Topics:

Pfizer's Bosulif set for greater sales with EMA approval

Tools

Pfizer ($PFE) has extended the run of good news for its focus on targeted cancer treatment with a positive recommendation from EU regulators for Bosulif. The nod sets the stage for another approval and greater sales of the leukemia drug.

The European Medicines Agency (EMA) supported the use of Bosulif for patients with Philadelphia chromosome positive chronic myelogenous leukemia who have failed treatment with other kinase inhibitors for the rare form of leukemia. EU approvals usually follow within a couple of months of EMA recommendations. The FDA approved the cancer treatment in September, prompting analysts to estimate that Pfizer could generate $341 million in U.S. annual sales by 2016.

Novartis' ($NVS) Gleevec, the first drug in the same class as Bosulif, is the typical first-line therapy. The treatments work by inhibiting an enzyme called tyrosine kinase. But patients often become resistant to Gleevec, which is why second-line therapies such as Bosulif are increasingly important. Bristol-Myers Squibb's ($BMY) Sprycel and Novartis' Tasigna are other second-line CML drugs.

These kinds of targeted therapies are a hot area right now because they can narrow the treatment options for some patients, avoiding ones that probably won't work. Pfizer has moved three targeted cancer treatments through the FDA--Bosulif, lung cancer drug Xalkori, and its kidney cancer drug Inlyta. Investors like their potential because while patient pools are smaller, their price tags are higher. But that in itself has created some issues. The EU also has approved Inlyta, but the U.K.'s drug price watchdog NICE recommended against it in December, saying its price of £3,517 ($5,660) for 56 5-milligram Inlyta tablets was too high.

- here's the EMA recommendation (pdf)
- see Pfizer's release

Related Articles:
Pfizer, Novartis win EU nods for new leukemia, eye drugs
Pfizer nabs another targeted cancer drug OK from FDA
NICE snubs Pfizer's Inlyta kidney cancer drug
Pfizer's targeted drug knocks out child cancers in small study
EU panel recommends Inlyta for adults with kidney cancer