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Genentech’s Hopes For Keeping Tecentriq Breast Cancer Claim May Rest With Trial In Early Disease Recurrence

 
• By Sue Sutter

Even though IMpassion132 is enrolling a different population and has a different chemotherapy backbone, it could confirm atezolizumab’s benefit for patients with advanced triple-negative breast cancer whose tumors express PD-L1, agency says ahead of advisory committee meeting on accelerated approval indications with failed confirmatory trials.

Breast cancer cell
Tecentriq's accelerated approval in triple-negative breast cancer is on the line. • Source: Alamy

An ongoing Phase III trial of Genentech, Inc. 's Tecentriq (atezolizumab) in patients who experienced early recurrence of triple-negative breast cancer after prior therapy could provide a pathway to confirming the PD-L1 inhibitor’s benefit in first-line TNBC, a current accelerated approval indication facing the threat of withdrawal.

On 27 April, the Food and Drug Administration’s Oncologic Drugs Advisory Committee will kick off three days of meetings on PD-1/L-1 inhibitor accelerated approval indications that have failed their confirmatory trials

First up to bat is Genentech, which is seeking to retain Tecentriq’s indication for use in combination with protein-bound paclitaxel for treatment of patients with unresectable

More from US FDA Performance Tracker

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

More from Regulatory Trackers

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

Global Pharma Guidance Tracker - March 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.