{"id":13590,"date":"2024-11-19T20:30:22","date_gmt":"2024-11-19T12:30:22","guid":{"rendered":"https:\/\/flcube.com\/?p=13590"},"modified":"2024-11-19T20:31:12","modified_gmt":"2024-11-19T12:31:12","slug":"abbvies-elahere-receives-ec-approval-for-fr%ce%b1-positive-ovarian-cancer-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=13590","title":{"rendered":"AbbVie’s Elahere Receives EC Approval for FR\u03b1-Positive Ovarian Cancer Treatment"},"content":{"rendered":"\n

US-based AbbVie (NYSE: ABBV<\/a>) has announced the European Commission (EC) approval for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FR\u03b1) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This approval marks Elahere as the first and only FR\u0251-directed ADC product approved in the European Union (EU), as well as Iceland, Liechtenstein, Norway, and Northern Ireland.<\/p>\n\n\n\n

Companion Diagnostic Test Approval<\/strong>
On the same day, Swiss pharmaceutical giant Roche (SWX: ROG<\/a>) announced receiving CE Mark approval in the region for its ENTANA FOLR1 (FOLR1-2.1) RxDx Assay. This immunohistochemistry (IHC) companion diagnostic (CDx) test is the first to be widely available in Europe, aiding in identifying epithelial ovarian cancer (EOC) patients who may be eligible for targeted treatment with Elahere.<\/p>\n\n\n\n

Elahere’s Development and Commercialization<\/strong>
Elahere, originally developed by ImmunoGen Inc., was acquired by China-based Huadong Medicine Co., Ltd (SHE: 000963<\/a>) for development and commercialization in Greater China in a deal worth up to USD 305 million in October 2020. The ADC was first approved for marketing in the United States in November 2022 and gained fast-track entry via Hainan’s medical pilot zone in July of last year, where a real-world study for the drug in platinum-resistant ovarian cancer was initiated. In August 2023, Japan\u2019s Takeda (TYO: 4502<\/a>) struck a licensing deal with ImmunoGen to develop and commercialize the ADC in Japan. AbbVie completed the US 10.2 billion acquisition of ImmunoGen in February this year, securing rights to the drug. <\/p>\n\n\n\n

Approval Basis and Study Results<\/strong>
The approvals of Elahere and its CDx are primarily based on positive results from the Phase III MIRASOL study, which enrolled patients aged 18 years and older with disease that had progressed while on or after one to three lines of previous therapy. Patient tumors had to express high levels of FR\u0251 (\u226575% of tumor cells with \u22652+ membrane intensity), assessed using the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. The primary endpoint was investigator-assessed progression-free survival (PFS), with key secondary endpoints including objective response rate (ORR) and overall survival (OS). The data demonstrated a 35% reduction in the risk of tumor progression or death and a 33% reduction in the risk of death in the patients treated in the Elahere arm compared with the investigator’s choice (IC) chemotherapy arm, representing significantly improved PFS and OS. Elahere also produced a good safety profile.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

US-based AbbVie (NYSE: ABBV) has announced the European Commission (EC) approval for its antibody drug…<\/p>\n","protected":false},"author":1,"featured_media":13591,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,22],"tags":[234,35,114,1860,853,15,887,939,345,1141],"class_list":["post-13590","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-medical-device","tag-abbvie","tag-adc-xdc","tag-huadong-medicine","tag-immunogen","tag-nyse-abbv","tag-product-approvals","tag-she-000963","tag-swx-rop","tag-takeda","tag-tyo-4502"],"yoast_head":"\nAbbVie's Elahere Receives EC Approval for FR\u03b1-Positive Ovarian Cancer Treatment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"US-based AbbVie (NYSE: ABBV) has announced the European Commission (EC) approval for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FR\u03b1) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. 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