Cancer medicines from the US: a practical guide for patients in the Gulf

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

Step 1: match the patient to the US label

Many targeted cancer medicines are approved for patients whose tumor has a specific marker, confirmed by an FDA-authorized test. FDA keeps a public list of authorized companion diagnostic tests.^{[1, 2]}

Some indications carry accelerated approval, meaning benefit was shown on response rate or another surrogate measure and is still being confirmed. The label says so, and the oncologist can explain what that means for the patient.^[3]

Recent US cancer approvals we cover

• Modeyso (dordaviprone): diffuse midline glioma with an H3 K27M mutation that has progressed after prior therapy, in patients 1 year and older (accelerated approval).^[4]
• Komzifti (ziftomenib): relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation in adults without satisfactory alternatives.^[5]
• Revuforj (revumenib): relapsed or refractory acute leukemia with a KMT2A translocation, confirmed by an FDA-authorized test, in patients 1 year and older, among other uses.^[6]
• Emrelis (telisotuzumab vedotin): advanced non-squamous non-small cell lung cancer with high c-Met protein overexpression, confirmed by an FDA-approved test.^[7]
• Bizengri (zenocutuzumab): advanced non-small cell lung cancer, pancreatic adenocarcinoma or cholangiocarcinoma with an NRG1 gene fusion after prior therapy (accelerated approval for some uses).^[8]
• Datroway (datopotamab deruxtecan): advanced EGFR-mutated non-small cell lung cancer after prior EGFR-directed therapy and platinum chemotherapy (accelerated approval), and certain metastatic breast cancers.^[9]
• Elrexfio (elranatamab): relapsed or refractory multiple myeloma after at least four prior lines of therapy (accelerated approval).^[10]
• Columvi (glofitamab): relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.^[11]
• Ojemda (tovorafenib): relapsed or refractory pediatric low-grade glioma with a BRAF fusion, rearrangement or V600 mutation, from 6 months of age (accelerated approval).^[12]

Step 2: the hospital request

In Saudi Arabia, the SFDA Special Access Program lets a patient with a serious or immediately life-threatening condition receive a medicine that is not registered when no comparable alternative exists. The request comes from the manufacturer or sponsor, or from the licensed treating physician if there is no sponsor. We give you a written timeline estimate for your case before you commit.^[13]

In Bahrain, NHRA Circular 41 of 2020 lets government and private hospitals import a non-registered medicine with the authority's permission before the purchase order, when the medicine is important and has no registered alternative in Bahrain, is registered with the Gulf Health Council, a GCC state or a reference regulator such as the US FDA, and is marketed in its country of origin.^[14]

Cancer medicines that are injected or infused, or that need medical supervision, are generally excluded from personal-use clearance in Saudi Arabia, so the hospital route is the right one.^[15]

Cell therapies such as CAR-T

CAR-T and other cell therapies are made for one patient and given at qualified centers. FDA's list of approved cellular and gene therapy products includes cancer cell therapies such as Carvykti and Abecma for multiple myeloma, Aucatzyl for B-cell acute lymphoblastic leukemia, Amtagvi for melanoma and Tecelra for synovial sarcoma.^{[16, 17, 18, 19, 20, 21]}

For these, the treating oncologist refers the patient to a center that offers the therapy, and the center confirms eligibility, funding and dates.

Why registration lags in the Gulf

FDA's Project Orbis lets cancer medicines be reviewed at the same time by partner regulators in Australia, Brazil, Canada, Israel, Singapore, Switzerland and the United Kingdom. No Gulf regulator is on that list, so Gulf registration depends on the manufacturer applying locally.^[22]

How Reserve Meds helps

Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help families and treating doctors understand the route, prepare the documents the regulator or hospital asks for, arrange supply from the US once approval is in place, and keep everyone updated. We do not diagnose, prescribe or decide what a regulator approves.

We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.

Sources for these answers: ^{[13, 15, 1]}

Related

• Companion diagnostics
• Project Orbis
• FDA accelerated approval
• Answers to common access questions
• Named-patient access, explained
• US expanded access (compassionate use)
• اقرأ هذه الصفحة بالعربية

This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.