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# AbbVie Scraps Accelerated Approval for Lung Cancer Therapy
- URL: https://www.fdaweb.com/abbvie-scraps-accelerated-approval-for-lung-cancer-therapy/
- Published: 2018-03-22T12:00:00.000Z
- Updated: 2026-09-14T23:54:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141039

After consulting with FDA, AbbVie has decided to not seek accelerated approval for Rova-T (rovalpituzumab tesirine) as a third-line treatment for relapsed/refractory small cell lung cancer based on the magnitude of effects across multiple parameters in a single-arm study. “Although the results from the study were not what we hoped for, we look forward to receiving data from the ongoing Phase 3 studies in the first- and second-line settings and remain committed to developing Rova-T for the treatment of patients with small cell lung cancer,” the company said.

The TRINITY study’s primary objective was to investigate the efficacy of Rova-T as third-line and later treatment for certain lung cancer patients. Secondary objectives included assessment of safety and tolerability, pharmacokinetics, progression-free survival, duration of response and clinical benefit rate, AbbVie said.

Rova-T is an investigational antibody-drug conjugate targeting the cancer-stem cell-associated delta-like protein 3 (DLL3), which is expressed in more than 80% of small cell lung cancer patient tumors. It combines a targeted antibody that delivers a cytotoxic agent directly to the DLL3-expressing cancer cells while minimizing toxicity to healthy cells, the company says.