Drug

Mirvetuximab soravtansine

As of the edition of 20 October 2026, Mirvetuximab soravtansine is an antibody drug conjugate: marketed, first approved in 2022 (US); acts on FOLR1; US protection ends in 2034.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2025
Kind
Antibody drug conjugate
Brand name
Elahere
First approved
14 November 2022 (US)
Approvals on record
3 in 3 regions
Holder of the most recent approval
AbbVie; 3 holders in all
Registered trials
28, 2 stopped early
Disease areas
Cancer; Pregnancy and women's health; Urinary and reproductive; Hormones; Skin and connective tissue; Digestive system

US protection

US protection ends in 2034.

US protection ends in 2034, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by ImmunoGen. The date is computed, not published.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

2 listings count towards this date. The exact date and each listing are in the product.

See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.

Companies that need a new molecule because of this drug

1 company on route B because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Mirvetuximab soravtansine.

Target

GeneProteinUniProt
FOLR1Folate receptor alphaP15328

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated1010
Phase 15401
Phase 2173131
Phase 35310
All trials28

Who has held its approvals

CompanyRoleYears
ImmunoGenOriginator and Lead sponsor of trials2012 to now
AbbVieApplicant and Lead sponsor of trials2019 to now