Tagrisso® (Osimertinib) — Third Generation EGFR Inhibitor for Non-Small Cell Lung Cancer

Advanced Targeted Therapy for EGFR-Mutated Lung Cancer

Tagrisso® (Osimertinib) is a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI) used to treat non-small cell lung cancer (NSCLC) with EGFR mutations. It is approved as a first-line treatment for EGFR-mutated NSCLC and for patients with T790M mutation-positive NSCLC after progression on prior EGFR TKI therapy. Tagrisso is also approved as adjuvant therapy after tumour resection in EGFR-mutated early-stage NSCLC.

A.K. Pharma is a trusted medicine distributor in Delhi supplying genuine Tagrisso (Osimertinib) to hospitals, oncology centres, clinics, and pharmacies across India. Manufactured by AstraZeneca, a leading global oncology pharmaceutical company, Tagrisso is one of the most important medicines in the treatment of lung cancer globally.

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What is Tagrisso (Osimertinib)?

Tagrisso contains Osimertinib, a third-generation EGFR tyrosine kinase inhibitor that selectively and irreversibly inhibits both EGFR-sensitising mutations (Ex19del and L858R) and the T790M resistance mutation. Unlike first and second-generation EGFR TKIs, Tagrisso also crosses the blood-brain barrier effectively, making it particularly useful in patients with brain metastases.

EGFR (Epidermal Growth Factor Receptor) mutations are found in approximately 10-15% of Caucasian and 30-40% of Asian NSCLC patients. Tagrisso is indicated for patients whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations, confirmed by an FDA-approved or validated test.

Full prescribing information is available at the FDA label for Osimertinib.

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Clinical Studies and Evidence

FLAURA Trial (Tagrisso as First-Line Treatment for EGFR-Mutated NSCLC) Published in the New England Journal of Medicine (2018), the FLAURA trial demonstrated that Tagrisso significantly improved progression-free survival (PFS) compared to standard EGFR TKIs (gefitinib or erlotinib) as first-line treatment, with a median PFS of 18.9 months vs 10.2 months.

FLAURA2 Trial (Tagrisso + Chemotherapy for First-Line EGFR-Mutated NSCLC) Published in the New England Journal of Medicine (2023), the FLAURA2 trial showed that Tagrisso combined with platinum-based chemotherapy significantly improved PFS compared to Tagrisso alone, with a median PFS of 25.5 months vs 16.7 months, establishing a new standard of care option.

ADAURA Trial (Tagrisso as Adjuvant Therapy for Early-Stage NSCLC) Published in the New England Journal of Medicine (2020), the ADAURA trial demonstrated that adjuvant Tagrisso significantly improved disease-free survival in patients with stage IB, II, and IIIA EGFR-mutated NSCLC after complete tumour resection, with an 83% reduction in the risk of disease recurrence or death compared to placebo in stage II-IIIA patients.

AURA3 Trial (Tagrisso for T790M-Positive NSCLC) The AURA3 trial showed Tagrisso achieved a progression-free survival of 10.1 months vs 4.4 months for platinum-based chemotherapy in patients with T790M mutation-positive NSCLC who had progressed on prior EGFR TKI therapy.

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Available Strengths

Tagrisso is available in the following strengths:

• 40mg Film-coated Tablets
• 80mg Film-coated Tablets

The recommended dose is 80mg once daily. The 40mg strength is used for dose reduction in cases of adverse reactions. Tagrisso can be taken with or without food and should be taken at the same time each day.

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Indications — What Tagrisso is Used For

First-Line Treatment

• Metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations
• Can be used as monotherapy or in combination with platinum-based chemotherapy

Second-Line Treatment

• Metastatic T790M mutation-positive NSCLC in patients who have progressed on or after EGFR TKI therapy

Adjuvant Therapy

• Adjuvant treatment of adults with stage IB, II, and IIIA NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations after complete tumour resection

For detailed indication information refer to the NCI Osimertinib Drug Information.

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Key Benefits of Tagrisso

Superior Progression-Free Survival Tagrisso has demonstrated superior PFS compared to first and second-generation EGFR TKIs in multiple Phase 3 trials, establishing it as the preferred first-line treatment for EGFR-mutated NSCLC.

CNS Activity — Crosses the Blood-Brain Barrier Unlike earlier generation EGFR TKIs, Tagrisso effectively crosses the blood-brain barrier, making it particularly valuable in patients with brain metastases, which occur in up to 25-40% of NSCLC patients.

T790M Resistance Mutation Coverage Tagrisso is the only approved treatment for T790M mutation-positive NSCLC — the most common resistance mechanism to first and second-generation EGFR TKIs — offering an effective option after disease progression.

Adjuvant Use After Surgery Tagrisso is the first EGFR TKI approved for adjuvant use after curative resection, significantly reducing the risk of disease recurrence in early-stage EGFR-mutated NSCLC.

Once Daily Oral Treatment Tagrisso’s once-daily oral administration offers convenience and maintains quality of life compared to intravenous chemotherapy.

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How Tagrisso Works

EGFR mutations in NSCLC cause the EGFR protein to be permanently activated, continuously driving cancer cell growth and division. Tagrisso works by:

• Irreversibly binding to and inhibiting mutated EGFR including Ex19del and L858R sensitising mutations
• Blocking the T790M resistance mutation that develops after treatment with first and second-generation EGFR TKIs
• Penetrating the blood-brain barrier to treat CNS metastases
• Inhibiting downstream signalling pathways including PI3K/AKT and RAS/MAPK that drive cancer cell proliferation

For a detailed explanation of Osimertinib’s mechanism, refer to the American Society of Clinical Oncology guidelines.

