US patients with late-stage, non-small cell lung cancers (NSCLC) could receive Pfizer’s recently approved Xalkori (crizotinib) for free, instead of paying $115,000 per year.
The expensive drug has proved to extend patients’ lives with the rare form of cancer, but Pfizer is making efforts to ensure patients don’t have to pay the entire cost. The company has stated it will cover insurance copayments that are more than $100, and in some cases give the drug away for free to patients who are either uninsured or underinsured.
Geno Germano, who runs Pfizer’s specialty-care and cancer businesses, told Wall Street Journal: “The results may not achieve multi-billion-dollar sales, but whether that yields a product for tens of millions of patients or 10,000 patients, we're interested”.
In clinical trials, the average duration of treatment was between 22 and 32 weeks, but because the drug appears to extend patients’ lives, many may be on it for far longer than that, totaling a potentially hefty bill. One study reported that 60% of patients on Xalkori stayed alive after two years of the treatment.
The drug has been approved with a companion diagnostic test that will determine if a patient has the abnormal anaplastic lymphoma kinase (ALK) gene. These genes are responsible for cancer growth and development and are specifically targeted by the drug.
Dr Richard Pazdur, Director of the Office of Oncology Drug Products for the FDA, said: “The approval of Xalkori with a specific test allows the selection of patients who are more likely to respond to the drug”.
Between 1% and 7% of those with NSCLC have the ALK gene abnormality, those of which are typically non-smokers.
Ian Read, CEO of Pfizer, stated: “Xalkori is an advance in the treatment of this devastating illness, providing a new therapeutic option for a subset of patients with the disease.”
The safety and effectiveness of the medication were tested in two multi-centre, single-arm trials involving 255 patients with late-stage ALK-positive NSCLC.
In one study, the objective response rate was 50% with an average response duration of 42 weeks. In another, the same statistic was 61% with an average response of 48 weeks.
Xalkori is the second drug approved by the FDA this year to benefit cancer patients with specific mutations. The first was Zelboraf, developed and manufactured by Daiichi Sankyo and Roche.
Alberto Gutierrez, Director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA, commented: “The trend in oncology research continues towards targeted therapies”.
Pfizer has also applied for approval of Xalkori with the European Medicines Agency.