AbbVie’s Emrelis (telisotuzumab vedotin-tllv) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat a subset of lung cancer patients.
The drug has been authorised to treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) in adults who exhibit high overexpression of the c-Met protein and have previously received systemic therapy.
An estimated 226,650 people will be diagnosed with lung cancer in the US this year, with NSCLC accounting for around 85% of all cases.
Approximately 25% of patients with advanced EGFR wild type, non-squamous NSCLC exhibit c-Met protein overexpression, which is linked with a poor prognosis, and around half of these patients have high c-Met overexpression.
Emrelis is specifically directed against c-Met and belongs to a relatively new class of drugs called antibody-drug conjugates (ADCs), which combine the selectivity of antibodies with the potent cell-killing power of chemotherapy or other anti-cancer agents.
“People with c-Met overexpressing NSCLC have poor prognosis and limited treatment options, and Emrelis is a first-in-class ADC that can address a critical unmet need for this patient population,” said Jonathan Goldman, professor of medicine, director of thoracic oncology clinical trials, UCLA.
The US approval was supported by results from the mid-stage LUMINOSITY trial, in which Emrelis was associated with a 35% overall response rate and median duration of response of 7.2 months in patients with high c-Met protein overexpression.
In line with the FDA’s accelerated approval programme, which expedites the approval of drugs that treat serious conditions and fill an unmet need, continued approval for Emrelis in this indication may be contingent on the verification and description of clinical benefit in a confirmatory trial.
Alongside its decision on Emrelis, the regulator has approved Roche’s VENTANA MET (SP44) RxDx Assay as a companion diagnostic test to help detect c-Met protein overexpression in patients who may be eligible for AbbVie’s drug.
Matt Sause, chief executive officer of Roche Diagnostics, said: “Understanding the molecular drivers in patients with NSCLC is critical for therapy selection.
“By identifying MET protein expression at the appropriate stage in the patient journey, we can help provide timely, tailored treatment options that may improve patient outcomes and offer hope to those facing this challenging disease.”