{"id":59163,"date":"2024-04-06T04:02:20","date_gmt":"2024-04-06T02:02:20","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/enhertu-fam-trastuzumab-deruxtecan-nxki-approved-in-the-us-as-first-tumor-agnostic-her2-directed-therapy-for-previously-treated-patients-with-metastatic-her2-positive-solid-tumors\/"},"modified":"2024-04-06T04:02:20","modified_gmt":"2024-04-06T02:02:20","slug":"enhertu-fam-trastuzumab-deruxtecan-nxki-approved-in-the-us-as-first-tumor-agnostic-her2-directed-therapy-for-previously-treated-patients-with-metastatic-her2-positive-solid-tumors","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/enhertu-fam-trastuzumab-deruxtecan-nxki-approved-in-the-us-as-first-tumor-agnostic-her2-directed-therapy-for-previously-treated-patients-with-metastatic-her2-positive-solid-tumors\/","title":{"rendered":"ENHERTU\u00ae (fam-trastuzumab deruxtecan-nxki) approved in the US as first tumor-agnostic HER2-directed therapy for previously treated patients with metastatic HER2-positive solid tumors"},"content":{"rendered":"
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\nBased on three Phase II trials of AstraZeneca and Daiichi Sankyo\u2019s <\/i>ENHERTU which showed clinically meaningful responses across a broad range of tumors<\/i><\/b><\/p>\n

\nENHERTU now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers<\/i><\/b><\/p>\n

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Daiichi Sankyo’s ENHERTU\u00ae<\/sup> (fam-trastuzumab deruxtecan-nxki) <\/i>has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.<\/p>\n

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\nThis indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.<\/p>\n

\nENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.<\/p>\n

\nThe first tumor-agnostic approval of a HER2-directed therapy and ADC by the Food and Drug Administration (FDA) was based on results from the subgroup of patients with HER2-positive IHC 3+ tumors in each of the DESTINY-PanTumor02<\/a>, DESTINY-Lung01<\/a> and DESTINY-CRC02<\/a> Phase II trials.<\/p>\n

\nFunda Meric-Bernstam, MD, Chair of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, US, said: \u201cUntil the approval of fam-trastuzumab deruxtecan-nxki, patients with metastatic HER2-positive solid tumors have had limited treatment options. Based on the clinically meaningful response rates seen across clinical trials, this tumor-agnostic approval means that patients may now be treated with a HER2-directed medicine.\u201d<\/p>\n

\nDave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: \u201cAs the first antibody drug conjugate to be granted a tumor-agnostic indication, ENHERTU is truly delivering on its potential across metastatic HER2-targetable tumors. The approval also elevates the importance of testing for biomarkers, including HER2, across a broad range of tumors to ensure these patients with advanced cancer who have few options know whether a targeted medicine might be right for them.\u201d<\/p>\n

\nKen Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc., said: \u201cThis fifth indication in the US is a significant milestone as eligible patients with previously treated metastatic HER2-positive solid tumors may now be treated with ENHERTU. The accelerated approval by the FDA for this tumor-agnostic indication is based on the clinically meaningful efficacy seen with ENHERTU across numerous types of metastatic cancers.\u201d<\/p>\n

\nIn the DESTINY-PanTumor02 Phase II trial, patients with centrally or locally assessed HER2-positive (IHC 3+) solid tumors including either biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumors treated with ENHERTU <\/i>showed a confirmed ORR of 51.4% (95% confidence interval [CI]: 41.7-61.0) and a median DoR range of 19.4 months (range: 1.3-27.9+ [+ denotes ongoing responses at data cutoff]). In DESTINY-Lung01, patients with centrally confirmed HER2-positive (IHC 3+) non-small cell lung cancer (NSCLC) treated with ENHERTU <\/i>showed a <\/i>confirmed ORR of 52.9% (95% CI: 27.8-77.0) and median DoR range of 6.9 months (range: 4.0-11.7+). A confirmed ORR of 46.9% (95% CI: 34.3-59.8) and median DoR range of 5.5 months (range: 1.3+-9.7+) was seen in patients with centrally confirmed HER2-positive (IHC 3+) colorectal cancer in the DESTINY-CRC02 trial.<\/p>\n

\nThe safety of ENHERTU was evaluated in 347 patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors in the DESTINY-Breast01, DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. The safety profile observed across the trials was consistent with previous clinical trials of ENHERTU with no new safety concerns identified.<\/p>\n

\nBased on these results, fam-trastuzumab deruxtecan-nxki (ENHERTU) has been included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines\u00ae<\/sup>) as a treatment option for multiple metastatic tumors. See NCCN Guidelines\u00ae<\/sup> for detailed recommendations.1<\/sup><\/p>\n

\nThis approval was granted under the FDA\u2019s Real-Time Oncology Review program after securing Priority Review<\/a> and Breakthrough Therapy Designation for ENHERTU in the US in this setting.<\/p>\n

\nThe US regulatory submission was reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. As part of Project Orbis, ENHERTU is also under regulatory review for the same indication by regulatory authorities in Australia, Brazil and Singapore.<\/p>\n

\nImportant Safety Information<\/b><\/p>\n

\nIndications
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<\/b>ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:<\/p>\n