FDA rejects colorectal cancer treatment
IRVINE, Calif. The Food and Drug Administration has rejected the approval application for a drug to treat colorectal cancer.
Spectrum Pharmaceuticals announced Friday that the FDA had rejected its application seeking an additional approval for the drug Fusilev (levoleucovorin), as a treatment for advanced colorectal cancer. The drug already has approval for treating the bone cancer osteosarcoma.
In its complete response letter – which signifies a rejection – the FDA said Spectrum had not demonstrated that Fusilev was equal to or better than leucovorin. The company said it will meet with the FDA to discuss options for obtaining approval for Fusilev as a colorectal cancer treatment.
Several companies market leucovorin as a generic in injectable and tablet form; GlaxoSmithKline originally marketed it under the brand name Wellcovorin, though it no longer sells the drug.
Medco report: Specialty pharmacy spending driven by cancer drugs
FRANKLIN LAKES, N.J. Cancer drugs will become the biggest driver of specialty pharmacy spending, with global sales of the drugs expected to reach $80 billion by 2012, according to a new report by pharmacy benefit manager Medco Health Solutions.
Spending on cancer drugs increase by 15.1% last year – behind autoimmune disorder and multiple sclerosis drugs – with an overall contribution to drug spending of 5% during the first half of this year.
“Targeted cancer therapies have dramatically reshaped oncology and greatly benefited cancer patients,” Medco chief medical officer Robert Epstein said in a statement. “The newer cancer drugs improve survival rates since they target what fuels the cancer’s growth.”
Cancer drugs also represent a robust pipeline, with more than 800 under investigation. Many of the drugs that the Food and Drug Administration has approved in the last four years – often biotech drugs – have cost $20,000 for 12-week courses of therapy, while some have cost $10,000 a month, though the report said a regulatory approval pathway for biosimilars could help reduce the costs of biotech drug treatments.
Kinney Drugs to purchase Vermont retail pharmacy
GOUVERNEUR, N.Y. A regional retail pharmacy chain in northern New York state will purchase a locally owned store in Vermont.
Kinney Drugs announced Wednesday that it would purchase Vincent’s Drug & Variety, in Waterbury, Vt. The purchase is expected to take place in early January 2010.
“Everyone at Kinney Drugs is excited at the prospect of welcoming Vincent’s Drug employees and customers into our family,” Kinney Drugs president and COO Bridget-ann Hart said in a statement. “It is important to us that this transition be as smooth as possible for both Vincent’s Drug customers and its employees.”
Vincent’s Drug & Variety has been in Waterbury for 98 years.
“The values, health programs and services and community involvement of our two companies are very much aligned,” owner and pharmacist John Vincent said in a statement. “I wholeheartedly trust the people of Kinney Drugs to provide the same level of caring that Washington County has become accustomed to from Vincent’s Drug & Variety.”