Therapy Areas: Oncology
AbbVie's ELAHERE receives full US FDA approval
25 March 2024 -

AbbVie (NYSE: ABBV), a United States-based pharmaceutical company, announced on Friday that it has received full approval from the US Food and Drug Administration (FDA) for its ELAHERE (mirvetuximab soravtansine-gynx) intended for the treatment of folate receptor alpha (FR-alpha)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies.

ELAHERE was first granted FDA accelerated approval in November 2022 and the conversion to full approval is based on data from the confirmatory Phase 3 MIRASOL trial. This trial compared ELAHERE to investigator's choice (IC) of chemotherapy in patients with platinum-resistant ovarian cancer (PROC) whose tumours express high levels of FR? and who have been treated with up to three prior therapies. The primary endpoint of MIRASOL was progression-free survival (PFS) by investigator assessment and key secondary endpoints included objective response rate (ORR) and overall survival (OS).

Roopal Thakkar, MD, senior vice president, chief medical officer, global therapeutics, AbbVie, said, 'The full FDA approval of ELAHERE for eligible patients with ovarian cancer represents the culmination of years of work by the ImmunoGen team. ELAHERE is the first and only antibody-drug conjugate (ADC) approved in the US for this difficult-to-treat malignancy.'