FDA approves Pfizer’s lung cancer drug Xalkori
pharmafile | August 30, 2011 | News story | Sales and Marketing | FDA, Pfizer, Xalkori, crizotinib
Pfizer’s lung cancer drug Xalkori has been approved by the FDA, a month ahead of schedule.
Xalkori (crizotinib) is now approved in the US to treat advanced non-small cell lung cancer patients over-expressing the anaplastic lymphoma kinase (ALK) gene.
Around 1-7% of patients express the ALK gene and this mutation is normally associated with non-smokers. A diagnostic test allows doctors to detect which patients express the gene and could therefore benefit from the drug.
Xalkori is priced at $9,600 a month and is predicted to reach annual peak sales of around $2.5 billion, according to analysts.
The drug has also been approved in tandem with a companion diagnostic tool, which is manufactured by Abbott.
Ian Read, president and chief executive of Pfizer, said: “The acceleration, collaboration and critical focus of the Xalkori clinical development programme reflect Pfizer’s ‘precision medicine’ approach to advancing our pipeline and strengthening our innovative core to deliver medicines that matter most.”
Pfizer is also awaiting further regulatory decisions on two other new oncology drugs – bosutinib for certain types of blood cancer and axitinib for renal cell carcinoma.
Pfizer will hope this drug will help offset the looming US patent loss of its biggest earner Lipitor, which was making around $15 billion a year in peak sales.
Targeted treatment
Pfizer’s drug was the star of the ASCO cancer congress earlier this year and was given a ‘rolling status’ by the US regulator in order to bring it to market quickly.
This speeds up the review process for a drug, and has led to Xalkori being approved a month ahead of its scheduled date of 30 September.
This is the second targeted treatment the FDA has approved in recent weeks, after it passed Roche’s Zelboraf and its diagnostic kit earlier this month.
Xalkori works by blocking certain proteins called kinases, including the protein produced by the abnormal ALK gene and is a pill taken twice a day as a single-agent treatment.
Dr Paul Bunn, the James Dudley chair in cancer research at the University of Colorado, Denver, said: “By truly understanding the underlying genetic drivers of non-small cell lung cancer, such as ALK, we can select patients who are more likely to respond to treatment – Xalkori provides a model for how to approach future drug development and cancer care.
“[This is] the first new drug approved for lung cancer by the FDA in more than six years, it represents a paradigm shift in NSCLC treatment, where we’re moving away from a one-size-fits-all approach to biomarker-based treatment decisions.”
AstraZeneca’s Iressa is an existing targetted treatment for NSCLC. Iressa (gefitinib) is for patients who carry the EGFR gene, which represents around 10-20% of all NSCLC patients.
Impressive results
The approval is based on impressive clinical trial results, one of which saw half of patients see their tumours shrink or disappear for an average of 42 weeks.
In a later study, 61% of patients had that effect for an average of 48 weeks, which is more notable given that this was for the late-stage of the disease where prognosis is very poor.
The most common side effects reported in patients receiving Xalkori included vision disorders, nausea, diarrhoea, vomiting, swelling (oedema), and constipation.
The most serious adverse event seen in trials was inflammation of the lung tissue (pneumonitis), which can be life threatening.
Pfizer will now wait for a European decision on the drug, which is expected later in the year.
Ben Adams
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