Spectrum Pharma withdraws BLA for Rolontis

18 March 2019

Shares of Spectrum Pharmaceuticals (Nasdaq-GS: SPPI) dropped 8% in pre-market trading on Friday, after it revealed a further disappointment in the development of its lead product candidate Rolontis (eflapegrastim), a novel therapy for the management of chemotherapy-induced neutropenia in patients undergoing myelosuppressive chemotherapy.

Following a request from the US Food and Drug Administration for additional manufacturing-related information for Rolontis, the company has voluntarily withdrawn its Biologics License Application (BLA). Spectrum plans to resubmit a revised BLA as soon as possible. The stock recovered to some extents, closing down 2.9% at $9.98 on Friday.

The FDA did not cite concerns related to the pre-clinical and clinical modules of the BLA or the need for additional clinical studies. Spectrum’s decision to withdraw the BLA was the result of the company needing more time to provide certain additional manufacturing-related information, which was required before March 29, 2019, the day that the FDA’s initial 60-day review period ends.

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.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

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