Avmapki Fakzynja Co-Pack access in Saudi Arabia: the SFDA named-patient pathway
How patients in the Kingdom of Saudi Arabia legally obtain Avmapki Fakzynja Co-Pack (avutometinib and defactinib co-pack) when the locally registered indication, stocked presentation, or payer coverage does not match what the prescribing physician has written.
Last reviewed 2026-05-12 by Reserve Meds clinical and regulatory team.
Quick orientation
Patients in Saudi Arabia access Avmapki Fakzynja Co-Pack (avutometinib and defactinib co-pack) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy through the SFDA named-patient pathway, a Saudi Food and Drug Authority-administered mechanism that allows a Saudi-licensed physician at a registered facility to import the FDA-labelled product for a specific named patient. This page details the documentation, approval timeline, and real cost in SAR.
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How Avmapki Fakzynja Co-Pack reaches patients in Saudi Arabia
Avmapki Fakzynja Co-Pack (avutometinib paired with defactinib, a fixed co-pack from Verastem Oncology) received US FDA accelerated approval in May 2025 for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy per the FDA label record at accessdata.fda.gov/scripts/cder/daf. Avutometinib is a RAF and MEK clamp that inhibits MEK1/2 phosphorylation and the RAF-MEK complex; defactinib is a focal adhesion kinase inhibitor; the dual blockade was designed to overcome the adaptive resistance that has limited MEK-monotherapy in KRAS-driven low-grade serous ovarian cancer per the published mechanism work in pre-clinical and clinical publications indexed on PubMed at pubmed.ncbi.nlm.nih.gov. The Saudi Food and Drug Authority registered-drug list at sfda.gov.sa/en/drugs-list shows no public registration record for avutometinib, defactinib, or the Avmapki Fakzynja Co-Pack as of 2026-06-01. Saudi patients access the co-pack through the SFDA Special Access Programme for unregistered drugs administered by the treating institution, with the hospital-led import filing the typical mechanism for first-of-kind targeted oncology cases, per SFDA news at sfda.gov.sa/en/news and the Lexology Saudi Arabia life-sciences law review at lexology.com. The Personal Importation pathway under SFDA Drug-6567E at sfda.gov.sa Drug-6567E remains available for patient-initiated cases. The treating Saudi-licensed gynaecologic oncologist issues a medical report (approved by the treatment institution and dated within 6 months prior to submission per the SFDA hard requirement) documenting tissue-confirmed low-grade serous ovarian cancer with KRAS mutation status from next-generation sequencing, the prior systemic therapy history (platinum-based chemotherapy, hormonal agents, prior MEK inhibitors), and the planned dosing of avutometinib 3.2 mg orally twice weekly with defactinib 200 mg orally twice daily on a 21-days-on, 7-days-off schedule referencing the RAMP-201 trial at clinicaltrials.gov/NCT04625270. SFDA does not publish a fixed processing-time SLA.
Where Avmapki Fakzynja Co-Pack is dispensed in Saudi Arabia
Avmapki Fakzynja Co-Pack is an oral targeted-therapy combination given in the outpatient gynaecologic-oncology setting with serial imaging response assessment (RECIST 1.1 CT or MRI every 6 to 9 weeks), CA-125 trending, full blood count, liver function, creatine kinase, ophthalmology baseline and serial surveillance (MEK inhibitors carry retinal-toxicity signals), and dermatologic monitoring. The Saudi tertiary centres with gynaecologic-oncology and molecular tumour-board infrastructure include King Faisal Specialist Hospital and Research Centre (KFSHRC) Department of Obstetrics and Gynaecology and the Cancer Centre of Excellence in Riyadh and Jeddah at kfshrc.edu.sa Cancer Centre of Excellence, which treats approximately one-quarter of Saudi cancer cases annually; King Fahad Medical City (KFMC) Comprehensive Cancer Center at kfmc.med.sa; King Abdulaziz Medical City (KAMC, NGHA) Princess Noorah Oncology Center in Riyadh and Jeddah at ngha.med.sa; Prince Sultan Military Medical City Oncology Department in Riyadh at psmmc.med.sa; and King Fahad Specialist Hospital Dammam Oncology and BMT service at kfsh.med.sa. KFSHRC and KFMC are the most frequent dispensing nodes for first-of-kind targeted-oncology Special Access cases because of their molecular-pathology capacity and gynaecologic-oncology surgical-medical multidisciplinary boards.
What Avmapki Fakzynja Co-Pack costs in Saudi Arabia
The US wholesale acquisition cost for the Avmapki Fakzynja Co-Pack is reported by Verastem Oncology at approximately USD 25,000 to USD 28,000 per 28-day co-pack at the labelled dose, with annual drug-only spend in the range of USD 270,000 to USD 305,000 per year for continuous-on-treatment patients per manufacturer disclosure tracked on Drugs@FDA at accessdata.fda.gov/scripts/cder/daf. Price snapshot: 2026-06-01. The Saudi Riyal is pegged to the US dollar at approximately 3.75 SAR to 1 USD per the Saudi Central Bank reference rate at sama.gov.sa. No SFDA-published SAR maximum retail price for Avmapki Fakzynja Co-Pack is observed on the SFDA channel at sfda.gov.sa as of 2026-06-01; do not estimate. Cost layers beyond the drug include ambient logistics (the co-pack contains oral tablets and does not require cold chain), the SFDA permit and customs duties, the dispensing facility administration fees, the serial imaging and biomarker workup costs, and the Reserve Meds concierge fee itemised separately on every firm quote.
