FDA record · Cancer
What FDA's own documents say about Hernexeos: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.
“HERNEXEOS is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.”
Prescribing information, supplement 006 · PDF p. 1 · fda.gov ↗
| Trial | ClinicalTrials.gov | Phase | Mentions | Documents |
|---|---|---|---|---|
| LUNG-11479-0001 | NCT04886804 | 1 | 219 | 10 of 17 |
| Study 1479 | not given | 164 | 4 of 17 | |
| SAF-3 | not given | 106 | 1 of 17 | |
| SAF-1 | not given | 39 | 1 of 17 | |
| LUNG-2 | not given | 23 | 6 of 17 | |
| SAF-2 | not given | 14 | 1 of 17 |
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.
ORR
“Statistical significance was achieved with both doses for the test of ORR against the fixed benchmark of 30% (120 mg QD: confirmed ORR = 66.7%; 97.5% CI 53.8, 77.5; 95% CI 55.4, 76.3; p<0.0001; 240 mg QD: confirmed ORR = 78.9%; 97.5% CI 64.8, 88.4; 95% CI 66.7, 87.5; p<0.0001).”
Multi-disciplinary Review · PDF p. 148 · fda.gov ↗
66.7%97.5%95%p<0.000178.9%30%
ORR
“Statistical significance was achieved in the first step of hierarchical testing of ORR against the fixed benchmark of 25% (confirmed ORR: 41.9%, 95% CI 26.4, 59.2, 1-sided p = 0.0147), and in the second step of statistical testing (confirmed ORR in patients with mutations in exon 20 of HER2:”
Multi-disciplinary Review · PDF p. 150 · fda.gov ↗
41.9%95%p = 0.014725%
“• Most common adverse reactions (>= 20%) are diarrhea, rash, hepatotoxicity, fatigue, nausea, musculoskeletal pain, and upper respiratory tract infection.”
Prescribing information, supplement 006 · PDF p. 1 · fda.gov ↗
“The recommended dosage of HERNEXEOS is based on body weight:”
Prescribing information, supplement 006 · PDF p. 2 · fda.gov ↗
| Document | Date | Pages | Copy | sha256 |
|---|---|---|---|---|
| Prescribing information, original approval219042s000lbl.pdf | August 11, 2025 | 18 | 53e35491e7c8 | |
| Approval letter219042Orig1s000ltr.pdf | August 12, 2025 | 7 | 8f428c214b67 | |
| Administrative Correspondence219042Orig1s000AdminCorres.pdf | September 9, 2025 | 35 | e2215b9e2b72 | |
| Approval Letter219042Orig1s000Approv.pdf | September 9, 2025 | 10 | a13fb67b6c14 | |
| Chemistry Review219042Orig1s000ChemR.pdf | September 9, 2025 | 43 | ec26ba6bf88c | |
| Prescribing Information (Label)219042Orig1s000Lbl.pdf | September 9, 2025 | 23 | 75475cb08a4d | |
| Multi-disciplinary Review219042Orig1s000MultidisciplineR.pdf | September 9, 2025 | 367 | b2c0ff70ba1a | |
| Proprietary Name Review219042Orig1s000NameR.pdf | September 9, 2025 | 17 | e2f8b199fcea | |
| Officer/Employee List219042Orig1s000OEList.pdf | September 9, 2025 | 2 | 4913376ed154 | |
| Other Reviews219042Orig1s000OtherR.pdf | September 9, 2025 | 57 | ac08dfedd83a | |
| Risk Assessment / REMS Review219042Orig1s000RiskR.pdf | September 9, 2025 | 12 | 4406fdb50abe | |
| Prescribing information, supplement 001219042s001lbl.pdf | March 2, 2026 | 19 | 8dd109d88c87 | |
| Approval letter, supplement 001219042Orig1s001ltr.pdf | March 2, 2026 | 7 | ec54f07c2f2c | |
| Prescribing information, supplement 005219042s005lbl.pdf | August 4, 2026 | 19 | eeff6bc6e108 | |
| Prescribing information, supplement 006219042s006lbl.pdf | August 4, 2026 | 19 | eb5cd5db7494 | |
| Approval letter, supplement 005219042Orig1s005ltr.pdf | August 4, 2026 | 4 | 1d327090efa9 | |
| Approval letter, supplement 006219042Orig1s006ltr.pdf | August 4, 2026 | 4 | 60a9b7d18d84 |
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.