Double approval for Pfizer cancer drugs
pharmafile | September 6, 2012 | News story | Sales and Marketing | CML, Cancer, Glivec, Pfizer, axitinib, rcc
Two cancer drugs from Pfizer have been approved, one in Europe for kidney cancer and another in the US for a form of leukaemia.
The European Commission has given the nod to Inlyta (axitinib) for adults with advanced renal cell carcinoma (RCC), after treatment with Pfizer’s own Sutent (sunitinib) or a cytokine has failed.
At the same time the FDA has switched on the green light for Bosulif (bosutinib) for previously-treated adults with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukaemia.
Inlyta’s approval is based on the phase III AXIS trial in which it offered median progression-free survival of 6.8 months compared to 4.7 months from Bayer’s RCC drug Nexavar (sorafenib), a current second-line standard of care.
Inlyta, which comes in pill form, is a multi kinase inhibitor that targets VEGF receptors 1, 2 and 3 and gained FDA approval in January.
RCC is the sixth leading cause of cancer-related death, with 102,000 people per year diagnosed in Europe.
Meanwhile once-daily Bosulif is one of few treatment options for chronic myelogenous leukaemia, one of the four most common types of the disease, with than 5,000 new cases each year in the US.
Pfizer says it is the only therapy approved with pivotal trial data including CML patients treated with Novartis’ Glivec (imatinib) – which brought in $1.51 billion in sales last year – followed by a second generation TKI.
A phase I/II study looked at 500 patients with Ph+ chronic myelogenous leukemia previously treated with one prior TKI (Glivec) or more than one TKI – Glivec plus Bristol-Myers Squibb’s Sprycel (dasatinib) and/or Novartis’ Tasigna (nilotinib).
Major cytogenetic response (MCyR) at 24 weeks for patients previously treated with Glivec only was 33.8%, and 53.4% after a minimum follow-up of 23 months.
The McyR for those on Glivec and at least one other TKI was 26.9% (32.4% after 13 months).
This approval of Inlyta and Bosulif is particularly welcome for Pfizer, which last month suffered a blow when a phase III trial found that combining the manufacturer’s Torisel (temsirolimus) with Roche’s Avastin does not increase survival rates for advanced RCC patients.
Pfizer was hoping to increase its drug’s use by combining it with Avastin, but this now looks unlikely – earlier this year it also failed to beat Bayer’s RCC drug Nexavar in a head-to-head study.
Sutent for RCC is still going strong, garnering sales of $1.19 billion for 2011, overtaking the $1 billion sales from rival Nexavar.
However, stiff competition is coming from GlaxoSmithKline’s Votrient, which will usurp Sutent as the RCC market leader by 2016, according to analysts at Decision Resources.
Adam Hill
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