Xalkori image

Pfizer’s Xalkori impresses in new setting

pharmafile | March 26, 2014 | News story | Research and Development, Sales and Marketing NHS, NICE, NSCLC, Pfizer, Xalkori, lung cancer 

Pfizer’s lung cancer treatment Xalkori has proven better at treating patients in a first-line setting when compared to chemotherapy.

This is according to new data from the PROFILE 1014 Phase III trial which showed that Xalkori (crizotinib) achieved its primary endpoint of significantly prolonging progression-free survival (PFS).

This was met in previously untreated patients with a mutation of the ALK gene and who had advanced non-squamous non-small cell lung cancer (NSCLC) – Pfizer’s drug was found to outperform standard platinum-based chemotherapy regimens in this setting.

The drug was first approved in 2011 through the FDA’s accelerated approval programme for a small patient population who are in the late-stage of the disease, and have the anaplastic lymphoma kinase (ALK) gene mutation, as determined by an approved diagnostic test.

Around 1-7% of patients express the ALK gene and this mutation is normally associated with non-smokers.

But these latest data could see Pfizer seek a new indication for its drug that would allow Xalkori to be used as a first-line therapy, meaning it could treat more patients and thus produce more revenue for the company.

Xalkori saw sales of around $350 million last year but is expected to get a significant boost from the new data. Analysts at Cowen and Co have predicted the medicine could generate annual peak sales of around $1 billion by 2020, putting it into the blockbuster bracket.

Pricing woes

The drug showed promise at the ASCO cancer conference in 2011, and since its approval in the same year its revenue generation has been equally impressive.

The one sticking point for Pfizer has been pricing watchdogs – last year England’s NICE rejected the medicine for NHS funding saying it was not value for money, despite the firm offering a price cut.

Before the discount a month’s worth of Xalkori costs £4,689, and NICE estimates the average cost of a course of treatment would be between £37,512 and £46,890 – rising to more than £51,000 if patients are treated after progression.

Last year the German equivalent of NICE – health technology assessor IQWiG – also questioned the drug’s cost-effectiveness, saying there were ‘hints’ of better quality of life, “but also of more frequent, sometimes serious, side effects”. It concluded that “overall, the added benefit is regarded as not proven”.

Revenue driver

But despite some market access issues, Pfizer is pushing forward with oncology, and has a number of cancer medicines in development that it hopes will shore up future growth for the firm.

Other recent cancer medicines that have gained approval for Pfizer include Bosulif (bosutinib) as a treatment for previously-treated chronic myeloid leukaemia (which was also rejected by NICE), and Inlyta (axitinib) for renal cell carcinoma (which did eventually gain a NICE recommendation).

But any one of these new drugs will struggle to replicate the sales of its statin Lipitor (atorvastatin), which made more than $14 billion in peak annual sales before losing its patent in 2011.

Ben Adams 

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