FDA record · Cancer
What FDA's own documents say about Emrelis: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.
“EMRELIS is a c-Met-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [>=50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.”
Prescribing Information (Label) · PDF p. 2 · fda.gov ↗
| Trial | ClinicalTrials.gov | Phase | Mentions | Documents |
|---|---|---|---|---|
| EAS-1 | not given | 7 | 1 of 11 |
Mentions: how many sentences across the FDA documents name the trial. NCT ids are read from the documents or, where they give none, matched on ClinicalTrials.gov by the trial's name or protocol code.
Sentences from FDA's reviews that give an endpoint's p-value, effect or confidence interval, those reporting a treatment effect first.
PFS
“A significant positive correlation between efficacy variables and CavgC1 ADC (PFS per ICR, OS, and DoR) and CmingmADC (PFS per ICR and OS only) was observed (p < 0.05) across the evaluated range of exposures.”
Multi-disciplinary Review · PDF p. 73 · fda.gov ↗
p < 0.05
“The most common adverse reactions (>=20%) were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema.”
Prescribing Information (Label) · PDF p. 2 · fda.gov ↗
“• The recommended dosage of EMRELIS is 1.9 mg/kg administered intravenously every 2 weeks until disease progression or unacceptable toxicity.”
Prescribing Information (Label) · PDF p. 2 · fda.gov ↗
| Document | Date | Pages | Copy | sha256 |
|---|---|---|---|---|
| Prescribing information, original approval761384s000lbl.pdf | May 15, 2025 | 20 | fffe931ab10c | |
| Approval letter761384Orig1s000ltr.pdf | May 23, 2025 | 10 | c32023939e2b | |
| Administrative Correspondence761384Orig1s000AdminCorres.pdf | June 16, 2025 | 58 | cacf6c3511ee | |
| Approval Letter761384Orig1s000Approv.pdf | June 16, 2025 | 13 | 778e306ba2ad | |
| Chemistry Review761384Orig1s000ChemR.pdf | June 16, 2025 | 32 | 13247473335f | |
| Prescribing Information (Label)761384Orig1s000Lbl.pdf | June 16, 2025 | 22 | 12d0abf2067d | |
| Multi-disciplinary Review761384Orig1s000MultidisciplineR.pdf | June 16, 2025 | 251 | archived copy | 2f706bfb5340 |
| Proprietary Name Review761384Orig1s000NameR.pdf | June 16, 2025 | 10 | 98f2303959b8 | |
| Officer/Employee List761384Orig1s000OEList.pdf | June 16, 2025 | 3 | 1dd770fda799 | |
| Other Reviews761384Orig1s000OtherR.pdf | June 16, 2025 | 37 | e0be0896fbf7 | |
| Risk Assessment / REMS Review761384Orig1s000RiskR.pdf | June 16, 2025 | 15 | 4ab65e92dc55 |
Checked against FDA's copies on September 30, 2026. The sha256 is the fingerprint of the file that was read: download it from fda.gov and compare. Quotes come from the text of each file as read; pages FDA stored as images were read by OCR and are marked.
Generated automatically (auto): the trials, names and dates are drafted from the documents by rules, with no language model; see the method.