GSK advances oncology efforts with $10.6bn Nuvalent acquisition

GSK is acquiring US biopharma company Nuvalent for $10.6 billion, through which it will gain access to three potential best-in-class assets in lung cancer.

The agreement could lead to significant new treatment options, subject to regulatory approval.

It is the second major oncology deal announced by a pharmaceutical company in several weeks. Pfizer has agreed to acquire Innovent Biologics for up to $10.5 billion, to advance antibody-drug conjugate (ADC) therapies.

Likewise, this current deal with GSK involves three products in lung cancer in a single transaction and opens opportunity expansion with Ris-Rez, GSK’s B7-H3 ADC.

[The two lead candidates are] potential best-in-class assets that could launch this year if approved by the FDA and offer significant new treatment options to patients with two forms of non-small cell lung cancer”

Luke Miels, Chief Executive Officer, GSK

Luke Miels, Chief Executive Officer, GSK, explained that GSK’s present acquisition is a multi-product deal involving two lead products that are “potential best-in-class assets that could launch this year if approved by the FDA and offer significant new treatment options to patients with two forms of non-small cell lung cancer [(NSCLC)].”

Two of the assets are late-stage candidates zidesamtinib (NVL-520) and neladalkib (NVL-655). Data presented at the IASLC 2025 World Conference on Lung Cancer and the 2026 ASCO Annual Meeting have illustrated the best-in-class potential of these next-generation, highly selective ROS1 and ALK inhibitors in NSCLC. These candidates are intended to address the efficacy and/or tolerability limitations of existing therapies.

The third asset is NVL-330, a potential best-in-class HER2 inhibitor for NSCLC.

Amgen recently gained regulatory approval in lung cancer from the European Commission, making Imdelltra as the first T-cell engagement therapy for small cell lung cancer (SCLC).

James Porter, PhD, Chief Executive Officer, Nuvalent, said: “Since our founding, we have leveraged our deep expertise in chemistry and structure-based drug design to develop a portfolio of novel, potentially best-in-class kinase inhibitors.

“GSK’s proven track record, infrastructure, and expertise will support the successful commercialisation of zidesamtinib and neladalkib, as well as accelerate advancement of our broader discovery pipeline.”

The firm’s acquistion of Nuvalent is subject to customary closing conditions.