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AstraZeneca's Iressa Problem

In May of this year, two major scientific journals published papers correlating response to Iressa, AstraZeneca's targeted therapy for refractory non-small cell lung cancer, to a series of mutations clustered in a section of the EGFR gene. These widely publicized findings are fueling discussions that are bound to have consequences not only for AstraZeneca, patients and clinicians, but also for many pharmaceutical companies working on targeted therapies.

The effort to find and apply medically relevant biomarkers got a kick-start in Spring 2003 when The Boston Globe profiled the remarkable story of a Mrs. R, a 45-year-old nurse and mother who had been diagnosed in November 2002 with a fast-acting fatal form of lung cancer. Six months after diagnosis, following treatment with AstraZeneca PLC 's gefitinib (Iressa), she was not only surviving but in complete remission and living a nearly normal life.

Daniel Haber, MD, PhD, director of the Massachusetts General Hospital Cancer Center and chairman of the cancer genetics program at...

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 
• By Eliza Slawther

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.   

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.

In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

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Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By Lisa Takagi

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.

Rising Leaders 2025: Ovid’s Meg Alexander On Neurology’s Next Frontier

 
• By Jo Shorthouse

Ovid Therapeutics' president and COO Meg Alexander is leading the company’s strategic pivot toward innovative neurological treatments, potentially creating a new class of medicines for rare neurological disorders.

The Goldilocks Isotope: Perspective Therapeutics’ ‘Just Right’ Alpha Radiotherapeutic

 
• By David Wild

Thijs Spoor's bet on lead-212 is paying off as Perspective Therapeutics advances three clinical programs with promising early efficacy signals and a comprehensive manufacturing strategy.