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Fulzerasib

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Fulzerasib

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Fulzerasib
Generic Name (API): Fulzerasib
Dosage Form & Strength: 150 mg
Route: Oral
Drug Class: KRAS G12C inhibitor (covalent, irreversible)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Fulzerasib Used For?

Fulzerasib is a targeted tablet for advanced non-small cell lung cancer (NSCLC) that carries a specific gene change called KRAS G12C. It was discovered by GenFleet Therapeutics in Shanghai and is sold in China by Innovent Biologics as 达伯特® (Dupert®). It was the first medicine of its kind to be approved in China.

China's National Medical Products Administration (NMPA) granted it conditional approval in August 2024, through priority review, for adults with:

  • Advanced non-small cell lung cancer with a KRAS G12C mutation
  • Who have already received at least one systemic treatment, such as chemotherapy or immunotherapy

The mutation must be confirmed by a validated test before treatment starts. It is a prescription lung cancer medicine and should only be used under an oncologist.

How It Works

KRAS is a protein that acts like an on/off switch for cell growth. In the G12C mutation, the switch gets stuck in the "on" position and keeps telling cancer cells to divide. Fulzerasib binds permanently to the faulty KRAS G12C protein and locks it in its "off" state. This shuts down the growth signals and can make the cancer cells stop dividing and die.

Because it targets one exact mutation, it only helps people whose tumour carries KRAS G12C. That is why gene testing of the tumour, or sometimes of a blood sample, comes first.

What the Trial Showed

The approval was based on a phase 2 registration study in China, published in the Journal of Thoracic Oncology in 2024. It included 116 adults with KRAS G12C lung cancer whose disease had grown after standard treatment; most (84.5%) had already had both immunotherapy and platinum chemotherapy, and 30.2% had brain metastases.

  • About half (49.1%) saw their tumours shrink, as judged by an independent review panel
  • The disease was brought under control in 90.5% of patients
  • Median time before the cancer grew again was 9.7 months
  • Median overall survival was 13.3 months, and 54.4% were alive at one year (Chinese label data)

This is a conditional approval based on a single-arm study. Full approval depends on a confirmatory trial.

Recommended Dosage

  • 600 mg twice a day (four 150 mg tablets per dose), about 12 hours apart
  • Can be taken on an empty stomach or after food, at the same times each day
  • Swallow the tablets whole; do not chew, crush or split them
  • Continued for as long as it is working and side effects are manageable

If a dose is missed by more than 4 hours, skip it and take the next one on time. If you vomit after a dose, do not take an extra one. For side effects, the oncologist may pause treatment or lower the dose to 450 mg twice a day, and then to 750 mg once a day.

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Warnings and Precautions

Liver effects: raised liver enzymes are common. ALT went up in 28.2% and AST in 27.6% of patients in the combined safety data, mostly at grade 1 to 2. Liver tests (ALT, AST and bilirubin) are checked before starting, every 3 weeks for the first 3 months, and then monthly. The dose is paused, lowered or stopped depending on the result.

  • Anaemia: the most common side effect, seen in 47.5% of patients, and severe (grade 3 or more) in 9.0%. Blood counts are checked on the same schedule as liver tests.
  • Lung inflammation: non-infectious pneumonitis or interstitial lung disease occurred in 4.0% of patients, often with no symptoms. Report new or worse breathlessness, cough or fever straight away. It is stopped for good if a severe reaction is confirmed.
  • Other common effects: raised bilirubin (25.2%), protein in the urine (24.6%), tiredness (24.3%), low blood albumin (23.9%), itching (23.3%) and swelling (22.9%).
  • Stomach acid medicines: proton pump inhibitors cut the level of fulzerasib in the blood by about two-thirds, so the label says to avoid using them together. Strong P-gp inhibitors should also be avoided.
  • Other interactions: it moderately slows a liver enzyme called CYP2D6, so some other medicines may need extra care. Give your oncologist a full list of everything you take.
  • Pregnancy and breastfeeding: it may harm an unborn baby and is not recommended in pregnancy. Use effective contraception during treatment. Do not breastfeed during treatment and for 1 week after the last dose.