Funding and access barriers for Avmapki Fakzynja Co-Pack in Saudi Arabia
Gynaecologic-oncology specialty therapy funding in Saudi Arabia for Saudi nationals is delivered at MOH-affiliated specialty centres (KFSHRC, KFMC, KAMC, Prince Sultan Military Medical City) under public funding via NUPCO procurement at nupco.com, with the case proceeding through institutional formulary review and the SFDA Special Access route for unregistered targeted therapies. Saudi nationals typically face no direct charge for in-network specialty oncology drugs delivered at MOH centres. For non-citizens (expatriates), the Cooperative Health Insurance scheme regulated by the Council of Health Insurance at chi.gov.sa defines the Essential Benefits Package as the floor; coverage of unregistered oncology drugs like avutometinib plus defactinib on retail and corporate policies is case by case and typically requires documented KRAS mutation status, low-grade serous ovarian cancer histology, prior systemic therapy failure, and gynaecologic-oncology specialist sign-off. Major insurers (Bupa Arabia, Tawuniya, MedGulf, AXA Cooperative) often require pre-authorisation with documented response on initial cycles before continuation approval. The King Salman Humanitarian Aid and Relief Centre (KSrelief) at ksrelief.org funds high-cost case-by-case treatment for defined humanitarian non-citizen populations. The biomarker workup (KRAS NGS confirmation) is the binding clinical step; KFSHRC and KFMC molecular-pathology services handle this in-house.
Recent regulatory and access news for Avmapki Fakzynja Co-Pack
The FDA accelerated approval of Avmapki Fakzynja Co-Pack in May 2025 was based on the RAMP-201 single-arm trial overall response rate and duration-of-response data; the FDA approval letter and supporting clinical review documents are catalogued on the FDA Oncology Center of Excellence channel at fda.gov/about-fda/oncology-center-excellence. The European Medicines Agency has not authorised the combination in the EU as of 2026-06-01 per the EMA medicines portal at ema.europa.eu/en/medicines, which constrains the reference-authority options Saudi gynaecologic oncologists can cite to the FDA listing. Verastem Oncology has reported the confirmatory RAMP-301 phase 3 trial at clinicaltrials.gov/NCT06072781 enrolling in 2025 with global sites including Middle East participation under discussion, which would further support reference-authority status in the EU and beyond. The SFDA continued its Drug Sector electronic-services modernisation per SFDA news at sfda.gov.sa/en/news, and the SFDA Hajj 1446E annual clearance regulations remain the Hajj-season medicine-travel reference. No drug-specific SFDA bulletin for avutometinib, defactinib, or the Avmapki Fakzynja Co-Pack over the last 12 months has been observed as of 2026-06-01.
Where Reserve Meds fits in Avmapki Fakzynja Co-Pack cases
Reserve Meds is a US-based concierge coordinator. We do not replace your treating physician, we do not replace SFDA, and we do not replace your dispensing pharmacy. For Avmapki Fakzynja Co-Pack specifically, we orchestrate the US-side sourcing through a DSCSA-compliant specialty channel, build the documentation packet your physician submits, coordinate validated logistics (cold-chain with continuous temperature logging where the FDA label requires it) into Saudi Arabia, and assign a single named coordinator through the case. Standard named-patient coordination under our specialty playbook applies. Presentation selection, dose-band confirmation, and patient onboarding for self-administration where applicable are the recurring operational fundamentals we expect for this drug.
Operationally, a typical Avmapki Fakzynja Co-Pack case runs across four parallel tracks. The clinical track is the physician's: justification letter, dosing plan, monitoring schedule, and the next patient-facing follow-up. The regulatory track is the SFDA application packaged by the importer; we provide the documentation template, the dispensing facility license check, and the chain-of-custody attestation. The logistics track is the US-side sourcing and the validated international shipment with continuous temperature logging and customs broker coordination. The patient-experience track is the named coordinator who keeps everyone aligned on dates, addresses dispensing-pharmacy questions, and confirms the medicine has been received and stored correctly. The four tracks are run in parallel rather than in series; that is the operational difference between a 3-week and a 9-week case.
Saudi tertiary specialty care concentrates at KFSH&RC Riyadh and Jeddah, KAMC, and KSUMC; the SFDA personal-import authorisation is the standard mechanism for unregistered specialty medicines and is filed by the treating consultant at one of these centres.
Next step
If your Saudi physician has prescribed Avmapki Fakzynja Co-Pack and you are weighing the cross-border route, the next step is a short intake. We confirm eligibility within 24 to 48 hours and send a documentation kit to your physician.
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