NORTH AMERICAN BUSINESS
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS
No Result
View All Result
NORTH AMERICAN BUSINESS
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS
No Result
View All Result
NORTH AMERICAN BUSINESS
No Result
View All Result
Home ALL Healthcare

US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for previously untreated metastatic bladder cancer

by Emma Jones
April 29, 2021
A A

Basel, 28 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favour of maintaining accelerated approval of Tecentriq® (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumours express high levels of PD-L1 (PD-L1–stained tumour-infiltrating immune cells covering ≥5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts though the recommendations are not binding. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

“Today’s positive vote reaffirms that Tecentriq fills a significant unmet need for people with previously untreated metastatic bladder cancer, many of whom cannot tolerate standard of care chemotherapy and need additional options,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Having now received positive ODAC recommendations in both bladder cancer and triple-negative breast cancer, we will continue to work with the FDA on next steps for Tecentriq in these indications.”

The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, with specific postmarketing requirements (PMRs) to confirm the clinical benefit and convert to regular approval.

Tecentriq was granted accelerated approval in 2017 for the treatment of adults with locally advanced or mUC who are not eligible for cisplatin-containing chemotherapy based on the positive overall response rate and duration of response results from the IMvigor210 study. Tecentriq’s indication was subsequently focused on PD-L1 high patients, who would benefit the most based on findings from the IMvigor130 study in 2018. This Phase III trial is the designated PMR for the first-line mUC indication and met its co-primary endpoint of progression-free survival. IMvigor130 continues for overall survival (OS). Roche looks forward to sharing the final OS results once available.

Roche remains committed to following the science to better understand cancer, including which patients may benefit most from immunotherapy treatment. Tecentriq has already demonstrated its transformational role in areas of high medical need and is a first in class medicine approved for particularly difficult to treat cancers. Tecentriq’s extensive development programme includes multiple ongoing and planned Phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings.

Yesterday, on 27 April, the ODAC voted 7 to 2 in favour of maintaining the accelerated approval of Tecentriq in combination with nab-paclitaxel for the treatment of people with PD-L1-positive, metastatic triple-negative breast cancer.

Tags: < Market
ShareTweetShareSend

Related Industries

Healthcare

Boston Scientific Announces Agreement to Acquire Relievant Medsystems, Inc.

September 20, 2023
Healthcare

BD Ranks in Top 10 for Transparency, Awarded Best Code of Conduct in 2023 U.S. Transparency Awards

September 20, 2023
Healthcare

Celanese Announces Agreement with the Population Council for Sustained Release Dual-API Therapeutic

September 13, 2023
Healthcare

Thermo Fisher Scientific and National Minority Quality Forum Collaborate to Make Clinical Research More Accessible to Historically Underserved Communities

September 8, 2023
Healthcare

Abbott to Acquire Bigfoot Biomedical, Furthering Efforts to Develop Personalized, Connected Solutions for People with Diabetes

September 6, 2023
Healthcare

AMGEN AND HORIZON THERAPEUTICS PLC RESOLVE FTC LAWSUIT, CLEARING PATH TO CLOSE ACQUISITION

September 2, 2023

BMW, Ford and Honda Agree to Create ChargeScape, a New Company Focused on Optimizing Electric Vehicle Grid Services

September 13, 2023

...

Apple unveils its first carbon neutral products

September 13, 2023

...

Dow collaborates with LanzaTech to launch readily bio-degradable cleaning solution that utilizes circular carbon capture

September 30, 2023

...

Enabling low-carbon ammonia: our landmark agreement with CF Industries

September 12, 2023

...

Honeywell Partners With National Renewable Energy Lab On Hydrogen Fuel Storage

September 13, 2023

...

AMGEN AND HORIZON THERAPEUTICS PLC RESOLVE FTC LAWSUIT, CLEARING PATH TO CLOSE ACQUISITION

September 2, 2023

...

DuPont Names Recipients of 2023 Lavoisier Medal and Pedersen Award

September 8, 2023

...

Hilton to Install Up to 20,000 Tesla Universal Wall Connectors at 2,000 Hotels, Creating Largest Overnight Electric Vehicle Charging Network within Hospitality Industry

September 8, 2023

...

Amazon Announces Supply Chain by Amazon, Offering Sellers End-to-End Supply Chain Management Across All Sales Channels

September 13, 2023

...

NORTH AMERICAN BUSINESS (www.na-biz.com) is a leading source of business and corporate news, information, industry trends, market updates and insights across a broad spectrum of industries in North America and worldwide.

MENU

  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS

CONTACT US

EDITORIAL:     editor#na-biz.com

PARTNERSHIP:     biz#na-biz.com

HUMAN RESOURCE:     hr#na-biz.com

* (replace # with @)

  • Official Site

Copyright © NORTH AMERICAN BUSINESS All rights reserved.

No Result
View All Result
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS

Copyright © NORTH AMERICAN BUSINESS All rights reserved.