Retevmo (anlotinib) is a small‑molecule, multi‑kinase inhibitor that blocks several receptors involved in tumor angiogenesis and growth (VEGFR, FGFR, PDGFR, c‑Kit, etc.).
| Region | Status | Key Information |
|--------|--------|-----------------|
| China | Approved | Retevmo received its first marketing approval in 2019 for treatment of advanced or metastatic non‑small‑cell lung cancer (NSCLC) that has progressed after two or more lines of systemic therapy. It is also approved for other solid tumors (e.g., soft‑tissue sarcoma, hepatocellular carcinoma) in later lines of treatment. |
| Japan | Approved | The Japanese drug approval agency (PMDA) granted approval in 2022 for the same indication as in China – advanced or metastatic NSCLC after at least two prior systemic therapies. |
| United States | Not FDA‑approved (as of July 2026) | Anlotinib has not yet received U.S. Food and Drug Administration approval for any indication. A New Drug Application (NDA) was submitted, but the FDA has not yet cleared the drug for commercial use. The company has sought orphan‑drug status for certain rare tumor indications, but no approval has been granted. |
| European Union | Not approved | No EMA marketing authorization has been issued. |
| Other countries | Limited approvals | Some countries in Southeast Asia and Latin America have granted approval based on the Chinese approval, but these are generally not part of the main regulatory pathways used in the U.S. or EU. |
Why the U.S. status matters
- Clinical use in the U.S. is currently limited to clinical trials. If you’re a patient or clinician looking for anlotinib, you’d need to enroll in a registered study or obtain the drug via compassionate-use programs, if available.
- Insurance coverage is not an issue in the U.S. because the drug isn’t yet marketed; coverage decisions are moot until approval.
Key points to remember
1. Retevmo is already in clinical use in China and Japan for advanced NSCLC and a few other solid tumors.
2. The U.S. FDA has not yet approved the drug; the drug developer is still awaiting a decision or is exploring alternative pathways (e.g., expanded access).
3. Orphan‑drug designation has been sought for certain rare tumor indications, but this designation alone does not equate to approval for clinical use.
4. Clinical evidence: The SELECT trial (Phase III, published 2021) demonstrated a median overall survival benefit of about 2.2 months over placebo in patients with advanced NSCLC after two prior therapies. This data underpins the approvals in China and Japan.
Bottom line
- If you’re in the U.S.: Retevmo is not yet approved or reimbursed. You could discuss clinical trials with your oncologist.
- If you’re in China, Japan, or another country with approvals: Retevmo is an approved treatment option for advanced NSCLC after at least two lines of therapy and for a few other tumor types, with dosing typically 8 mg orally once daily for 14 days on, 7 days off, repeated in 21‑day cycles (exact regimens can vary by local guidelines).
Feel free to let me know if you’d like details on dosing, side‑effect profiles, or the status of specific clinical trials in the U.S.