FDA approves injectable prostate cancer treatment
ROCKVILLE, Md. The Food and Drug Administration has approved an injectable drug for treating prostate cancer.
The FDA said in a statement Monday that Ferring Pharmaceuticals’ degarelix is the first drug to treat prostate cancer in several years. It belongs to the gonadotropin releasing hormone receptor inhibitor class of drugs, which slow the growth and progression of prostate cancer by suppressing testosterone.
“Prostate cancer is the second leading cause of cancer death among men in the United States, and there is an ongoing need for additional treatment options for these patients,” said Richard Pazdur, director of the Office of Oncology Drug Products at the FDA’s Center for Drug Evaluation and Research.
Ferring, based in Parsippany, N.J., has not issued a brand name for the drug.
European Commission approves marketing of Celgene drug
BOUDRY, Switzerland The European Commission has approved the marketing of a cancer drug by Celgene International Sarl, the Swiss biotech company announced Tuesday.
The company described Vidaza (azacitidine) as the first epigenetic cancer therapy to significantly extend survival for patients with intermediate-2 and higher-risk myelodysplastic syndromes and acute myeloid leukemia.
“The European Commission approval of Vidaza is recognition of the significant survival benefited afforded by this therapy for critical hematological malignancies,” Celgene Europe president Philippe Van Holle.
“We will now begin working with local regulatory authorities on a country-by-country basis for reimbursement and distribution for all European Union member states.”
Teva chief confident bill on follow-on biologics to appear in Congress
NEW YORK The chief executive officer of Teva North America is confident that a bill to create a regulatory pathway for follow-on biologics will appear in Congress next year, according to published reports.
Bill Marth, chief executive of Teva Pharmaceutical Industries? North America division, told Reuters Tuesday that there was a “very good chance” that Congress would introduce a bill to allow follow-on biologics, also known as biosimilars, in 2009.
Several large drug makers have already announced plans to create biosimilar divisions, including Merck & Co., Eli Lilly & Co. and AstraZeneca, which announced its own plan earlier this week.