Amgen submits sNDA to FDA for Kyprolis to treat relapsed multiple myeloma

The expanded indication of Kyprolis is for these patients who have received at least one prior therapy.

Currently, Kyprolis has accelerated approval in the US to treat patients with relapsed multiple myeloma as a monotherapy.

The sNDA is based on data from the global Phase III ENDEAVOR trial, which is the first of two head-to-head Phase III trials of Kyprolis versus Velcade (bortezomib).

Patients with relapsed multiple myeloma who were treated with Kyprolis and dexamethasone in the ENDEAVOR trial lived twice as long without their disease worsening, showing statistically and clinically significant superiority over Velcade.

Amgen Research and Development executive vice-president Sean Harper said: "Submission of this new sNDA for Kyprolis is important because if approved, it will mean more treatment options for patients with this serious disease.

"Multiple myeloma has historically been one of the most difficult to treat diseases because of the inherent complexities related to the recurring pattern of remission and relapse.

"The ENDEAVOR trial showed that patients who had failed at least one prior therapy were half as likely to see their disease worsen if they received Kyprolis.

"This is yet another data set that illustrates Kyprolis’ potential to extend the time patients live without their disease progressing and improve the depth and duration of a response."

The Kyprolis combination showed superiority over the Velcade combination for secondary objectives of higher overall response rate and lower neuropathy events.

The company noted that treatment discontinuation due to adverse events and on-study deaths was comparable between the two arms.

The rates of cardiac failure and renal failure for Kyprolis were comparable to those observed in the Phase III ASPIRE trial.

In the ENDEAVOR trial, the rates for cardiac and renal failure were higher in the Kyprolis arm versus the Velcade arm and there was also an increase in the incidence of hypertension and dyspnea in the Kyprolis arm compared to Velcade than that observed in the ASPIRE trial.

Based on the Phase III ASPIRE trial, the company continues to work with the FDA on the related sNDA in the US and with the European Union (EU) regulatory authorities for the Marketing Authorization Application for Kyprolis.

Following potential approval based on the ASPIRE trial, Amgen intends to submit ENDEAVOR for potential authorization in the EU.