Overall: in 301 people who took the recommended dose, serious side effects occurred in 14.0%. 32.6% needed a pause in treatment and 18.3% a lower dose, but only 2.7% stopped because of side effects. Safety in children has not been established.

How to Access Fulzerasib in India: A 6-Step Process

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.

Documentation & Availability

What documents are required to import Fulzerasib to India?

The tablets can be imported only in the patient's name, by the patient or a government hospital, in line with India's import regulations for unapproved medicines. You will need:

  • A valid prescription from a qualified medical oncologist
  • Diagnostic reports confirming non-small cell lung cancer, a molecular test report showing the KRAS G12C mutation, and details of previous treatment
  • Patient ID proof (issued by the Government of India)

How is the order confirmed?

Once we have received and checked a valid prescription and, where needed, an import permit.

Is Fulzerasib available in India?

No. It is approved only in China. It has no CDSCO approval, it is not sold in Indian pharmacies, and the US FDA and European Medicines Agency have not approved it either.

Patients can still get it legally through the Named Patient Program (NPP), which allows a medicine not registered in India to be imported for one specific patient on a prescription. If testing shows a different driver mutation, see our pages on Hernexeos for HER2-mutant lung cancer and Ibtrozi for ROS1-positive lung cancer.

It can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others — and can facilitate delivery to the patient's treating hospital. Orders are confirmed only after receipt of a valid doctor's prescription and an import permit, where applicable.

Sourcing & Delivery

NamedPatientProgram.com (NPP) sources this medicine through the manufacturer's authorised supply channels in China and arranges supply to patients, doctors, and hospitals under applicable legal provisions. Each bottle holds 112 tablets of 150 mg, which lasts 14 days at the full dose of eight tablets a day, so a month of treatment needs about two bottles. The label says to keep the bottle sealed, in its original pack and below 30°C, and the tablets travel that way under temperature-controlled shipping. All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.

For the current cost in India and availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.

Availability Across Major Cities in India

Patients across India can access this medicine through regulated import pathways, with delivery arranged to the patient or the treating hospital on a valid oncologist's prescription.

Delhi

Thoracic oncology teams in Delhi treat lung cancer patients from across North India, and our New Delhi dispatch point means refills can arrive without a break in treatment.

Mumbai

Oncologists in Mumbai can request the tablets for a named patient once the KRAS G12C report and prescription are shared.

Bangalore

Patients in Bangalore can have each two-week bottle delivered to their home or to the hospital pharmacy.

Chennai

A major centre for cancer care in South India, where molecular testing of lung tumours is widely available.

Hyderabad

We plan supply bottle by bottle so patients in Hyderabad do not run short between oncology reviews.

Kolkata

Patients in Kolkata and the eastern states can use the same documented import route, with the quote shared before anything is ordered.

Pune

Oncologists in Pune can send us the prescription and test results to start the process.

Ahmedabad

Patients across Gujarat can receive the tablets through their treating cancer hospital in Ahmedabad.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the patient or the treating oncologist.

Jaipur

Patients in Rajasthan can continue treatment at home, with refills planned around their liver and blood test visits.

Lucknow

We coordinate delivery for patients treated at public and private cancer hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can have the tablets delivered in Kochi and nearby cities, with updates at every stage.

Access can also be coordinated for patients in other Indian cities, subject to a valid prescription and regulatory requirements.

Author Details

Nitin Goswami

Written By

Nitin Goswami

Deputy Manager – Content & Social Media, Ikris Pharma Network

Sources: NMPA • CDSCO

Dr. Chirag C Shah

Medically Reviewed By

Dr. Chirag C Shah

MBBS

Last Updated: 19 October 2026

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