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当前位置:药品说明书与价格首页 >> 抗肿瘤药 >> 新药动态 >> 英国批准千年公司多发性骨髓瘤治疗药Velcade上市

英国批准千年公司多发性骨髓瘤治疗药Velcade上市

——英国批准千年公司多发性骨髓瘤治疗药Velcade上市

2005-10-08 11:19:33  作者:新特药房  来源:中国新特药网天津分站  浏览次数:96  文字大小:【】【】【

新华社信息北京6月4日电据海外媒体报道,英国已批准千年制药公司的Velcade(bortezomib)注射液用于先前至少已经接受过两种疗法的治疗并在最后一次治疗后,疾病出现进展的多发性骨髓瘤。

Bortezomib是一种蛋白酶体抑制剂,能够特异性抑制哺乳动物细胞内26S蛋白酶体的类胰凝乳蛋白酶(chymotry in-like)活性,对细胞内一连串的信号发送产生影响,最终导致癌细胞死亡。

 

美国食品和药物管理局(FDA)已于2003年5月批准该药用于多发性骨髓瘤的治疗。

 Velcade (Bortezomib)

 

Developed by Millennium Pharmaceuticals

The First In A New Class of Cancer Drugs, Proteasome Inhibitors
 
Velcade, The First In A New Genre of Cancer Drugs, Has a Broad Range of Uses in the Treatment of Multiple Myeloma.

The Targeted Drug May Be Used to Treat Newly-Diagnosed Myeloma, and to Treat Myeloma that has Failed to Respond to Other Therapies. Velcade Has Produced Clinical Responses in Patients whose Cancer Progressed after Prior Treatment with the Drug, as well as Patients who have Failed to Respond to Several Other Treatments.

Velcade Also has Provided a Critically-Needed Alternative to High-Dose Chemotherapy Treatment.  High-Dose Chemotherapy Has Been Established As The Most Effective Treatment For Myeloma, But Most Patients Cannot Withstand Its Debilitating Side Effects.

Ongoing Research Trials Are Now Evaluating Velcade In Combination With Revlimid, Another Targeted Drug For Myeloma.  Findings of A Phase I Clinical Trial Indicated the Two Targeted Drugs May Be More Effective In Combination Than As Single Agents.


 An Alternative To High-Dose Chemotherapy

Velcade Has Emerged As The Recommended Treatment In Most Cases of Multiple Myeloma.

High-Dose Chemotherapy Has Proven To Be The Most Effective Treatment For Myeloma, But Most Elderly Patients Cannot Tolerate The Debilitating Treatment.  The Vast Majority of Myeloma Patients are Older than 65 and Therefore are Unable to Tolerate the Highly Aggressive Treatment.

To Avoid The Life-Threatening Side Effects Produced By High-Dose Chemotherapy, Velcade and Other Less Toxic Drugs Are Prescribed For  Elderly and Critically Ill Patients.

Anti-Cancer Effects

Velcade Belongs to a New Class of Cancer Drugs Known as Proteasome Inhibitors.

Proteasomes are Enzymes that Help Regulate Cell Function and Growth. Their Main Function is to Degrade Unneeded or Damaged Proteins. In Essence, Proteasomes Serve as a "Garbage Disposal" for Unneeded Proteins.

Velcade Restricts the Activity of Proteasomes, Disrupting Normal Cellular Function.   Without the Ability to Dispose of Damaged Proteins, Malignant Cells are Unable to Proliferate.
 

Authorized Uses

Velcade Became the First Targeted Drug Approved for the Treatment of Multiple Myeloma in 2003.

The Newly-Developed Drug was Authorized for the Treatment of Myeloma that had Failed to Respond to Two Prior Therapies.  Velcade was the First Treatment Approved for Multiple Myeloma in More than a Decade.

The Anti-Cancer Agent was Subsequently Authorized in 2006 for the Treatment of myeloma that Progressed After one prior Therapy.

Velcade received Approval  as an Initial Treatment for Myeloma In 2008.

The Target Drug Also Has Been Authorized For The Secondary Treatment of Mantle Cell Lymphoma.
 

Research Findings: Phase III Trial

The effectiveness of Velcade as an Initial Treatment for Multiple Myeloma was Confirmed in an International Research Trial.

The Phase III Clinical Trial, Conducted at 151 Cancer Centers in 22 Nations, Concluded Prematurely Because Treatment with Velcade Was Clearly Superior. 

Velcade, Used in Combination with Melphalan and Prednisone, Surpassed the Performance of Standard Chemotherapy with Melphalan and Prednisone.

The Two Treatment Regimens were Evaluated in 682 Myeloma Patients who were Ineligible for High-Dose Chemotherapy.  Most Patients Enrolled in the Multi-national Trial were Older than 74, and Therefore Unable to Tolerate the Debilitating Treatment.

The Velcade-Melphalan-Prednisone Combination was Administered to 344 Patients. The Remaining 338 Patients Received Standard Chemotherapy, Combining Melphalan and Prednisone.

Research Findings, Published in the New England Journal of Medicine on August 28, 2008,  Noted That "the  Response was More Rapid and Durable in the (Velcade) Group than in the Control Group."

The Risk of Death and Recurrence was Significantly Diminished By Treatment with Velcade.  Rates of Remission also were Substantially Higher in Patients who Received the Targeted Drug.

Treatment with Velcade Reduced the Risk of Death by Nearly 40 Percent.  Only 45 Patients who Received Velcade Died Within 16 Months of the Completion of  their Treatment.  In Comparison, 76 Patients Treated with Standard Chemotherapy Died.

The Velcade Regimen Produced Complete or Partial Remission in 71 Percent of Patients.  In Contrast, 35 Percent of Patients Treated with the Melphalan-Prednisone Combination Entered Complete or Partial Remission.

A Significantly Higher Percentage of Patients Treated with Velcade had no Evidence of Cancer after the Completion of their Treatment.  Complete Remission Developed in 30 percent of Patients Treated with the Velcade regimen. Only Four Percent of the Control Group Entered Complete Remission.

Patients Treated with Velcade Remained in Remission for a Median of 19.9 Months.  In Comparison, Patients who Received Standard Chemotherapy Remained in Remission for a Median of 13.1 months.

Treatment with Velcade Increased the Time until Cancer Progressed  by 52 Percent. Velcade Delayed the Progression of Cancer for a Median of 24 Months. Compared to  16.6 Months For Standard Chemotherapy.


Side Effects

The Velcade Regimen did not Increase Treatment-Related Morality in The Phase III Clinical Trial. Research Analysis Concluded that the "Rate of Death during Treatment was Low in Both Groups, as Compared with Historical Data on Early Mortality Among Elderly Patients."

Treatment-Related Deaths were Reported in Two Percent of Patients in the Velcade Group and one Percent of Patients in the Control Group.

Severe Complications were more Common in Patients Treated with Velcade.  Serious Side Effects Developed in 46 Percent of Patients Treated with Velcade, and in 36 percent of Patients who Received the Melphalan-Prednisone Combination.

The Development of Side Effects Led to the Discontinuation of Treatment in 50 Patients (15 Percent) in the Velcade Group, and 47  Patients (14 Percent) in the Control Group.

The Most Common Adverse Effect Produced by Velcade was Pain or Numbness in the Hands or Feet, Referred to as Peripheral Neuropathy. The Side Effect Developed in 43 Patients in the Velcade Group and 16 Patients in the Control Group.

Gastrointestinal Complications also were More Common in Patients who Received Velcade.  Gastrointestinal Symptoms Developed in 19 Percent of Patients Treated with Velcade and 5 percent of Patients who Received Standard Chemotherapy.

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