Advanced cancer therapies: evidence, approvals and access across countries.
Track selected regulatory decisions, understand the evidence behind them, and distinguish approval from real-world access. Our summaries link to primary sources and state what remains unverified.
We do not assess individual eligibility, review medical records or arrange treatment.
Where are you right now?
Three common situations. Pick the one that fits — it leads to the relevant evidence.
Recent decisions, organized by cancer type
This selection includes new approvals, indication expansions and CHMP recommendations. These are different regulatory events. It is not a complete register of cancer-drug decisions.
Approved for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring an NRG1 gene fusion with disease progression on or after prior systemic therapy .
Approved for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, with disease progression following at least one line of endocrine therapy .
Approved for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received 1–3 prior regimens, at least one including bevacizumab .
Accelerated approval for an expanded indication in adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test .
CHMP positive opinion — not an EC marketing authorisation — for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy .
Approved for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy .
Approved via priority review for adults with CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma who have failed at least two prior lines of therapy .
Approved for adults with relapsed or refractory large B-cell lymphoma after at least two prior systemic therapies, including DLBCL NOS, grade 3b follicular lymphoma, and high-grade B-cell lymphoma .
Approved as a Class 1 innovative drug for adults with ALK-positive locally advanced or metastatic NSCLC who have not received prior ALK inhibitor therapy .
Approved in Singapore for adults with multiple myeloma. Approval date: 18 June 2026 .
Approval, recommendation, investigation, and access are different things
A technology can have both approved and investigational uses. Do not assign one status to all CAR-T therapies, all vaccines or all immunotherapies.
This is a general educational framework, not a complete list. "Approved" means approved by at least one major regulator (FDA, EMA, NMPA, PMDA, HSA) for at least one indication. Approval in one country does not mean approval or availability everywhere.
Same drug, different approval status across countries
Different jurisdictions may reach decisions at different times and for different patient populations. Compare the exact product, indication, evidence, event type and date — not a general national treatment philosophy. See full access guides →
- Zenocutuzumab NRG1+ cholangiocarcinoma · May 2026
- Vepdegestrant ESR1-mutated breast cancer · May 2026
- Relacorilant + nab-paclitaxel Platinum-resistant ovarian · Mar 2026
- Zongertinib HER2 TKD NSCLC (expanded) · Feb 2026
- Daraxonrasib Metastatic pancreatic · Aug 2026
- Daraxonrasib Metastatic pancreatic · CHMP positive Oct 2026 (not yet EC approval)
- 舒瑞基奥仑赛 CLDN18.2 CAR-T, gastric/GEJ · Jun 2026
- 泊基奥仑赛 CAR-T, large B-cell lymphoma · Nov 2026
- 康特替尼 ALK+ NSCLC · Jun 2026
- Equecabtagene autoleucel (FUCASO) BCMA CAR-T · Jun 2026
China vs. United States: how the two systems differ
These differences explain why the same drug may be approved at different times, or for different indications, in each country. Each row compares a distinct layer — regulatory pathway, clinical guideline, disease focus, or cost — not a general national philosophy.
| Layer | United States (FDA / NCCN) | China (NMPA / CSCO) | What this means for patients |
|---|---|---|---|
| Regulatory pathway | FDA and NMPA use different accelerated-approval routes. FDA has priority review, breakthrough therapy and accelerated approval — the latter requires confirmatory trials. Timing of individual decisions varies by product and evidence package. | NMPA has expanded priority review and conditional approval since 2015 reforms. Conditional approval allows earlier market entry based on Phase II or surrogate endpoints, with confirmatory obligations . | A drug may be approved in one country years before the other — or approved in one and never submitted in the other. Approval timing alone does not indicate which regulator reviewed the evidence more rigorously. |
| Clinical guideline | NCCN guidelines: evidence-graded, regularly updated, widely used as a global reference standard. | CSCO guidelines: explicitly integrate international evidence with local epidemiology, drug availability and cost — “立足中国、兼顾国际” . | Your physician’s guideline may recommend a drug that is approved in another country but not yours, or vice versa. Guideline recommendation is not the same as regulatory approval or access. |
| Disease burden focus | Research investment concentrates on cancers with high US incidence — breast, prostate, lung adenocarcinoma, colorectal. | Research investment concentrates on cancers with high Chinese incidence — esophageal squamous, nasopharyngeal, gastric, HBV-related liver cancer . | If your cancer type is rare in one country, clinical trial data may be concentrated elsewhere. This is a structural difference, not a judgment about quality of care. |
| Cost and access | High list prices; insurance coverage varies by plan; patient out-of-pocket costs can be substantial even for approved drugs. | Lower list prices for domestic drugs; national reimbursement negotiations; access varies by region and hospital tier. | A drug approved in both countries may be affordable in one and not the other. Regulatory approval never guarantees access. |
Sources: CSCO vs NCCN guideline comparison (2025); CACA integrative oncology framework; NMPA approval pathway description; China–US cancer burden differences. For FDA positions, see FDA Oncology Approval Notifications.
Five questions worth asking your oncologist
Based on how recent approvals are structured — most require biomarker testing and a clear prior-treatment history. Tap a question to expand the explanation.
Does my tumor have a biomarker that matches any approved therapy?
Is the treatment I read about a standard option or only available in a clinical trial?
If it is approved, is it approved for my cancer type and stage — or a different one?
What is the goal of this treatment — cure, control, or symptom relief?
If this does not work, what is the next evidence-based option?
From the founder
Reza Abdollahi
I built CancerCareE so that patients and families could see a clear picture of their options before any decision — without pressure, without promises, and with information they can review together with their physician. That is why we compare more than one country, and why every card links to a primary source.