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Presented by Martin Cohen, M.D. at the December 16, 2003 meeting of the Oncologic Drugs Advisory Committee

Presented by Martin Cohen, M.D. at the December 16, 2003 meeting of the Oncologic Drugs Advisory Committee. Lung Cancer Approvals. Treatment Setting No. of Approvals NSCLC 1st line 5 R NSCLC 2nd line 1 R NSCLC 3rd line 1 A SCLC 2nd line 1 R NSCLC Palliation 1 R

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Presented by Martin Cohen, M.D. at the December 16, 2003 meeting of the Oncologic Drugs Advisory Committee

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  1. Presented by Martin Cohen, M.D. at the December 16, 2003 meeting of the Oncologic Drugs Advisory Committee

  2. Lung Cancer Approvals Treatment SettingNo. of Approvals NSCLC 1st line 5 R NSCLC 2nd line 1 R NSCLC 3rd line 1 A SCLC 2nd line 1 R NSCLC Palliation 1 R A=accelerated; R=regular

  3. NSCLC Approved 1st Line Rx

  4. Vinorelbine vs 5-FU/LV

  5. Vinorelbine/cisplatin

  6. Gemcitabine/cisplatin

  7. Paclitaxel/cisplatin

  8. Docetaxel/cisplatin

  9. Docetaxel - 2nd line

  10. Gefitinib 3rd line 142 patients refractory to platinum and docetaxel randomized to 250 or 500 mg/day Overall RR 10.6% (95% CI 6%, 16%) RR higher in females, in nonsmokers and in patients with adenocarcinoma histology

  11. SCLC - Hycamtin vs CAV1st line responders who progressed >60 days after stopping Rx

  12. Porfimer sodium- Photofrin P-PDT vs. Nd:YAG laser therapy Patients with symptomatic obstructive bronchial lesions Used 5-6 point symptom severity rating scales for dyspnea, cough and hemoptysis Comparable efficacy results

  13. NSCLC Approval Endpoints 1st line-Superior survival (3), Non-inferior survival (1), Superior TTP & RR with a survival trend (1) 2nd line-Superior survival (1) 3rd line-RR (1) Other - Symptom palliation (1)

  14. SCLC Approval Endpoints 2nd line - RR (1)

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