FDA sends complete response letter to Spectrum on its Evomela

26 October 2015
fda-big

The US Food and Drug Administration has issued a complete response letter to Spectrum Pharmaceuticals (Nasdaq: SPPI) on Evomela (melphalan) to treat multiple myeloma.

Spectrum said the FDA “did not identify any clinical deficiency” in its filing, made last December. The company plans to meet with the regulator to obtain clarification on the letter. Evomela is a propylene glycol-free melphalan formulation. Spectrum says it has demonstrated bioequivalence to the standard melphalan formulation Alkeran in a Phase II study. It has been granted orphan drug designation by the FDA for its use as a high-dose conditioning regimen in patients with multiple myeloma having autologous stem cell transplant.

Rajesh Shrotriya said: "we will work swiftly with the FDA to address the...letter... [we] remain committed to bringing Evomela to the market."

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical