FDA approves Novartis' Tasigna for Chronic Myeloid Leukemia

The U.S. Food and Drug Administration have granted approval to a new chemotherapy drug ‘Tasigna’, manufactured by Swiss drug giant Novartis AG, for treatment of chronic myeloid leukemia (CML) in patients who no longer respond to Glivec, also made by the pharmaceutical company Novartis.

Basel, Switzerland-based Pharmaceutical group Novartis said yesterday that the US federal agency has given approval for the oral treatment Tasigna that can be used to treat patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), a lethal blood cancer that's one of the four most common types of leukemia, and affects about 4,500 people in America every year.

The drug is approved especially for use in patients who are resistant or intolerant to prior treatment, including Novartis' Glivec, another drug considered as established treatment standard to treat the leukemia, a form of blood cancer. Glivec is known as Gleevec in the United States.

"Tasigna represents an important advance for the small number of patients who are resistant or intolerant to prior therapy," said David Epstein, president and chief executive of Novartis Oncology. "This approval means we can offer physicians a comprehensive treatment approach with effective medicines to treat their Ph+ CML patients."

The multinational pharmaceutical company-Novartis AG said it will make Tasigna available throughout the country within days. The company hopes Tasigna could bypass Glivec, Novartis' second-biggest seller last year with sales of $2.6 billion, in terms of sales.

Novartis also hopes that sales of both of its drugs, Glivec and Tasigna, could be more than $3.5 billion in a year.

This second-line drug Tasigna, known generically as nilotinib, will face challenge from The New York City-based Pharmaceutical giant Bristol-Myers Squibb (BMS) Co's Sprycel, which got FDA approval last year in June.

The US health watchdog FDA has granted accelerated approval for Sprycel (dasatinib) for patients with chronic myeloid leukemia, a rare cancer characterized by the uncontrolled growth of white blood cells, as well as for use in the treatment of adults who have Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL), a more serious form of leukemia.

Tasigna was approved in Switzerland in July 2007, and is expected to be approved in the European Union by the end of this year. In September, the Committee for Medicinal Products for Human Use (CHMP), which reviews medicines in Europe, issued a positive opinion regarding Tasigna, recommending the drug be approved. Tasigna was filed for approval in Japan in June.