Roche Delays U.S. Launch of Tecentriq SC Due to Manufacturing Process Updates

FDA was expected to make an approval decision on atezolizumab subcutaneous injection (Tecentriq SC) by next week. However, Roche now needs to update the manufacturing process of this drug, according to a securities filing on Thursday by its drug delivery technology partner, Halozyme Therapeutics.

Source: sec.gov

Halozyme said, "These updates are expected to be completed in 2023 and are expected to support the launch of Tecentriq SC in the United States in 2024."

A spokesperson for Genentech, a Roche subsidiary, told Fierce Pharma that Roche is making changes according to the evolving requirements of the FDA. The spokesperson confirmed that the company expects to receive FDA approval in 2024.

Last November, Roche submitted a marketing application for Tecentriq SC to the U.S. FDA and the European Medicines Agency. Their goal is to have the subcutaneous injection cover all approved indications of the intravenous formulation of Tecentriq. Last week, the UK’s regulatory authority approved the drug for marketing, marking the world's first approval of Tecentriq SC. Compared with the 30-60 minutes required for intravenous infusion, the subcutaneous injection of Tecentriq takes approximately only 7 minutes.

The FDA's amendment comments will not affect the supply of Tecentriq SC outside the United States, a Roche spokesperson said.

Despite the delay in its launch, Tecentriq SC may still be the first subcutaneously administered PD-1/L1 inhibitor to gain FDA approval.

New Anticancer Antibody Drug Approved for Intravenous Injection and Subcutaneous Formulation Under Development

Source: PharmaCube NextPharma, Drug Package Insert

Next up could be Merck's Keytruda. The completion date for the Phase III MK-3475-A86 trial comparing Keytruda subcutaneous injection to intravenous infusion for the treatment of non-small cell lung cancer was this April. However, Merck has not yet released the results.

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reprint, please leave a message to the WeChat Official Account or send a message, and include the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Highlights

Online Live Streaming & Offline Salon

↑ Long press to scan the QR code and register for the conference ↑