FDA-approved therapy for ROS1-positive NSCLC and NTRK fusion-positive solid tumors, Rozlytrek is sourced through authorized channels and imported under GDP-compliant logistics to preserve product quality throughout transit.
NPP sources Rozlytrek directly from authorized pharmaceutical distributors to ensure product authenticity and full traceability. Every shipment is handled under Good Distribution Practice (GDP) conditions from origin to the patient's doorstep.
Rozlytrek should be stored at 20°C to 25°C, with excursions permitted between 15°C and 30°C, and this condition is maintained throughout transit.
Once documentation and regulatory approvals are in place, delivery timelines are communicated transparently at the time of quotation, accounting for import clearance and last-mile logistics to the patient's city.
Patients across India can access Rozlytrek through NPP's regulated import pathway, with oncology specialists in major cities supporting the treatment process.
Leading hospitals in Mumbai support oncology care coordination and documentation for Rozlytrek access.
Delhi's major hospitals assist patients with prescription support and documentation for Rozlytrek.
Bangalore's specialist network offers access coordination for eligible cancer patients seeking Rozlytrek.
Chennai-based oncology specialists coordinate Rozlytrek access alongside comprehensive biomarker-driven cancer care.
Hyderabad's care institutions support patients pursuing Rozlytrek therapy.
Kolkata's specialist centers help coordinate documentation and treatment access for Rozlytrek.
Pune-based specialists assist with prescription support and Rozlytrek treatment planning.
Ahmedabad's specialty hospitals support the import and treatment process for Rozlytrek.
Kochi's specialist units assist patients with the documentation needed for Rozlytrek access.
Chandigarh's care centers support Rozlytrek treatment coordination for patients from North India.
Jaipur's specialists help patients navigate the Rozlytrek access process.
Lucknow-based centers assist patients pursuing Rozlytrek therapy.
Bhubaneswar's institutions support access to Rozlytrek for eligible patients.
Guwahati's specialists help coordinate Rozlytrek access for patients across the Northeast.
Patients in other cities across India can also access Rozlytrek through NPP's nationwide coordination network.
Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 15 September 2026
Sources: FDA
Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 15 September 2026
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