Bloomberg News (2/9, Edney, Larkin) reported that the Food and Drug Administration on Friday announced it has approved Celgene's multiple-myeloma therapy, Pomalyst (pomalidomide). The FDA's Office of Hematology and Oncology Products Director Dr. Richard Pazdur explained that multiple-myeloma therapies are "tailored to meet individual patient's needs, and today's approval provides an additional treatment option for patients who have not responded to other drugs." The agency approved the drug's use for patients with multiple myeloma in whom "at least two other drugs" - including the company's own Revlimid (lenalidomide) and Takeda Pharmaceutical's Velcade (bortezomib) - have been ineffective.
Reuters (2/9, Clarke) added that the FDA approval came with two stipulations: For one, the agency is requiring that the Summit, New Jersey-based pharmaceutical company include a boxed warning on Pomalyst's labeling, cautioning patients and healthcare providers that the medication could increase the risk for blood clots, and advising that pregnant women refrain from using the drug because it can lead to life-threatening birth defects. In addition, the FDA is limiting the product's availability to prescribers, who have been certified through the Pomalyst Risk Evaluation and Mitigation Strategy (REMS). Reuters noted that the similar stipulations were tied to the agency's approval of Revlimid.