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Is Hyrnuo available in Pakistan? Status, route and cost

A plain answer for families in Pakistan, checked against FDA, regulator and manufacturer sources on 17 October 2026.

Reviewed by the Reserve Meds clinical operations team on 17 October 2026.

Is Hyrnuo available in Pakistan?

We have not checked Hyrnuo's registration with DRAP, Pakistan's regulator, so ask your oncologist or hospital to confirm it. Hyrnuo is a twice-daily tablet for HER2-mutant non-squamous lung cancer. When a doctor prescribes a medicine not registered in Pakistan, DRAP can issue a no objection certificate for personal-use import.

Registration: Not checked by us; ask your oncologist or hospital to confirm it with DRAP.
Access route: Personal-use import permission from DRAP, on a doctor's prescription.
Who acts: the patient or a blood relative applies to DRAP for a personal-use NOC, with the prescription of a registered medical practitioner; a hospital can instead apply for an institutional NOC.
Timeline: We give you a written timeline estimate for your case before you commit.
Price: Medicine price: quote on request. You get a written quote for your case before you commit.

Status, with dates

FDA accelerated approval for previously treated patients on 19 November 2025. (source)
FDA widened the indication to patients without prior systemic therapy on 9 September 2026. (source)
DRAP issues a no objection certificate (NOC) for personal-use import of medicines. (source)

What Hyrnuo is

Hyrnuo (sevabertinib) is a tablet made by Bayer. It is for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, found with an FDA-authorized test.

The FDA first approved it on 19 November 2025, under accelerated approval, for patients who had already received a systemic therapy. Accelerated approval was based on tumor response rate and how long responses lasted. On 9 September 2026 the FDA widened the indication so that it no longer requires prior systemic therapy. In the SOHO-01 trial, 75% of 69 patients who had not had systemic therapy had a confirmed tumor response, and 73% of those responses lasted at least 6 months.

How it is given and safety

The dose is 20 mg by mouth twice daily with food, until the cancer grows or side effects become unacceptable. It is a tablet, so after the prescription it can be taken at home under the oncologist's follow-up.

The FDA lists warnings for diarrhea, liver toxicity, lung inflammation (interstitial lung disease or pneumonitis), weaker heart pumping, eye problems, raised pancreatic enzymes and harm to an unborn baby. At the first approval, Bayer reported the most common side effects as diarrhea (87%), rash (66%), nail-fold infection (paronychia, 33%), mouth sores (stomatitis, 29%) and nausea (21%).

How access works in Pakistan

DRAP's checklist asks for a request to the Assistant Director (Import and Export) at DRAP, preferably from the patient or a blood relative; copies of the CNIC or passport of the applicant and the patient; contact numbers for both; and a prescription on the letterhead of a registered medical practitioner, signed and stamped. DRAP says personal-use applications are made on its online portal.

DRAP also issues NOCs to hospitals and institutions that import unregistered medicines. They apply at the nearest DRAP field office with the documents on DRAP's checklist. Narcotic, psychotropic and controlled medicines need extra approval from DRAP's Controlled Drugs Division.

We have not checked this medicine against DRAP's register. Ask your doctor or hospital to confirm its current status in Pakistan before anything is filed, and confirm the current NOC procedure with DRAP.

Who does what

Your treating doctor decides whether Hyrnuo is right for the patient and writes the prescription the application needs.
The patient or family applies to DRAP with the documents below, unless a hospital applies for an institutional permission instead.
The Drug Regulatory Authority of Pakistan (DRAP) decides whether to permit the import, and how much.
The hospital or clinic follows up the patient during treatment.
Reserve Meds helps you prepare the file, and where the import is permitted, arranges US supply through our licensed wholesale partner. We do not give medical advice.

Documents you will usually need

The tumor test report showing a HER2 (ERBB2) TKD activating mutation (the US label requires an FDA-authorized test; ask your oncologist how the local test compares)
Pathology confirming non-squamous NSCLC, and recent scans
A list of past cancer treatments, if any
Identity documents for the patient (and the applicant, if different), as the regulator asks
The prescription from a registered medical practitioner, with the doctor's registration number, the medicine, the quantity and the duration

Steps

Prescription. Your doctor writes the prescription and a short clinical summary for Hyrnuo.
Application. The patient or family sends the application and documents to DRAP.
Permission. DRAP reviews the file and issues its permission, or asks for more information.
US sourcing. Our US-licensed wholesale partner supplies the medicine, shipped with tracking.
Treatment. The patient starts treatment with the oncologist's follow-up.

Timeline and cost

We give you a written timeline estimate for your case before you commit. The regulator, the hospital and the manufacturer set their own timelines.

Medicine price: quote on request. You get a written quote for your case before you commit. Your total cost depends on the dose, shipping, import steps and coordination. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.

How Reserve Meds helps

Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We coordinate access to FDA-approved medicines only. We help your family understand the route, organize records and communication with the doctor and hospital, and, where an import is approved, arrange US supply and shipping through our licensed wholesale partner. Delivery follows the terms of the import approval and is confirmed in writing before you commit. We do not prescribe, and we do not decide what DRAP approves.

Ask about Hyrnuo in Pakistan

Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.

Frequently asked questions

Is Hyrnuo registered in Pakistan?

How do patients in Pakistan get Hyrnuo?

In Pakistan, the Drug Regulatory Authority of Pakistan (DRAP) issues a no objection certificate (NOC) for importing a medicine for personal use. The Government of Pakistan said in February 2018 that when a registered medical practitioner prescribes a medicine that is not registered in Pakistan, the patient can import it for personal use with DRAP's permission. DRAP's checklist asks for a request to the Assistant Director (Import and Export) at DRAP, preferably from the patient or a blood relative; copies of the CNIC or passport of the applicant and the patient; contact numbers for both; and a prescription on the letterhead of a registered medical practitioner, signed and stamped. DRAP says personal-use applications are made on its online portal.

How long does it take to get Hyrnuo in Pakistan?

We give you a written timeline estimate for your case before you commit. The regulator, the hospital and the manufacturer set their own timelines, and we tell you honestly what depends on them.

How much does Hyrnuo cost?

Medicine price: quote on request. You get a written quote for your case before you commit. Your total cost, including shipping, import steps and coordination, is quoted in writing before you commit. No hidden charges.

Who can take Hyrnuo?

On the US label, adults with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors carry a HER2 (ERBB2) tyrosine kinase domain activating mutation, found with an FDA-authorized test. Since September 2026, prior systemic therapy is no longer required. Your oncologist decides whether it fits your case.

Sources

Checked on 17 October 2026. Regulator rules and lists change. Your doctor, hospital pharmacy or the regulator confirms the current position before anything is filed.