July 2022: Crizotinib (Xalkori, Pfizer Inc.) was granted approval by the Food and Drug Administration (FDA) for the treatment of adult and paediatric patients 1 year of age and older who were diagnosed with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumours that were positive for ALK (IMT).
Both the safety and efficacy of crizotinib were evaluated in two separate multicenter, single-arm, open-label trials. These trials included both paediatric and adult patients with unresectable, recurrent, or refractory ALK-positive IMT. The paediatric patients participated in trial ADVL0912 (NCT00939770), while the adult patients participated in trial A8081013 (NCT01121588).
The objective response rate was the primary indicator of efficacy that was measured in these trials (ORR). An objective response was found in 12 out of the 14 paediatric patients (which corresponds to an 86% success rate with a 95% confidence interval ranging from 57% to 98%) when the patients were evaluated by an independent review committee. Five out of the seven adult patients exhibited objective signs of improvement.
The symptoms of vomiting, nausea, diarrhoea, abdominal pain, rash, vision disorder, upper respiratory tract infection, cough, pyrexia, musculoskeletal pain, fatigue, edoema, and constipation were the most common adverse reactions (35 percent) in paediatric patients. In adult patients, vision disorders, nausea, and edoema were the adverse reactions that occurred more frequently than thirty-five percent of the time.
Crizotinib should be administered orally twice daily at a dose of 250 milligrammes (mg) in adult patients until the disease worsens or unacceptable toxicity is reached. Orally administering 280 mg/m2 twice daily is the paediatric dose that is recommended until disease progression or unacceptable toxicity occurs.
View full prescribing information for Xalkori.
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. His career is marked by significant contributions to stem cell biology, developmental biology, and innovative research techniques.
Research Highlights
Dr. Mittal's research has focused on several key areas:
1) Cardiovascular Development and Regeneration: He studied coronary vessel development and regeneration using zebrafish models1.
2) Cancer Biology: At Dartmouth College, he developed zebrafish models for studying tumor heterogeneity and clonal evolution in pancreatic cancer.
3) Developmental Biology: His doctoral work at Keio University involved identifying and characterizing medaka fish mutants with cardiovascular defects.
4) Stem Cell Research: He investigated the effects of folic acid on mouse embryonic stem cells and worked on cryopreservation techniques for hematopoietic stem cells.
Publications and Presentations
Dr. Mittal has authored several peer-reviewed publications in reputable journals such as Scientific Reports, Cardiovascular Research, and Disease Models & Mechanisms1. He has also presented his research at numerous international conferences, including the Stanford-Weill Cornell Cardiovascular Research Symposium and the Weinstein Cardiovascular Development Conference.
In summary, Dr. Nishant Mittal is a dedicated and accomplished researcher with a strong track record in cardiovascular and cancer biology, demonstrating expertise in various model systems and a commitment to advancing scientific knowledge through innovative research approaches.
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