The EC approval was based on results from the Phase 3 CROWN trial, in which Lorviqua reduced the risk of disease progression or death
Flags in front of the European Commission building in Brussels, Switzerland. (Credit: Sébastien Bertrand/Wikipedia.)
Pfizer has received the European Commission (EC) marketing authorisation for Lorviqua (lorlatinib) as a monotherapy to treat a type of non-small cell lung cancer (NSCLC).
The drug was indicated to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC, previously not treated with an ALK inhibitor.
Lorviqua is a tyrosine kinase inhibitor (TKI) that showed superior activity in preclinical lung cancer models harbouring chromosomal rearrangements of ALK.
It was specifically developed to inhibit tumour mutations that drive resistance to other ALK inhibitors and to penetrate the blood brain barrier, said Pfizer.
The EC approval follows a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), issued in December last year.
The drug has been approved in the US under the brand name Lorbrena, to treat ALK-positive metastatic NSCLC in adults, as detected by an FDA-approved test.
In 2019, the EC authorised Lorviqua for the treatment of ALK-positive advanced NSCLC in adults whose disease has progressed after initial TKI therapy.
Pfizer Oncology global president and general manager Andy Schmeltz said: “For more than a decade, Pfizer has worked tirelessly in its pursuit to help transform the trajectory for people living with advanced, biomarker-driven lung cancers.
“The European Commission’s approval of LORVIQUA as a first-line therapy is a significant milestone that we hope will help bring a needed and meaningful difference to those impacted by this deadly disease in Europe.”
The EC approval was based on the results from the Phase 3 CROWN trial, in 296 people with previously untreated advanced ALK-positive NSCLC.
The primary endpoint of the trial was progression-free survival (PFS) based on the blinded independent central review (BICR).
Overall survival (OS) and tumour assessment-related data by BICR, ORR, and duration of response (DOR), including the secondary endpoints.
In the study, treatment using Lorviqua as monotherapy reduced the risk of disease progression or death by 72% compared to Xalkori (crizotinib).
A confirmed objective response rate (ORR) of 76% was achieved with Lorviqua, compared to 58% with Xalkori, which is one of the secondary endpoints.
The majority of patients with measurable brain metastases (82%) in the Lorviqua arm experienced an intracranial response, compared to 23% in Xalkori patients.
The overall safety profile of Lorviqua in the study was similar to that observed in previous studies, said Pfizer.
Recently, Pfizer announced that the European Medicines Agency (EMA) has recommended the approval of its oral antiviral Paxlovid (nirmatrelvir plus ritonavir) to treat Covid-19 in adults.