Celgene Corporation announces that the US FDA has granted accelerated approval to its Supplemental New Drug Application (sNDA) for Thalomid (thalidomide) in combination with dexamethasone for the treatment of newly diagnosed multiple myeloma. The effectiveness of Thalomid is based upon response rates.
There are no controlled trials demonstrating a clinical benefit, such as an improvement in survival. Multiple myeloma is the second most common blood cancer in the United States affecting approximately 50,000 people.
Thalomid is available through a Thalomid Education and Prescribing Safety System, called S.T.E.P.S. Through the use of our S.T.E.P.S. programme, more than 130,000 US patients have had safe access to Thalomid since its market introduction in July 1998. This FDA approval for the indication of Thalomid in the treatment of newly diagnosed multiple myeloma allows physicians and their patients to be treated with another therapy option for this incurable blood cancer.
The safety profile for Thalomid in multiple myeloma has shown an increase in side effects with Thalomid and dexamethasone as compared to dexamethasone alone. The most common adverse events were constipation, sensory neuropathy, confusion, hypocalcemia, edema, dyspnea, thrombosis/embolism, and rash/desquamation, occurring in 20% of patients with a frequency less than or equal to 10% in patients treated with Thalomid/dexamethasone compared with dexamethasone alone.
"The approval of our sNDA represents a significant milestone for Celgene and an important step toward fulfilling our mission of making innovative treatment options available to patients with significant unmet medical needs," said Sol Barer, CEO at Celgene. "We are committed to the ongoing clinical development of our investigational therapies being studied in blood and solid tumour cancers, and we are proud that our efforts have resulted in this approval of Thalomid for use in combination with dexamethasone in newly diagnosed multiple myeloma patients," he added.