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  • Home > Blog > Treatment News > Chemotherapy Drug Earns FDA Orphan Drug Designation for Malignant Pleural Mesothelioma
Posted on Friday, Jan 20, 2012

Chemotherapy Drug Earns FDA Orphan Drug Designation for Malignant Pleural Mesothelioma

In a press release earlier this month, a Japanese bio-pharmaceutical company announced it has been granted orphan drug designation by the U.S. Food and Drug Administration for its drug CBP501.  The chemotherapy drug by CanBas Co., Ltd has been approved “for use in combination with cisplatin and pemetrexed for treatment of patients with mesothelioma.” 

Malignant pleural mesothelioma, a rare cancer caused by exposure to asbestos, is one of the nearly 7,000 diseases designated as rare, or “orphan,” in the United States.  An orphan disease status is assigned to a disease or disorder if it affects fewer than 200,000 Americans at any given time.  Mesothelioma is incurable, but is often treated with a combination of surgery, chemotherapy and radiation. 

CBP501, a synthetic peptide, has been found to increase the effectiveness of cisplatin as it accumulates in mesothelioma tumors.  Cisplatin is typically administered in combination with pemetrexed in patients with mesothelioma. 

Nicholas J. Vogelzang, MD, Chair and Medical Director of the Developmental Therapeutics Committee of US Oncology Research, offered in a presentation entitled “Contemporary Treatment of Malignant Pleural Mesothelioma” that CBP501 “enters cells rapidly [and] increases the cytotoxicity of DNA-damaging anticancer drugs against cancer cells without increasing adverse effects.”  He suggested that clinical trials of triplet therapy using pemetrexed, cisplatin and CBP501 would be a critical step for proving the drug’s effectiveness.

Currently, a randomized clinical trial is underway comparing the results of patients with advanced malignant pleural mesothelioma in the U.S., Russia and Argentina treated with the chemotherapy drugs cisplatin/pemetrexed with and without the addition of CBP501. 

Through the FDA, a pharmaceutical company developing a drug to treat an orphan disease can be granted with an orphan designation.  Alimta (pemetrexed), distributed by Eli Lilly and Company, is designated as an orphan drug.  It was the first drug approved for mesothelioma treatment.

Most recently, Pinnacle Biologics was granted orphan drug designation for its product PHOTOFRIN® (porfimer sodium) as adjuvant therapy to surgery in the treatment of malignant pleural mesothelioma.

To find out more about CBP501 see CanBas’ website.