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Supplemental NDA Submitted for Oxaliplatin as Adjuvant Treatment for Colon Cancer

PARIS, Jan. 19 /PRNewswire/ -- Sanofi-Synthelabo announced today that it has submitted a supplemental New Drug Application (sNDA) in the United States and an extension of indication in Europe with France as Reference Member State for ELOXATIN(TM) (oxaliplatin for injection) in the adjuvant treatment of patients with colon cancer.

Adjuvant therapy is a treatment following surgery, with the goal of eradicating any remaining cancer cells, and increasing the cure rate. In fact, adjuvant therapy offers promise for not just extending patients lives, but helping to assure full recovery without recurrence of cancer.

"Few treatment options exist for colon cancer in adjuvant setting. The submission for ELOXATIN(TM) in this indication will allow to extend patients benefit to early stages and therefore curable stages of the disease," said Professor Aymery DE GRAMONT, Head of Oncology Division at Saint-Antoine Hospital, Paris. "The major reduction in disease recurrence obtained with ELOXATIN(TM) in the adjuvant setting will significantly impact the treatment of early stages of the disease, especially the ones with lymph nodes involvement."

Efficacy results of the Multicenter International Study of Oxaliplatin/5- Fluorouracil/Leucovorin (5-FU/LV), in the Adjuvant Treatment of Colon Cancer (MOSAIC) were presented at the 39th annual meeting of the American Society of Clinical Oncology (ASCO) in June 2003. This pivotal trial showed that the addition of ELOXATIN(TM) to the current standard of post-operative (adjuvant) chemotherapy (5FU/LV) for colon cancer, reduces the risk of recurrence by 23% (p ELOTAXIN(TM) Status
ELOXATIN(TM) received marketing approval in France for the 2nd line treatment of metastatic colorectal cancer in April 1996, and as a 1st line treatment in April 1998. In July 1999, ELOXATIN(TM) was approved for the 1st line treatment indication in major European countries, through a mutual recognition procedure, France being the Reference Member State.

ELOXATIN(TM) has successfully completed a Mutual Recognition Procedure in Europe in December 2003, which will allow the product to be indicated for the full indication: "Treatment of Metastatic Colorectal Cancer in combination with 5-fluorouracil and folinic acid" (i.e. 1st line and 2nd line treatment).

In the US, ELOXATIN(TM) has been approved on January 9, 2004, for the first line treatment of metastatic carcinoma of the colon or rectum, after an approval in August 2002 for second line treatment of patients. This new approval recommends now the use of ELOXATIN(TM), in combination with infusional 5FU/LV, for the treatment of advanced carcinoma of colon or rectum in the US.

Colorectal Cancer Leading Cause of Death
About one million new cases of colorectal cancer are diagnosed worldwide every year, and about 150,000 new cases in the U.S. According to the American Cancer Society, colorectal cancer is the second leading cause of malignancy- related death in the U.S., accounting for 10 to 15% of all cancer death. Over a lifetime, about one in 18 people develop colorectal cancer, and, each year, about 56,000 people die from it in the U.S.

Clinical Considerations about ELOXATIN(TM) in the United States
In the United States, ELOXATIN(TM) (oxaliplatin for injection), used in combination with infusional 5-fluorouracil (5-FU) and leucovorin (LV), is indicated for the treatment of advanced carcinoma of the colon or rectum.

ELOXATIN(TM) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.

Anaphylactic-like reactions to ELOXATIN(TM) have been reported, and may occur within minutes of ELOXATIN(TM) administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms.

ELOXATIN(TM) should not be administered to patients with a history of known allergy to ELOXATIN(TM) or other platinum compounds.

Women of childbearing potential should be advised not to become pregnant while receiving treatment with ELOXATIN(TM).

ELOXATIN(TM) is associated with pulmonary toxicity, which may be fatal, and with two types of primarily peripheral sensory neuropathy: an acute, reversible type of early onset and a persistent type (>14 days). Paresthesias (all grades) occurred in 77% of previously untreated patients. Acute and persistent neuropathies occurred in 56% and 48% (all grades) of previously treated patients, respectively. An acute syndrome of pharyngolaryngeal dysesthesia seen in 1%-2% (grade 3/4) of patients, characterized by subjective sensations of dysphagia or dyspnea, without any laryngospasm or bronchospasm (no stridor or wheezing), may also occur.

Both 5-FU and ELOXATIN(TM) are associated with gastrointestinal and hematologic adverse events. When ELOXATIN(TM) is administered in combination with 5-FU, the incidence of these events is increased.

Full prescribing information including boxed warning is available upon request.

Source: Sanofi-Synthelabo

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