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Pfizer Breast Cancer Drug Could Fill Void Left By Avastin Withdrawal

 
• By Shirley Haley

Pfizer’s novel oral CDK 4/6 inhibitor PD-03392991, in combination with letrozole, delivered a statistically and clinically significant increase in median progression-free survival for women with advanced ER+/HER2- breast cancer, according to interim Phase II data presented Dec. 5 at the San Antonio Breast Cancer Symposium.

SAN ANTONIO – Pfizer Inc. is headed into Phase III testing with a novel cell synthesis blocking agent that worked in combination with aromatase inhibitor letrozole in Phase II to increase progression-free survival for a group of postmenopausal women with advanced estrogen receptor-positive/human epidermal growth factor receptor 2-negative breast cancer, the company reported Dec. 5 at the San Antonio Breast Cancer Symposium.

Women treated with PD-03392991 plus letrozole (Novartis AG’s Femara and generics) had a median progression-free survival of 26.1 months,...

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Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

Future Of US FDA’s Diversity Action Plan Guidance ‘Up In The Air’ As Statutory Deadline Looms

 
• By Sue Sutter

A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.

Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By Kate Rawson

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

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UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 
• By Eliza Slawther

The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.