- PMLiVE
Johnson & Johnson’s (J&J) Lazcluze (lazertinib) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as part of a combination treatment for a subset of lung cancer patients.
The drug has been authorised for use alongside J&J’s approved cancer drug Rybrevant (amivantamab) to treat adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and has undergone specific changes in the epidermal growth factor receptor (EGFR) gene.
Approximately 47,000 people are diagnosed with lung cancer every year in the UK, and NSCLC accounts for up to 85% of all cases. Alterations in EGFR are among the most common driver mutations in patients with NSCLC, particularly in those with lung adenocarcinoma.
Taken daily in tablet form, Lazcluze is designed to block EGFR, which may help to slow or stop the lung cancer from growing, as well reduce tumour size.
The MHRA’s decision on the drug was supported by positive results from the late-stage MARIPOSA study, which compared Rybrevant plus Lazcluze against the current first-line standard of care, AstraZeneca’s Tagrisso (osimertinib), in this patient population.
The trial met its primary endpoint, with J&J’s combination demonstrating a 30% reduction in the risk of disease progression or death compared to Tagrisso at a median follow-up of 22 months.
The median duration of response was also longer for patients receiving Rybrevant plus Lazcluze compared to Tagrisso, at 25.8 versus 16.8 months, and the safety profile of the combination was consistent with previous reports from phase 1 to 2 studies.
Julian Beach, MHRA interim executive director of healthcare quality and access, said: “Patient safety is our top priority, which is why I am pleased to confirm approval of [Lazcluze] for the treatment of adults with NSCLC.
“We’re confident that the appropriate regulatory standards of safety, quality and effectiveness for the approval of this new formulation have been met. As with all products, we will keep its safety under close review.”
The approval comes just over two months after the European Commission approved the Lazcluze/Rybrevant combination for EGFR-mutated NSCLC.
Henar Hevia, senior director, EMEA therapeutic area lead, oncology, J&J Innovative Medicine, said the EU approval “[marked] significant progress for those living with the devastating impact of EGFR-mutated NSCLC, who too often face a poor prognosis and limited treatment options”.