After flexing its antibody-drug conjugate bona fides at last year’s American Society of Clinical Oncology (ASCO) conference, AbbVie is advancing its solid tumor ambitions with a new FDA green light.

The FDA on Wednesday granted an accelerated approval to AbbVie’s c-Met-directed ADC Emrelis, also known as telisotuzumab vedotin-tllv, as a new treatment option for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) who’ve previously received systemic therapy. The drug is cleared in patients whose tumors exhibit high overexpression of the c-Met protein.

The c-Met protein is overexpressed in around 25% of patients with advanced epidermal growth factor receptor wild-type, non-squamous NSCLC, and roughly half of those patients have high c-Met overexpression, AbbVie explained in a press release.

As a member of the ADC class of drugs, which joins targeted antibodies with potent chemical payloads, Emrelis can home in on c-Met-expressing cancer cells for a precision strike.

Given the nature of the FDA’s accelerated approval pathway, AbbVie may have to leverage data from a confirmatory trial to keep hold of its approval in the long run. The FDA signed off on the therapy after reviewing data from the phase 2 Luminosity study, in which Emrelis charted a 35% overall response rate (ORR) and a median duration of response (DOR) of 7.2 months in c-Met-high patients.

AbbVie is leveraging the ongoing Luminosity trial to pinpoint c-Met overexpressing NSCLC patient populations best suited for telisotuzumab as a second- or third-line monotherapy. Once those groups are selected, AbbVie aims to further gauge efficacy across metrics like ORR and DOR, as well as disease control rate, progression-free survival and overall survival.

AbbVie is already running a phase 3 confirmatory study on Emrelis in c-Met-overexpressing NSCLC dubbed TeliMET NSCLC-01, which pits the ADC against the chemotherapy docetaxel.

Emrelis represents AbbVie’s first internally developed solid tumor drug and its first solid tumor drug to win FDA approval in lung cancer, Roopal Thakkar, M.D., the company’s chief scientific officer, said in a statement.

The regulatory win comes after AbbVie executives stressed their commitment to the ADC field in an interview with Fierce Biotech at last year’s ASCO conference in Chicago.

“You look back five years ago, ADCs were primarily in the hematology space,” Daejin Abidoye, M.D., VP and therapeutic area head for solid tumors at AbbVie, said at the time. “Now you're seeing ADCs playing a significant role in solid tumors.”

“We want to be part of that wave,” Pedro Valencia, Ph.D., VP, asset strategy leadership, oncology at AbbVie, added during the joint interview.

Although Emrelis marks AbbVie’s first internal ADC win, the company already has a separate commercial treatment in the ovarian cancer ADC Elahere, which it picked up through its $10.1 billion acquisition of ImmunoGen in early 2024.

At the time the deal was announced, former AbbVie CEO Richard Gonzalez noted that establishing a foothold in solid tumors was a major priority for the company.

AbbVie also has several other internal candidates working their way through the clinic, such as the SEZ6-directed ADC ABBV-706 in small cell lung cancer and another c-Met-directed ADC coded ABBV-400, which is being evaluated in colorectal cancer.

As for Emrelis itself, the drug is likely to receive a positive reception among doctors if the results of a ZoomRx survey from last summer ring true.

In the poll, which ZoomRx conducted last June, 55% of oncologists said they were aware of AbbVie’s drug, and nearly one-quarter of those surveyed named telisotuzumab as one of the three most exciting cancer prospects in development at the time. Those results were strong enough to make Emrelis the most widely anticipated program in the survey.

Further, nearly one-third of the oncologists said they viewed telisotuzumab as a game changer, with roughly 25% saying they would prescribe the AbbVie ADC.