EMA Recommends Marketing Approval For AbbVie’s Mirvetuximab Soravtansine

EMA Recommends Marketing Approval For AbbVie’s Mirvetuximab Soravtansine

By, Admin 24 September 2024

EMA committee recommends marketing approval for AbbVie’s mirvetuximab soravtansine for the treatment of certain adult ovarian cancer

Overview

AbbVie announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of mirvetuximab soravtansine (Elahere) for the treatment of adult patients with folate receptor alpha (FRa)-positive, platinum-resistant and high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior treatment regimens. Patients with ovarian cancer are often diagnosed with late-stage disease, undergo surgery and are then primarily treated with platinum-based chemotherapy. Over time patients may become resistant to platinum-based treatment and will require another therapy. The CHMP's opinion is supported by results of the phase 3 MIRASOL clinical trial and the European Commission decision on this indication for mirvetuximab soravtansine is anticipated later this year.

Statement from the CSO: AbbVie

  • Following many years of development by the ImmunoGen team that is now part of AbbVie, we are hopeful to make mirvetuximab soravtansine available to eligible patients with ovarian cancer in the European Union.
  • This positive opinion recognizes the unmet need for certain patients with platinum-resistant ovarian cancer,"" said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie.

Elahere: FDA Approval

  • Elahere (mirvetuximab soravtansine-gynx) was granted full FDA approval in the United States in March 2024. 
  • Marketing authorization submissions for mirvetuximab soravtansine are under review in multiple other countries.

MIRASOL Trial

  • MIRASOL is a global phase 3 open-label, randomized, controlled trial that enrolled 453 patients to compare the efficacy and safety of mirvetuximab soravtansine with the investigator's choice of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan) in the treatment of platinum-resistant, high-grade serous ovarian cancer whose tumors express high levels of FRa (=75% of cells with =2+ staining intensity). 
  • Participants had previously received one to three lines of prior therapy. 
  • The primary endpoint was investigator-assessed progression-free survival (PFS). 
  • Key secondary endpoints included objective response rate (ORR) and overall survival (OS).

Ovarian Cancer: Epidemiology

  • Ovarian cancer is one of the leading causes of death from gynaecological cancers. 
  • According to the World Ovarian Cancer Coalition, in 2022 more than 320,000 women worldwide were diagnosed with ovarian cancer. 
  • By 2050 the annual incidence will have risen to nearly half a million, an increase of 55 per cent. 
  • Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. 
  • Unfortunately, the majority of patients eventually develop platinum-resistant disease, which is difficult to treat. 
  • In this setting, standard of care single-agent chemotherapies are associated with decreased efficacy and tolerability.

About Mirvetuximab Soravtansine

Mirvetuximab soravtansine is a first-in-class ADC comprising a folate receptor-alpha binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.

Not Approved: Mirvetuximab soravtansine is not approved in the EU.

Elahere: Indication

  • Elahere is indicated for the treatment of adult patients with folate receptor-alpha (FRa) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. 
  • Select patients for therapy based on an FDA-approved test.

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.

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