AstraZeneca receives marketing approval for Osimertinib in India
By IANS |
Published on
Wed, Mar 10 2021 20:21 IST |
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Bengaluru, March 10 : Pharmaceutical company AstraZeneca India on Wednesday announced that it has received marketing approval for Tagrisso (Osimertinib) for adjuvant treatment after complete tumour resection in patients with non-small cell lung cancer (NSCLC), whose tumours have epidermal growth factor receptor (EGFR) mutations.
Osimertinib, a once daily oral pill, when given to patients of lung cancer whose tumour has a specific mutation called EGFR mutation and who have undergone surgical removal of the lung tumour, has shown to decrease the risk of cancer recurrence by nearly 83 per cent in the ADAURA clinical trial in early stage lung cancer patients, the company said in a statement.
/PRNewswire/ Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR® artificial intelligence ("A.I.").
ISB and a collaborative team of researchers looked at hexokinase-2, or HK2, a key enzyme in glucose metabolism. A set of previous reports from our collaborator Dr. Herschman (co-author of the paper) and others revealed that cancer cells often rely on HK2 to elevate glucose metabolism to fuel their uncontrolled growth, making this enzyme a desirable target for testing, said ISB Assistant Professor Dr. Wei Wei, the lead corresponding author of the paper.
Conventional CTC detection methods, as exemplified by the FDA-cleared CellSearch system, normally rely on the use of a family of proteins called cytokeratins (CKs) that are typically found in epithelial tissues. As roughly 90 percent of human cancers arise in epithelial tissues and express CKs, these methods work very well in many major cancer types. However, their performance in NSCLC is suboptimal, despite the highly aggressive nature of NSCLC, which represents a long-standing puzzle in this field.
Crizotinib (Xalkori) has approval as first-line therapy for
ROS1 fusion-positive metastatic NSCLC but has poor CNS penetration, the authors noted, adding that in about half of patients treated with crizotinib, initial progression occurs only in the CNS.
Entrectinib is designed to cross the blood-brain barrier, and preclinical studies showed that the agent achieves high CNS concentrations, which were associated with strong efficacy in brain-tumor models.
Integrated Analysis
For the analysis, the investigators evaluated entrectinib in three phase I or II clinical trials of patients with locally advanced or metastatic
ROS1 fusion-positive NSCLC. A preliminary analysis of a 53-patient efficacy-evaluable population showed a 77% objective response rate (ORR) and a median duration of response (DoR) of 24.6 months.
A team of Roswell Park Comprehensive Cancer Center researchers has identified a new biomarker that could predict response to immune checkpoint inhibitors (ICI) shortly after patients with non-small cell lung cancer (NSCLC) initiate therapy.