AbbVie wins UK NICE endorsement for subcutaneous Tepkinly in DLBCL

2024-02-02

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AbbVie wins UK NICE endorsement for subcutaneous Tepkinly in DLBCL

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来源: Pharmaceutical Technology

Tepkinly has received accelerated approval from the FDA and a conditional marketing authorisation from the European Commission as third-line therapy in adult patients with DLBCL. Image Credit: JHVEPhoto / Shutterstock.

The UK’s National Institute for Health and Care Excellence (NICE) has recommended AbbVie’s Tepkinly (epcoritamab) as a third-line treatment option for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

NICE has endorsed Tepkinly in DLBCL patients whose cancer has returned or has not responded to at least two previous treatments. The therapy is only recommended for patients who have already either received Roche’s Polivy (polatuzumab vedotin) or it is either contraindicated or not tolerated.

Tepkinly is a bispecific CD20 CD3 T-cell engager. The therapy was developed by Genmab using DuoBody technology and was licensed by AbbVie, along with two other bispecific antibodies, DuoHexaBody-CD37 and DuoBody-CD3x5T4.

In May 2023, Tepkinly received accelerated approval from the US Food and Drug Administration (FDA) as a third-line therapy in adult patients with DLBCL. The drug is marketed as Epkinly in the US. The therapy was also granted conditional marketing authorisation from the European Commission (EC) for the same indication as approved by the FDA.

The NICE recommendation, along with the FDA and EC approval, were based on data from the Phase I/II EPCORE NHL-1 trial (NCT03625037). The 139 patients enrolled in the study showed an overall response rate of 62% and a complete response rate of 39%. The therapy also prevented the growth or spread of the DLBCL for an average of 15.6 months.

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Tepkinly generated $14m in US sales in Q3 2023, as per AbbVie’s financials. GlobalData forecasts that its first-to-market advantage could propel Epkinly sales to exceed $1.8bn in 2029.

GlobalData is the parent company of Pharmaceutical Technology.

AbbVie has recently invested in expanding its oncology pipeline with an acquisition of ImmunoGen for approximately $10.1bn in November 2023. The deal is expected to close in mid-2024 and will give AbbVie access to the company’s lead antibody-drug candidate, Elahere (mirvetuximab soravtansine-gynx). In November 2022, the therapy received accelerated approval to treat folate receptor alpha (FRα)-positive, platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer.

Additionally, AbbVie signed a collaboration agreement with BigHat Biosciences to identify and develop antibody therapies in oncology and neuroscience indications, in December 2023. The company paid a $30m upfront payment, with an option to pay up to approximately $325m in research and development and commercial milestone-based payments along with tiered royalties on net sales.

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