FDA awards cancer drug approvals to AbbVie and MSD

Jenna Philpott

Thu, May 15, 2025, 12:26 PM 2 min read

The US Food and Drug Administration (FDA) has approved 2 oncology drugs: MSD’s Welireg (belzutifan) and AbbVie’s Emrelis (telisotuzumab vedotin-tllv). The decisions, announced connected 14 May, grow some idiosyncratic companies’ oncology portfolios and people chiseled diligent populations.

MSD received FDA support to marketplace Welireg for the attraction of adults and children aged 12 years and older with locally advanced, unresectable, oregon metastatic pheochromocytoma oregon paraganglioma (PPGL).

Welireg is present the archetypal oral attraction enactment disposable for treatingPPGL. The uncommon information affects an estimated 2,000 patients annually successful the US and is associated with adrenal gland tumours that nutrient excess adrenaline. This support could correspond a “change to the attraction paradigm for eligible patients”, according to Camilo Jimenez, prof for the Department of endocrine neoplasia and hormonal disorders astatine the University of Texas MD Anderson Cancer Center.

The support was based connected the Phase II LITESPARK-015 survey (NCT04924075), which included 72 patients. The survey met its superior endpoint, showing an nonsubjective effect complaint (ORR) of 26%. Data connected secondary endpoints included a median duration of effect (DoR) of 20.4 months. Among patients connected antihypertensive medicine astatine baseline, 32% saw a sustained simplification successful astatine slightest 1 drug.

Welireg was archetypal approved successful 2021 for treating cancers linked to von Hippel-Lindau illness and its statement was expanded successful 2023 to see advanced renal compartment carcinoma. MSD acquired the cause done its $2.2bn acquisition of Peloton Therapeutics successful 2019.

The FDA has besides granted accelerated support to AbbVie’s Emrelis for the attraction of antecedently treated, locally precocious oregon metastatic non-squamous non–small-cell lung crab (NSCLC) with precocious c-Met macromolecule overexpression. This is the archetypal FDA-approved therapy for this circumstantial biomarker-defined subgroup.

Emrelis’ support is based connected results from the Phase II LUMINOSITY proceedings (NCT03539536), which showed an ORR of 35% and a median DoR of 7.2 months successful 84 patients. A Phase III confirmatory trial, TeliMET NSCLC-01 (NCT04928846), is presently underway.

The cause is 1 of respective assets AbbVie is advancing to offset declining income of Imbruvica (ibrutinib), which fell by astir 12% year-over-year successful Q1 2025 to $738m. Emrelis joins Elahere (mirvetuximab soravtansine), an ADC acquired done AbbVie’s $10.1bn purchase of ImmunoGen, arsenic portion of the company’s broader strategy successful oncology.

According to GlobalData’s Pharma Intelligence Center, planetary income of Welireg and Emrelis are projected to scope $1.7bn and $624m, respectively, by 2030.