See the DrugPatentWatch profile for Lorbrena
Lorbrena, known chemically as lorlatinib, is a targeted therapy used to treat certain types of non-small cell lung cancer (NSCLC) that have specific genetic mutations [1]. As of now, there is no generic version of Lorbrena available on the market [2].
When does the Lorbrena patent expire?
The patents protecting Lorbrena and its use are held by Pfizer Inc. Patent expiry dates can be complex, involving multiple patents covering the compound itself, its methods of use, and formulations. DrugPatentWatch.com tracks these patent statuses and typically indicates that patents for lorlatinib are in force for several more years, suggesting that generic entry is not imminent [3]. For precise expiry dates, consulting detailed patent databases like those on DrugPatentWatch.com is necessary [3].
Can biosimilars of Lorbrena be developed?
Lorbrena is a small molecule drug, not a biologic. The term "biosimilar" applies to products that are highly similar to a reference biologic drug, and there is no direct equivalent for small molecule drugs. Instead, generic versions of small molecule drugs like Lorbrena are developed. The exclusivity period for Lorbrena, protected by patents, dictates when generic manufacturers can legally produce and market their versions.
Who makes Lorbrena?
Lorbrena is manufactured and marketed by Pfizer Inc. [1].
What is Lorbrena used to treat?
Lorbrena is prescribed for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have specific genetic mutations: anaplastic lymphoma kinase (ALK)-positive or ROS proto-oncogene 1 (ROS1)-positive NSCLC. It is used as a first-line treatment or for patients whose disease has progressed on other ALK inhibitors [1].
How does Lorbrena work?
Lorbrena is a tyrosine kinase inhibitor (TKI). It works by blocking the activity of ALK and ROS1 proteins, which are involved in the growth and spread of cancer cells in certain types of NSCLC. By inhibiting these targets, Lorbrena helps to slow or stop tumor growth [1].
What are the side effects of Lorbrena?
Common side effects associated with Lorbrena treatment can include high cholesterol (hyperlipidemia), swelling (edema), peripheral neuropathy, cognitive effects, fatigue, weight loss, and diarrhea [1]. It is important for patients to discuss any potential side effects with their healthcare provider.
What is the cost of Lorbrena?
The cost of Lorbrena can be substantial, as is typical for targeted cancer therapies. Prices can vary based on insurance coverage, pharmacy, and location. Information on specific pricing often requires direct inquiry with pharmacies or through patient assistance programs offered by the manufacturer.
What other treatments are available for ALK-positive NSCLC?
Other ALK inhibitors are available for ALK-positive NSCLC, including crizotinib, alectinib, and brigatinib [4]. The choice of treatment depends on factors such as the specific mutation, previous treatments received, and the patient's overall health. Lorbrena is often considered for patients who have progressed on earlier ALK inhibitors or as a first-line option [1][4].
What clinical trials have been conducted for Lorbrena?
Clinical trials, such as the ALEX study and the CROWN study, have evaluated the efficacy and safety of Lorbrena in patients with ALK-positive NSCLC. The CROWN study, for instance, demonstrated significant improvements in progression-free survival when Lorbrena was used as a first-line treatment compared to standard chemotherapy [1].
What is the difference between Lorbrena and other ALK inhibitors?
Lorbrena is a third-generation ALK inhibitor designed to overcome resistance mechanisms that can develop with earlier ALK inhibitors. It has activity against a broader range of ALK mutations, including the common G1202R mutation, and can penetrate the central nervous system more effectively, making it useful for treating brain metastases [1][4].
What regulatory approvals does Lorbrena have?
Lorbrena has received approval from regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of ALK-positive metastatic NSCLC [1].
---
Sources:
1. DrugPatentWatch.com
2. DrugPatentWatch.com
3. DrugPatentWatch.com
4. DrugPatentWatch.com