Lorbrena Clinical Trials: Efficacy, Safety, and Outcomes

Introduction

Lorbrena (Lorlatinib) is a prescribed medication designed for the treatment of adults diagnosed with non-small cell lung cancer (NSCLC) that has metastasized to other regions of the body and is characterized by a specific genetic mutation known as ALK. Through clinical trials, the drug has exhibited promising effectiveness and safety outcomes, establishing itself as a valuable therapeutic choice for individuals dealing with ALK-positive metastatic NSCLC.

Efficacy

The efficacy of Lorbrena was evaluated in a single, non-randomized, multi-center, dose-ranging clinical trial conducted at 47 sites in Asia, Australia, Canada, Europe, and the United States. The trial was designed to assess the benefits of Lorbrena in patients with metastatic NSCLC and ALK mutations who had previously been treated with anti-cancer drugs. The primary endpoint of the trial was compared to XALKORI (crizotinib), and Lorbrena demonstrated a 73% reduction in the rate of progression or death.

Safety

Lorbrena can harm the fetus, so pregnant women should avoid it. Avoid breastfeeding during and seven days post Lorbrena treatment. Females of reproductive potential should use effective non-hormonal contraception during and six months after treatment. Use non-hormonal methods due to hormonal contraceptive interference. Males with female partners should use effective contraception during and three months after treatment. Lorbrena’s safety and efficacy in pediatric patients are not established. No dosage adjustment is needed for mild hepatic impairment, but reduce the dose for severe renal impairment.

The most frequent adverse reactions associated with Lorbrena were edema, peripheral neuropathy, weight gain, cognitive effects, fatigue, dyspnea, and arthralgia. Serious side effects are pneumonia, dyspnea, respiratory failure, cognitive effects, and pyrexia. 

Subsequent Studies

Follow-up analysis of the CROWN trial demonstrated a sustained benefit for Lorbrena, with a 72% reduction in the risk of progression or death. The safety profile observed in the three-year follow-up analysis was consistent with the established safety profile. An informal follow-up analysis at a median of 36 months showed that the side effects experienced by patients in the follow-up analysis were similar to those in the main analysis, with no new safety concerns arising.

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Reference: 

1.  https://www.pfizer.com/news/press-release/press-release-detail/three-year-follow-data-phase-3-crown-trial-pfizers 
2.  https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-lorbrena 
3.  https://classic.clinicaltrials.gov/ct2/show/NCT03844464 
4.  https://www.lorbrena.com/clinical-study-results 
5. https://www.pfizer.com/news/press-release/press-release-detail/results-phase-3-crown-trial-pfizers-lorbrenar-lorlatinib 
6.  https://lorbrena.pfizerpro.com/first-line-efficacy