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IRESSA gefitinib Tablets Monotherapy for Recurrent Non-Small Cell Lung Cancer NSCLC

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IRESSA gefitinib Tablets Monotherapy for Recurrent Non-Small Cell Lung Cancer NSCLC

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    1. IRESSA® (gefitinib) Tablets Monotherapy for Recurrent Non-Small Cell Lung Cancer (NSCLC) Oncologic Drugs Advisory Committee Meeting March 4, 2005

    2. Introduction and Regulatory History Mark Scott, PhD US Development Leader, IRESSA®

    3. Context for Today’s Meeting Prior ODAC discussions regarding Subpart H approvals Need for rapid completion of post-approval trials What if a post-approval trial does not meet its primary endpoint? How much weight should be given to one trial, when several are ongoing?

    4. Why We Are Here Today Communicate outcomes of Trial 709 Describe actions taken on implications of Trial 709 outcomes Provide clinical interpretation Summarize ongoing development Outline FDA submission timings

    5. Agenda

    6. Experts Available for Q&A AstraZeneca Staff Alan Barge, MD Nick Botwood, MD Kevin Carroll, MSc Carolyn Fitzsimons, MBA Renee Iacona, PhD Judith Ochs, MD Alex Oldham, PhD Patricia Palumbo, BSN, JD Ann Readman, PhD Mark Scott, PhD External Physicians Howard Burris, MD Mark Kris, MD

    7. Lung Cancer in the US Leading cause of all cancer deaths 170,000 patients per year with 160,000 deaths annually Only 1/3 are diagnosed at an early stage Median survival in advanced disease <1 yr Symptoms are a major component of the disease

    8. Treatment Options for Advanced NSCLC Prior to Subpart H Approval for IRESSA® Response rates: 25%-45% Median survival: 8-10 mo TTP: 4 mo

    9. IRESSA® Development Strategy—NSCLC Prior to Subpart H Approval for IRESSA®

    10. IDEAL Trials: IRESSA® Monotherapy (N = 416) IDEAL I Overall response rate 19% IDEAL II Overall response rate 10.6% Higher rates in females, never smokers, adenocarcinoma histology, and Asians No differences between doses in efficacy Greater number of adverse events at 500-mg dose Highly acceptable safety profile at 250-mg dose

    11. Regulatory and Clinical Events 9/2002 – ODAC recommended accelerated approval under Subpart H 5/2003 – IRESSA® granted Subpart H approval Refractory to both docetaxel and platinum 7/2003 – Post-approval trials started

    12. Subpart H Commitments Trial 709 – IRESSA® vs. placebo Survival improvement Trial 721 – IRESSA® vs. docetaxel Non-inferiority design for survival 700/1440 patients randomized Trial 710 – IRESSA® vs. placebo Symptoms improvement Closed 9/04 in agreement with FDA

    13. Other Post-Approval Commitments SWOG 0023 – Maintenance Phase III, IRESSA® vs. placebo in patients with inoperable locally advanced Stage III NSCLC 259/672, reporting in 2008 BR19 – Adjuvant Phase III, IRESSA® vs. placebo in completely resected Stage IB, II and IIIA NSCLC 457/1242, reporting in 2008

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