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Dosage and Administration

• Recommended Dose: 80mg orally once daily
• Dose Reduction: 40mg once daily for adverse reactions
• Administration: With or without food, at approximately the same time each day
• Duration: Until disease progression or unacceptable toxicity
• Missed Dose: Take as soon as remembered on the same day — do not take two doses on the same day
• Tablets: Swallow whole — do not crush or chew. If difficulty swallowing, tablets may be dispersed in water

Full dosing guidelines available at Drugs.com Osimertinib Dosage.

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Who Should Use Tagrisso

Tagrisso is prescribed for:

• Adult patients with metastatic NSCLC confirmed to have EGFR exon 19 deletion or exon 21 L858R mutation
• Patients with T790M mutation-positive NSCLC who have progressed on prior EGFR TKI therapy
• Patients with stage IB, II, or IIIA EGFR-mutated NSCLC who have undergone complete tumour resection
• Patients with NSCLC and brain metastases requiring CNS-active EGFR inhibition

EGFR mutation testing is required before initiating Tagrisso therapy. Testing can be performed on tumour tissue or circulating tumour DNA (liquid biopsy). Tagrisso is prescribed by oncologists and pulmonologists specialising in thoracic cancers. A.K. Pharma supplies Tagrisso to hospitals, cancer centres, and pharmacies across Delhi and India.

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Possible Side Effects

Common side effects include diarrhoea, rash, dry skin, nail toxicity (paronychia), stomatitis, and fatigue.

Serious side effects include:

• Interstitial lung disease (ILD) or pneumonitis — discontinue immediately if suspected
• QTc interval prolongation — monitor ECG in patients at risk
• Cardiomyopathy — monitor cardiac function before and during treatment
• Keratitis — refer to ophthalmologist if eye symptoms develop
• Severe skin reactions including Stevens-Johnson syndrome

Full side effect information available at FDA Osimertinib Safety Information.

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Precautions

• EGFR mutation testing is required before initiating therapy
• Monitor for signs of ILD/pneumonitis throughout treatment
• Perform ECG and electrolyte monitoring in patients at risk of QTc prolongation
• Monitor left ventricular ejection fraction (LVEF) before and during treatment
• Avoid concomitant use of strong CYP3A inducers (e.g. rifampicin, phenytoin, carbamazepine)
• Not recommended during pregnancy — women of childbearing potential should use effective contraception
• Men with female partners of childbearing potential should use effective contraception during and for 4 months after treatment

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Storage and Handling

• Store at room temperature below 25°C
• Keep in original packaging — protect from moisture
• Keep out of reach of children
• Do not crush, chew, or split tablets unless dispersing in water for patients with swallowing difficulty

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

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Manufacturer Information

Tagrisso (Osimertinib) is manufactured by AstraZeneca, a global biopharmaceutical company focused on oncology, cardiovascular, and respiratory medicines. Tagrisso received initial FDA approval in November 2015 for T790M mutation-positive NSCLC, with subsequent approvals for first-line treatment and adjuvant use. A.K. Pharma supplies only genuine Tagrisso sourced from authorized distributors.

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Related Cancer Medicines Available at A.K. Pharma

• Imfinzi 120mg (Durvalumab) — PD-L1 inhibitor for lung cancer — another AstraZeneca product
• Imjudo (Tremelimumab) — used in combination with Imfinzi for lung cancer
• Enhertu (Trastuzumab Deruxtecan) — HER2-targeted therapy for lung cancer
• Ramiven (Ramucirumab) — VEGFR-2 inhibitor for lung cancer
• Browse all Cancer Medicines available at A.K. Pharma

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Frequently Asked Questions

Q. What is Tagrisso used for? Tagrisso (Osimertinib) is used to treat EGFR-mutated non-small cell lung cancer (NSCLC) as first-line treatment, as second-line treatment for T790M-positive NSCLC, and as adjuvant therapy after tumour resection. More information is available at Cancer.gov.

Q. What is the generic name of Tagrisso? The generic name of Tagrisso is Osimertinib. It belongs to the third-generation EGFR tyrosine kinase inhibitor class of targeted cancer therapies.

Q. Is Tagrisso available in India? Tagrisso can be supplied to hospitals, oncology centres, clinics, and pharmacies in India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi — for availability and pricing.

Q. What EGFR mutations does Tagrisso target? Tagrisso targets EGFR exon 19 deletions, exon 21 L858R sensitising mutations, and the T790M resistance mutation. EGFR mutation testing is required before starting treatment.

Q. Does Tagrisso work for brain metastases? Yes. Unlike first and second-generation EGFR TKIs, Tagrisso effectively crosses the blood-brain barrier and has demonstrated significant activity against CNS metastases in clinical trials.

Q. What is the price of Tagrisso in India? Tagrisso price in India varies by strength and pack size. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.

Q. How to order Tagrisso from A.K. Pharma? You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827 with your requirements and we will respond promptly.

Q. Does A.K. Pharma supply Tagrisso in bulk? Yes. A.K. Pharma supplies Tagrisso in bulk to hospitals, oncology centres, and pharmacies across Delhi and India. Contact us for bulk pricing and availability.

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Why Order Tagrisso from A.K. Pharma?

• Licensed medicine distributor in Delhi with all required drug licenses
• 100% genuine Tagrisso sourced from authorized AstraZeneca distributors
• Reliable supply to oncology centres, hospitals, and pharmacies across India
• Bulk supply available with competitive pricing
• Prompt response to all quote requests
• Serving oncologists across Delhi NCR and all major cities in India

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