The regulator has adopted positive opinion and recommended conditional marketing authorization for Lorviqua as monotherapy treatment for adult patients with ALK-positive advanced NSCLC whose disease has progressed after alectinib or ceritinib as the first ALK TKI therapy or crizotinib and at least one other ALK TKI.
The European Commission (EC) will assess the CHMP’s opinion to grant marketing approval for Lorviqua. The decision is expected to be announced in the coming months.
Lorviqua’s marketing authorization application (MAA) was based on B746100 non-randomized, dose-ranging and activity-estimating, multi-cohort and multi-center phase 1/2 study.
The trial has been designed to assess Lorviqua to treat patients with ALK-positive advanced NSCLC, who were previously treated with one or more ALK TKIs.
Pfizer recruited 229 patients with ALK-positive metastatic NSCLC across various subgroups based on prior treatment.
Lorviqua is a TKI that demonstrated to be highly active in preclinical lung cancer models sheltering chromosomal rearrangements of ALK.
Lorviqua has been specifically designed to restrict tumor mutations that drive resistance to other ALK inhibitors and penetrate the blood brain barrier.
It has been approved in the US, Canada and Japan under the brand name Lorbrena to treat patients with ALK-positive metastatic NSCLC.
According to Pfizer, lung cancer is the most common cancer with over two million new cases diagnosed globally in 2018.
Pfizer global product development chief development officer Dr Chris Boshoff said: “Addressing drug resistance and relapse remains a challenge in the treatment of ALK-positive non-small cell lung cancer.
“This CHMP opinion represents a step forward in bringing LORVIQUA to patients in Europe living with advanced ALK-positive non-small cell lung cancer who have limited treatment options.”
Pfizer’s oncology division is engaged in the development of efficacious and tolerable therapies for NSCLC, including biomarker-driven therapies and immuno-oncology (IO) agents and combinations.
The firm’s oncology division has a portfolio of 18 approved cancer medicines and biosimilars across over 20 indications, including breast, prostate, kidney, lung and hematology.