Amgen Seeks Expanded Indication for Multiple Myeloma Drug

Amgen and its subsidiary, Onyx Pharmaceuticals, have submitted a supplemental New Drug Application (sNDA) to the FDA for their proteasome inhibitor, carfilzomib (Kyprolis), in the hopes of expanding the drug’s indication to include patients with relapsed multiple myeloma who have received at least 1 prior therapy.

Kyprolis was granted accelerated approval by the FDA in July 2012 for the treatment of multiple myeloma patients who have received at least 2 prior therapies, including bortezomib and an immunomodulatory agent, and whose disease has progressed on or within 60 days of completing a previous therapy. In addition to supporting the drug’s indication expansion, the recently submitted sNDA aims to convert its accelerated approval to full FDA approval.

The sNDA was submitted following positive results from a phase 3 trial that evaluated Kyprolis in combination with lenalidomide and low-dose dexamethasone, versus lenalidomide and low-dose dexamethasone alone, in patients with relapsed multiple myeloma following 1 to 3 prior treatment regimens.

An equivalent regulatory application for Kyprolis was filed in Europe.

“Multiple myeloma is an incurable blood cancer that often becomes resistant to treatment, underscoring the need for new therapeutic options that provide deep and durable responses to extend the time patients live without their disease progressing,” said Onyx Pharmaceuticals president Pablo J. Cagnoni, MD, in a press release. “The US and EU submissions support our goal of bringing Kyprolis to patients with relapsed multiple myeloma.”