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Lazcluze (lazertinib) is a third-generation oral EGFR tyrosine kinase inhibitor used together with the bispecific antibody Rybrevant (amivantamab) as a chemotherapy-free first-line treatment for EGFR-mutated advanced lung cancer.
Lazcluze, combined with Rybrevant, is FDA-approved as first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
Lazertinib selectively inhibits mutant EGFR while sparing wild-type EGFR, blocking the abnormal signaling that drives tumor growth; combined with amivantamab, which targets both EGFR and MET, the regimen addresses multiple resistance pathways.
The recommended dose of Lazcluze is 240 mg orally once daily, combined with amivantamab dosed by body weight on a defined weekly-then-biweekly IV schedule, until disease progression or unacceptable toxicity, as determined by the treating oncologist.
Lazcluze, used in combination with Rybrevant, requires monitoring for several important safety considerations.
Serious and fatal venous thromboembolic events, including deep vein thrombosis and pulmonary embolism, can occur, most often within the first 4 months of treatment. Anticoagulant prophylaxis is typically recommended during this period.
Monitor for new or worsening respiratory symptoms; interrupt or discontinue treatment as needed.
Severe skin rash and nail toxicity can occur, sometimes requiring dose modification.
Monitor for visual changes and refer to ophthalmology as needed.
Associated with the amivantamab component; monitor closely during and after infusion.
Lazcluze can cause fetal harm. Effective contraception is required during treatment and for 3 weeks after the final dose.
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.
Lazcluze (lazertinib) received FDA approval in August 2024, combined with Rybrevant (amivantamab), and is manufactured by Janssen Biotech.
Import of Lazcluze through a Named Patient Program requires a valid prescription from the treating oncologist, confirmation of EGFR exon 19 deletion or exon 21 L858R mutation status via an FDA-approved test, and supporting clinical documentation as required by Indian regulatory authorities.
NPP sources Lazcluze directly from Janssen's authorized supply chain to ensure product authenticity and regulatory compliance.
Lazcluze is sourced through verified, GDP-compliant channels from Janssen's authorized supply chain to ensure authenticity and quality.
Lazcluze tablets 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).
Once sourced, Lazcluze 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 Lazcluze through NPP's regulated import pathway, with oncology specialists in major cities supporting the treatment process.
Leading oncology centers in Mumbai support EGFR mutation testing and treatment coordination for Lazcluze access.
Delhi's major cancer hospitals assist patients with molecular testing and prescription support for Lazcluze.
Bangalore's oncology network offers access to EGFR testing and treatment planning for eligible NSCLC patients.
Chennai-based specialists coordinate Lazcluze access alongside comprehensive lung cancer care.
Hyderabad's cancer care institutions support patients pursuing Lazcluze therapy following confirmed EGFR mutation status.
Kolkata's oncology centers help coordinate documentation and treatment access for Lazcluze.
Pune-based oncologists assist with EGFR mutation testing and Lazcluze treatment planning.
Ahmedabad's specialty hospitals support the import and treatment process for Lazcluze.
Kochi's oncology units assist patients with the documentation needed for Lazcluze access.
Chandigarh's cancer care centers support Lazcluze treatment coordination for patients from North India.
Jaipur's oncology specialists help patients navigate the Lazcluze access process.
Lucknow-based cancer centers assist patients pursuing Lazcluze therapy.
Bhubaneswar's oncology institutions support access to Lazcluze for eligible patients.
Guwahati's specialists help coordinate Lazcluze access for patients across the Northeast.
Patients in other cities across India can also access Lazcluze through NPP's nationwide coordination network.
Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 10 September 2026
Sources: FDA • CDSCO
Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 10 September 2026
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