Tasigna v. Gleevec - WSJ article

[Guest guest]

By JEANNE WHALEN

Novartis AG's new leukemia drug, Tasigna, performed better than the company's

blockbuster Gleevec leukemia treatment in initial results of a clinical trial, a

finding that could help Novartis start positioning the newer drug to replace

Gleevec.

 

Gleevec is the company's second biggest selling drug, with revenue of $3.7

billion last year. But it will lose patent protection and face competition from

low-cost generic copies in 2015. If enough doctors decide that Tasigna is the

better treatment, Novartis could hold onto leukemia-drug sales longer because

Tasigna's patent won't expire till later.

 

The Novartis-financed study tested Tasigna against Gleevec in 846 patients who

were newly diagnosed with a form of blood cancer called chronic myeloid

leukemia. After a year of treatment, a blood test measuring the presence of the

disease showed a major drop in about twice as many of the patients who took

Tasigna, according to results of the study presented Tuesday at the American

Society of Hematology's annual meeting in New Orleans.

 

In about 80% of patients taking Tasigna and 65% of those taking Gleevec, a

chromosome indicating the presence of the disease disappeared from the bone

marrow. And more patients who took Gleevec—about 4% compared with less than

1%—progressed to an advanced stage of the disease.

 

Gleevec is known by the generic name imatinib. Tasigna's generic name is

nilotinib.

" The superior efficacy and favorable tolerability profile of nilotinib compared

with imatinib suggests that nilotinib may become the standard of care in newly

diagnosed CML patients, " the doctors who led the study wrote in an abstract

summarizing the results. The study is set to continue for several more years.

 

Gleevec has been on the market since 2001 and is considered one of the great

successes of modern cancer treatment. One study showed that about 89% of

patients taking the drug were still alive after five years, a remarkable result

for cancer treatment. There is little data yet on whether Tasigna actually

extends patients' survival, which is the most important outcome of any

treatment.

 

Novartis tried to design Tasigna to attack CML even more precisely than Gleevec

does. Both drugs work by binding to a pocket in an aberrant enzyme called

BCR-ABL that causes white blood cells to grow and divide uncontrollably. Tasigna

was designed to occupy that pocket more snugly and shut down the enzyme's

activity more fully.

 

Tasigna is already approved for sale in many markets for the treatment of CML

patients who are resistant to or intolerant of Gleevec. Novartis said it now

plans to ask regulators for permission to sell Tasigna for use in newly

diagnosed CML patients.

 

Feldman, a hematologist at New York Presbyterian Hospital who was not

involved in the new study, called the data " pretty compelling " and said Tasigna

should be " seriously considered " as a treatment for newly diagnosed patients.

 

Stone, a hematologist at Dana-Farber Cancer Center in Boston, called the

data " encouraging " but said he might want to see another year or more of data

before prescribing Tasigna instead of Gleevec to new patients.

 

Weiss, a pharmaceutical analyst at Bank Vontobel AG in Zurich, said that

because there is so much evidence that Gleevec extends survival—while there is

little yet for Tasigna— some doctors might be hesitant to switch to the newer

drug. Tasigna " needs to show that it's even better than Gleevec in survival

terms, " he said. " Do we see that with this data? No. Does the drug have the

potential to show that data? Yes. "

 

Also, when generic copies of Gleevec become available, they will be much cheaper

than the still-patented Tasigna, which can cost more than $40,000 a year. This

could give some healthcare payers pause about paying for Tasigna, Mr. Weiss

said.