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Is Enhertu approved for gastric cancer?
- Thread starter ginfreely
- Start date
The Food and Drug Administration (FDA) has granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
The approval was based on data from 3 clinical trials: DESTINY-PanTumor02 (ClinicalTrials.gov Identifier: NCT04482309), DESTINY-Lung01 (ClinicalTrials.gov Identifier: NCT03505710), and DESTINY-CRC02 (ClinicalTrials.gov Identifier: NCT04744831). The study population included 192 adults with previously treated unresectable or metastatic HER2-positive (IHC3+) solid tumors. The primary endpoint was confirmed objective response rate (ORR).
DESTINY-PanTumor02 included 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors. DESTINY-Lung01 and DESTINY-CRC02 included patients with non-small cell lung cancer and colorectal cancer, respectively.
The following efficacy results were reported across the 3 trials:
DESTINY-PanTumor02 included 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors. DESTINY-Lung01 and DESTINY-CRC02 included patients with non-small cell lung cancer and colorectal cancer, respectively.
The following efficacy results were reported across the 3 trials:
- DESTINY-PanTumor02: ORR was 51.4% (95% CI, 41.7-61.0); median duration of response (DOR) was 19.4 months (range 1.3, 27.9+).
- DESTINY-Lung01: ORR was 52.9% (95% CI, 27.8-77.0); median DOR was 6.9 months (range 4.0, 11.7+).
- DESTINY-CRC02: ORR was 46.9% (95% CI, 34.3-59.8); DOR was 5.5 months (range 1.3+, 9.7+).
Continued approval of this tumor agnostic indication is contingent upon verification of clinical benefit in a confirmatory trial.
References:
US Food and Drug Administration. FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors. April 5, 2024. https://www.fda.gov/drugs/resources...ruxtecan-nxki-unresectable-or-metastatic-her2.
References:
US Food and Drug Administration. FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors. April 5, 2024. https://www.fda.gov/drugs/resources...ruxtecan-nxki-unresectable-or-metastatic-her2.
You should just fly to Congo and look for the breast sucking pastor. I'm sure he can suck out your cancer from your hole, then seal it and make you a new hymen.
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