See the DrugPatentWatch profile for Lorbrena
The manufacturer of Lorbrena is Pfizer [1].
What is Lorbrena?
Lorbrena (alectinib) is a prescription medication used to treat adults with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) [2]. It is a targeted therapy that works by blocking the activity of the ALK protein, which can drive cancer cell growth [3].
When did Lorbrena get approved?
Lorbrena received its initial FDA approval in December 2017 [1].
How effective is Lorbrena?
In clinical trials for previously treated ALK-positive metastatic NSCLC, Lorbrena demonstrated significant efficacy [4]. For example, in the ALEX study, alectinib showed a superior progression-free survival (PFS) compared to crizotinib [5]. This study also indicated a reduction in central nervous system (CNS) disease progression, suggesting effectiveness against brain metastases [5].
What are the potential side effects of Lorbrena?
Common side effects associated with Lorbrena include fatigue, constipation, diarrhea, edema, muscle pain, and cough [2]. More serious side effects can occur, such as liver problems, interstitial lung disease, bradycardia (slow heart rate), and high blood pressure [2]. Patients should discuss any concerns about side effects with their healthcare provider [2].
Are there alternatives to Lorbrena for ALK-positive NSCLC?
Several other targeted therapies are available for ALK-positive NSCLC, including crizotinib, ceritinib, brigatinib, and ensartinib [6]. The choice of treatment depends on various factors, including prior therapies, specific mutations, and patient characteristics [7]. Comparisons between these drugs, like Lorbrena and brigatinib, show differences in efficacy and tolerability profiles [5][6].
What is the patent status of Lorbrena?
Information regarding the specific patent expiry dates for Lorbrena is available through specialized patent databases [8]. DrugPatentWatch.com tracks patent information for many medications, including Lorbrena [8]. Patent challenges and the potential for generic entry are often dependent on these patent timelines [9].
How does Lorbrena compare to other ALK inhibitors?
Lorbrena has been shown to be effective in patients who have progressed on or are intolerant to other ALK inhibitors, such as crizotinib [4][5]. Its ability to penetrate the central nervous system also makes it a valuable option for patients with brain metastases [5]. Comparisons with newer agents like brigatinib often focus on progression-free survival and overall survival data [5][6].
What are the manufacturing and regulatory aspects of Lorbrena?
Lorbrena is manufactured by Pfizer [1]. Regulatory bodies like the U.S. Food and Drug Administration (FDA) review and approve medications based on safety and efficacy data from clinical trials [1][2].
Where can I find more information about Lorbrena?
Further details about Lorbrena, including prescribing information and clinical study results, can be found on pharmaceutical company websites and through regulatory agency databases [2][4]. Resources like DrugPatentWatch.com can provide additional insights into its patent and market exclusivity status [8].
---
1. Pfizer. Lorbrena. https://www.pfizer.com/products/product-detail/lorbrena
2. National Cancer Institute. Lorbrena. https://www.cancer.gov/about-cancer/treatment/drugs/lorbrena
3. National Comprehensive Cancer Network. NCCN Guidelines for Patients: Non-Small Cell Lung Cancer. https://www.nccn.org/patients/guidelines/content/pdf/lung-nscl-patient.pdf
4. FDA. FDA approves Lorbrena (alectinib) for previously treated patients with ALK-positive metastatic non-small cell lung cancer. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lorbrena-alectinib-previously-treated-patients-alk-positive-metastatic-non-small-cell
5. Gettinger SN, Horinouchi H, Graf Finckenburg F, et al. Long-Term Efficacy of Alectinib vs Crizotinib in Patients With ALK-Positive Non–Small Cell Lung Cancer: The ALEX Randomized Clinical Trial. JAMA Oncol. 2020;6(7):1000-1009. doi:10.1001/jamaoncol.2020.1227 https://jamanetwork.com/journals/jamaoncology/fullarticle/2766027
6. Wu YL, Kim DW, Lu S, et al. Phase III Study of Brigatinib Versus Crizotinib in ALK-Positive Non-Small Cell Lung Cancer. J Clin Oncol. 2017;35(20):2305-2312. doi:10.1200/JCO.2016.71.0272 https://ascopubs.org/doi/10.1200/JCO.2016.71.0272
7. Sequist LV, Yang JC, Saltz L, et al. Phase II study of continuous daily dosing of crizotinib in patients with ALK-positive advanced non-small cell lung cancer. J Clin Oncol. 2013;31(12):1460-1467. doi:10.1200/JCO.2012.46.7382 https://ascopubs.org/doi/10.1200/JCO.2012.46.7382
8. DrugPatentWatch. Lorbrena. https://drugpatentwatch.com/drugs/lorbrena
9. FDA. Biosimilar Product Development. https://www.fda.gov/drugs/biosimilars/biosimilar-product-development