Example scenario: a patient in Manama asks about a newer breast cancer medicine

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

The situation

A woman in Manama has HR-positive, HER2-negative breast cancer that has spread. She has already had endocrine (hormone) therapy and chemotherapy.

Her oncologist is considering Datroway (datopotamab deruxtecan-dlnk), an antibody-drug conjugate made by Daiichi Sankyo. The US FDA approved it on 17 January 2025 for adults with this type of breast cancer after endocrine therapy and chemotherapy. It is given as an infusion once every 3 weeks, dosed by body weight, and continues until the cancer progresses or side effects become too much.

Label update: the current US label for Datroway (DailyMed, effective 27 May 2026) also covers adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer after prior EGFR-directed therapy and platinum-based chemotherapy (an accelerated approval), and adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. Your oncologist confirms which use applies. Current US label (DailyMed)

The family asks: can the hospital in Bahrain give it, what does the hospital need, and how is a medicine given every 3 weeks kept in supply?

Why it is not simple

Datroway is not on the National Health Regulatory Authority (NHRA) Registered Medicine Price List (version dated 7 September 2026) or on its Temporary Importation Medicines List (dated 19 January 2025). We checked both on 17 October 2026.

So a hospital in Bahrain needs NHRA's permission before it can order it.

What happens, step by step

1. The oncologist decides.

   Only the treating oncologist decides whether Datroway is right for her. The oncologist writes a letter with the diagnosis, the tumor's hormone receptor and HER2 results, the treatments already given, and why this medicine is needed now.

2. The hospital checks NHRA's conditions.

   Under NHRA Circular No. (41) of 2020, government and private hospitals must get NHRA's permission before they issue a purchase order for a medicine that is not registered in Bahrain.

   The circular asks that the medicine is important and has no registered alternative in Bahrain, is registered with the Gulf Health Council or in a GCC country, is registered with a reference authority such as the US FDA, and is marketed in its country of origin. Medicines for rare diseases, emergencies and tumors with no registered alternative can be excused from some of these conditions, through NHRA's emergency medicines list or with Board approval. The hospital pharmacy checks each condition for this case.

3. The hospital applies by email.

   The request goes to NHRA by email with the application form, a Certificate of Pharmaceutical Product (CPP) or a registration certificate from a reference authority, and a Good Manufacturing Practice (GMP) certificate for the manufacturer.

   NHRA's 2022 application form is signed by the importing hospital, the agent or the marketing authorization holder, who takes full responsibility for the product's quality and safety. The CPP and GMP papers come from the manufacturer's side, so the hospital asks for them early.

4. NHRA decides.

   The circular does not state a processing time. If NHRA approves, the hospital can issue its purchase order.

5. Planning repeat supply.

   Because Datroway is given every 3 weeks, the hospital plans supply for a period of treatment, not one dose. The circular lets the requesting party ask for quantities to cover enough time, on the condition that the medicine is not sold or lent without NHRA's knowledge.

   The US label says the vials are stored in a refrigerator at 2 to 8 degrees Celsius and must not be frozen, so every shipment travels with temperature control. Reserve Meds arranges supply through our US-licensed pharmaceutical wholesale partner to the hospital pharmacy, never to the patient's home.

6. Treatment days and eye care.

   The first infusion takes 90 minutes, and she is watched for at least 1 hour after each of the first 2 infusions. The label asks for an eye examination when treatment starts and at the end, with eye checks every 3 cycles, preservative-free lubricating eye drops several times a day, and a steroid mouthwash to protect the mouth.

   The label also warns about lung inflammation (interstitial lung disease), which can be severe, so the oncology team watches for breathing symptoms.

Which time points are fixed

Regulators, manufacturers and hospitals set their own timelines, and most do not publish a fixed review time. We give you a written timeline estimate once we see the hospital file.

Documents usually needed

• A letter from the treating oncologist: diagnosis, receptor and HER2 results, past treatments and why Datroway is needed
• A prescription with the dose, based on body weight, and the planned treatment period
• Pathology reports
• NHRA's application form, completed and signed
• A Certificate of Pharmaceutical Product (CPP) or a reference authority registration certificate
• A Good Manufacturing Practice (GMP) certificate for the manufacturer
• The US prescribing information (we can supply this)

What it may cost

Quote on request. Because treatment continues every 3 weeks, the written quote covers the supply period the hospital plans. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.

What Reserve Meds does, and does not do

Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. Reserve Meds can explain the route, help the hospital gather the documents it needs from the supply side, arrange US supply through our wholesale partner after NHRA approval, coordinate cold-chain shipping for each delivery, and keep the family updated. We do not prescribe, and we do not decide what NHRA approves.

Related

• Datroway in Bahrain: access guide
• Datroway overview
• Bahrain country guide
• All example scenarios
• Our editorial standards
• اقرأ هذه الصفحة بالعربية

This page is general information, not medical advice. Your own doctor decides what is right for you.