In Turkey, medicines from abroad are supplied through TEB or the SGK İbn-i Sina depot. Ask us how the route works.Ask about Hyrnuo

Is Hyrnuo available in Turkey? Status, route and cost

A plain answer for families in Turkey, 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 Turkey?

We have not checked whether sevabertinib, the active substance in Hyrnuo, is licensed in Turkey or on TİTCK's Foreign Medicines List. Hyrnuo is a twice-daily tablet for HER2-mutant non-squamous lung cancer. Under TİTCK's guideline, the treating physician applies, and the Turkish Pharmacists' Association or the SGK İbn-i Sina depot imports it.

Registration: Not checked by us; your physician can check TİTCK's Foreign Medicines List.
Access route: Physician application to TİTCK if needed; import by TEB or the SGK İbn-i Sina depot.
Who acts: the treating physician applies to TİTCK if needed; TEB or the SGK İbn-i Sina depot imports the medicine.
Timeline: We give you a written timeline estimate for your case before you commit.
Price: Set through the TEB or SGK İbn-i Sina route in Turkey. Reserve Meds does not sell this medicine in Turkey.

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)
TİTCK's guideline names TEB and the SGK İbn-i Sina depot as the importers of medicines brought from abroad, with FDA or EMA licensed products supplied first. (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 Turkey

Under the guideline, these medicines are imported only by the Turkish Pharmacists' Association (TEB) and the İbn-i Sina depot of the Social Security Institution (SGK). A product licensed and marketed by the FDA or the EMA is supplied first.

If the active substance is already on TİTCK's Foreign Medicines List (Yurt Dışı İlaç Listesi), a separate TİTCK import permit is not normally needed for each prescription. If it is not on the list, TİTCK must approve it first. The application is signed and stamped by the physician who follows the patient; patients, relatives and pharmacists cannot fill in the forms. It includes the Foreign Medicine Use Request Form, a health board report or medicine use report, an informed consent form signed by the patient, strong scientific literature for this use, and an epicrisis with past treatments, responses and recent laboratory results. TİTCK updates the list every Friday and does not answer applications separately in writing.

When SGK reimbursement is requested, TİTCK does not allow a foreign medicine for a disease that can be treated with a medicine approved in Turkey for that indication, unless the foreign medicine offers a clear advantage supported by scientific data. The doctor must also explain that the imported medicine has not gone through TİTCK's licensing and quality checks.

We have not checked TİTCK's licence records or the current Foreign Medicines List for this medicine. Your physician or hospital pharmacy can check the list on TİTCK's website before applying.

Who does what

Your treating physician decides whether Hyrnuo is right for the patient and signs the TİTCK application, which patients and relatives cannot fill in.
TİTCK approves the active substance if it is not yet on the Foreign Medicines List, and can review reimbursement requests.
TEB or the SGK İbn-i Sina depot imports the medicine and is responsible for distribution to the patient.
Bayer makes Hyrnuo and decides where it is supplied.
Reserve Meds explains the route and helps organize records in English. We do not import into Turkey and 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
The Foreign Medicine Use Request Form (Ek-2), a health board report or medicine use report, and the informed consent form (Ek-3) signed by the patient
An epicrisis listing past treatments, responses and recent laboratory results

Steps

Check the list. Your physician or hospital pharmacy checks whether sevabertinib is on TİTCK's Foreign Medicines List.
Application if needed. If it is not, the physician sends the request form, the health board or medicine use report, the signed consent form, literature and the epicrisis to TİTCK.
List update. TİTCK publishes approved substances in its list, which it updates every Friday.
Import. TEB or the SGK İbn-i Sina depot imports the medicine on the prescription.
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. TİTCK updates its Foreign Medicines List every Friday; applications are not answered separately in writing.

In Turkey, the price of a medicine imported by TEB or the SGK İbn-i Sina depot is set through that route, and SGK reimbursement depends on TİTCK's decision. If you ask us to help with records, any coordination fee is quoted in writing 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. Under TİTCK's guideline, medicines brought into Turkey from abroad are imported by TEB or the SGK İbn-i Sina depot, so Reserve Meds does not ship Hyrnuo into Turkey. We can explain the route, help your family organize medical records in English, and share the US prescribing information your physician may cite. We do not prescribe, and we do not decide what TİTCK approves.

Ask about Hyrnuo in Turkey

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 Turkey?

We have not checked TİTCK's licence records or the current Foreign Medicines List for this medicine. Your physician or hospital pharmacy can check the list on TİTCK's website before applying.

How do patients in Turkey get Hyrnuo?

In Turkey, a medicine that is not licensed, or is licensed but not on the market, can be brought from abroad on a prescription basis under TİTCK's guideline on supplying and using medicines from abroad (Yurt Dışından İlaç Temini ve Kullanımı Kılavuzu). The guideline is meant for exceptional cases, for patients who have used all the treatment options available in Turkey or cannot use them. Under the guideline, these medicines are imported only by the Turkish Pharmacists' Association (TEB) and the İbn-i Sina depot of the Social Security Institution (SGK). A product licensed and marketed by the FDA or the EMA is supplied first.

How long does it take to get Hyrnuo in Turkey?

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. TİTCK updates its Foreign Medicines List every Friday; applications are not answered separately in writing.

How much does Hyrnuo cost?

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.