Rare oncology conditions: cross-border specialty drug access for international patients
Rare oncology
ICD-10: C00-D48
Quick orientation
Individually rare cancers, including specific sarcomas, neuroendocrine tumors, and molecularly-defined subtypes, collectively account for approximately 25 percent of all cancer diagnoses.
Typical age of onset. All ages; subtype-specific.
Severity tiers. Severity depends on histology, stage, and molecular profile.
Why specialty drugs for Rare oncology conditions are hard to access internationally
Targeted therapies for molecularly-defined rare cancers are often unregistered in markets without established testing infrastructure. Even where registered, the patient population may be too small to sustain local supply.
Treatments approved by the FDA
- Krazati (adagrasib) — FDA approval: 2022. Mechanism: KRAS G12C inhibitor. Route: Oral twice daily. US WAC ballpark: Approximately USD 230,000 per year. Country pricing: Saudi Arabia · Kuwait · Egypt · Jordan.
- Welireg (belzutifan) — FDA approval: 2021. Mechanism: HIF-2 alpha inhibitor for VHL-associated tumors and advanced RCC. Route: Oral once daily. US WAC ballpark: Approximately USD 250,000 per year. Country pricing: India · Oman.
- Augtyro (repotrectinib) — FDA approval: 2023. Mechanism: ROS1 and TRK inhibitor for ROS1-positive NSCLC and NTRK fusion tumors. Route: Oral once daily. US WAC ballpark: Approximately USD 260,000 per year. Country pricing: UAE · Saudi Arabia · Qatar · Kuwait · Egypt.
- Ojemda (tovorafenib) — FDA approval: 2024. Mechanism: Type II RAF inhibitor for pediatric low-grade glioma with BRAF alterations. Route: Oral once weekly. US WAC ballpark: Approximately USD 350,000 per year, weight-based. Country pricing: UAE · Saudi Arabia · India · Egypt.
- Itovebi (inavolisib) — FDA approval: 2024. Mechanism: PI3K alpha inhibitor for PIK3CA-mutated HR+ HER2- breast cancer. Route: Oral once daily. US WAC ballpark: Approximately USD 230,000 per year. Country pricing: UAE · India · Bahrain · Lebanon.
Cross-border pathways used for Rare oncology conditions
Most patients use one or more of the following regulatory pathways, depending on the destination country and the specific drug:
What your physician needs to know
- Confirm molecular profile guiding targeted therapy.
- Where local molecular profiling is unavailable, coordinate sample referral to qualified labs.
- Document prior systemic therapy.
- Oncologist with relevant disease-area experience co-manages.
- Watch for class-specific adverse events.
Common questions
How is molecular testing handled?
Where local testing is unavailable, samples can be referred to qualified labs internationally.
Are these drugs registered in my country?
Registration varies. We confirm by destination.
Can I combine targeted therapy with chemotherapy?
Some regimens combine; others are monotherapy. Your oncologist sets the protocol.
How long does shipment take?
Five to fifteen business days from prescription receipt.
What documents are required?
Oncologist's prescription, pathology including molecular profile, imaging, and treatment history.
Where Reserve Meds fits in
Reserve Meds is a cross-border specialty drug access platform. We support international patients whose prescribed FDA-approved medicine is not registered locally, is not reimbursed by their payer, or is otherwise unavailable through standard channels. For Rare oncology conditions, our role is to coordinate the regulatory pathway, source the medicine from a DSCSA-compliant US wholesaler, and arrange validated cold-chain or controlled-temperature shipment to the destination country.
We do not replace your treating physician. We do not bill insurance. We operate a cash-pay model, and we work alongside the clinical team that knows your case. Every prescription is reviewed by a US-licensed pharmacist before dispense, and a US-licensed physician reviews the supply request before shipment.
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