Cancer Therapy

Tasigna (nilotinib) has received European Union approval as a new anti-cancer therapy for patients with a life-threatening form of leukemia who are resistant or intolerant to prior treatment including Glivec (imatinib).

The EU approval was supported by data showing that Tasigna produced a positive response in 49% of patients in the chronic phase of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). Most patients achieved this response within three months of starting Tasigna treatment.

"The approval of Tasigna gives us the opportunity to help more CML patients and, with Glivec as our first line agent, provide comprehensive treatment options for prescribers," said David Epstein, President and CEO of Novartis Oncology. "Tasigna drives home our commitment to develop compounds to fulfill unmet medical needs by pursuing indications for patients with limited treatment options."

The European Commission decision applies in all 27 EU member states plus Norway and Iceland, and follows recent approvals in the US and Switzerland.

Wyeth's TORISEL Receives European Commission Approval for the ...

COLLEGEVILLE, Pa., Nov. 26 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE) , announced today that the European Commission has approved TORISEL(TM) (temsirolimus) for the first-line treatment of patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors. TORISEL is the only approved cancer therapy that specifically inhibits the mTOR (mammalian target of rapamycin) kinase, an important regulator of cell proliferation, cell growth and cell survival. TORISEL was approved in the United States in May 2007 for the treatment of advanced RCC.

Renal cell carcinoma accounts for approximately 85 percent of the estimated 85,000 new cases of kidney cancer diagnosed in Europe annually. TORISEL is the only renal cancer therapy proved to extend median overall survival compared with interferon-alpha in patients with advanced RCC.

Moffitt Cancer Center Takes Part In Newly Published Study In This Week ...

The Moffitt Cancer Center said findings from the MM-009 Phase III trial show a statistically significant overall survival benefit for patients with multiple myeloma treated with REVLIMID plus dexamethasone. This study, along with another large, international trial evaluating REVLIMID, was published in this week's issue of the New England Journal of Medicine. In addition to increased survival, patients who received the oral cancer therapy in combination with the steroid dexamethasone also had increased response rates, time-to-disease progression and duration of response compared to patients treated with the steroid alone.

In the study, patients who received REVLIMID plus dexamethasone had an improved median overall survival time of 29.6 months compared to 20.2 months. The median time to progression was 11.1 months compared with 4.7 months in the placebo-dexamethasone group.