The US Food and Drug Administration (FDA) has approved two oncology drugs: MSD’s Welireg (belzutifan) and AbbVie’s Emrelis (telisotuzumab vedotin-tllv). The decisions, announced on 14 May, expand both individual companies’ oncology portfolios and target distinct patient populations.
MSD received FDA approval to market Welireg for the treatment of adults and children aged 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL).
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Welireg is now the first oral treatment option available for treatingPPGL. The rare condition affects an estimated 2,000 patients annually in the US and is associated with adrenal gland tumours that produce excess adrenaline. This approval could represent a “change to the treatment paradigm for eligible patients”, according to Camilo Jimenez, professor for the Department of endocrine neoplasia and hormonal disorders at the University of Texas MD Anderson Cancer Center.
The approval was based on the Phase II LITESPARK-015 study (NCT04924075), which included 72 patients. The study met its primary endpoint, showing an objective response rate (ORR) of 26%. Data on secondary endpoints included a median duration of response (DoR) of 20.4 months. Among patients on antihypertensive medication at baseline, 32% saw a sustained reduction in at least one drug.
Welireg was first approved in 2021 for treating cancers linked to von Hippel-Lindau disease and its label was expanded in 2023 to include advanced renal cell carcinoma. MSD acquired the drug through its $2.2bn acquisition of Peloton Therapeutics in 2019.
The FDA has also granted accelerated approval to AbbVie’s Emrelis for the treatment of previously treated, locally advanced or metastatic non-squamous non–small-cell lung cancer (NSCLC) with high c-Met protein overexpression. This is the first FDA-approved therapy for this specific biomarker-defined subgroup.
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By GlobalDataEmrelis’ approval is based on results from the Phase II LUMINOSITY trial (NCT03539536), which showed an ORR of 35% and a median DoR of 7.2 months in 84 patients. A Phase III confirmatory trial, TeliMET NSCLC-01 (NCT04928846), is currently underway.
The drug is one of several assets AbbVie is advancing to offset declining sales of Imbruvica (ibrutinib), which fell by nearly 12% year-over-year in Q1 2025 to $738m. Emrelis joins Elahere (mirvetuximab soravtansine), an ADC acquired through AbbVie’s $10.1bn purchase of ImmunoGen, as part of the company’s broader strategy in oncology.
According to GlobalData’s Pharma Intelligence Center, global sales of Welireg and Emrelis are projected to reach $1.7bn and $624m, respectively, by 2030.
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On the same day as Emrelis’ approval, AbbVie announced a collaboration with ADARx Pharmaceuticals, committing $335m upfront to access ADARx’s siRNA platform. The deal aims to leverage both companies’ expertise in RNA technologies, ADCs, and targeted delivery.
