Lorlatinib is under clinical development by Pfizer and currently in Phase I for Neuroblastoma. According to GlobalData, Phase I drugs for Neuroblastoma have an 85% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Lorlatinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Lorlatinib overview

Lorlatinib (Lorviqua / Lorbrena/ Lorlak) is a kinase inhibitor act as anti-neoplastic agent. It is formulated as tablets, coated tablets, film coated tablets for oral route of administration. It is indicated for the treatment of unresectable advanced or recurrent ALK fusion gene positive non-small cell lung cancer unresectable advanced or recurrent fusion gene positive, resistance or intolerance to ALK tyrosine kinase inhibitors, and also for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease, or alectinib as the first ALK inhibitor therapy for metastatic disease, or ceritinib as the first ALK inhibitor therapy for metastatic disease. Lorbrena is indicated as monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).

Lorlatinib (PF-06463922) is under development for the treatment of metastatic non-small cell lung cancer, anaplastic large cell lymphoma, neuroblastoma, high-grade (HGG), including diffuse intrinsic pontine gliomas (DIPG) anaplastic astrocytoma, glioblastoma. The drug candidate is a new molecular entity (NME). The drug candidate is administered orally as a tablet. It is an ATP competitive small molecule inhibitor of anaplastic lymphoma kinase (ALK) and ROS1. It was under development for the treatment of lymphoma and glioblastoma multiforme.

Pfizer overview

Pfizer discovers, develops, manufactures, and commercializes biopharmaceuticals. The company offers products to treat various conditions such as cardiovascular, metabolic and pain, women’s health, cancer, inflammation, immune disorders, and rare diseases. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services. Pfizer sells its products through wholesalers, retailers, hospitals, individual provider offices, clinics, government agencies, and pharmacies. It has major manufacturing facilities in India, China, Japan, Ireland, Italy, Belgium, Germany, Singapore, and the US. The company provides its products in North America, South America, Asia-Pacific, Australia, Europe, Africa, and the Middle East. Pfizer is headquartered in New York, the US.

For a complete picture of Lorlatinib’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 22 April 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.