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Shakun Malik, Ann Farrell, Xu, Qiang (Casey), Rajeshwari Sridhara, Robert Justice,

Poor Representation of Women, Older Age groups and Minorities in US Approval Trials for Non-Small Cell Lung Cancer: FDA Review. Shakun Malik, Ann Farrell, Xu, Qiang (Casey), Rajeshwari Sridhara, Robert Justice, Richard Pazdur

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Shakun Malik, Ann Farrell, Xu, Qiang (Casey), Rajeshwari Sridhara, Robert Justice,

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  1. Poor Representation of Women, Older Age groups and Minorities in US Approval Trials for Non-Small Cell Lung Cancer: FDA Review Shakun Malik, Ann Farrell, Xu, Qiang (Casey), Rajeshwari Sridhara, Robert Justice, Richard Pazdur Center for Drug Evaluation and Research, Office of Oncology Drug Products, FDA

  2. We reviewed trial data submitted to the FDA for drug approvals for the treatment of NSCLC over the last decade (2000- 2010). The purpose of this review was to note if the trial populations studied represented the US population who were to receive these drugs. We analyzed the gender, age, and ethnicity data from ten pivotal trials.

  3. Despite a decrease in the overall lung cancer death rate, reports of disparity by gender, age, and race persist. • According to Surveillance, Epidemiology, and End Results (SEER Data) of the patients diagnosed with lung cancer • 58% are men and 42% are women, • 27 % are < 65 years of age, and 73% are > 65. • The median age at diagnosis is 71 years.

  4. Compared to Caucasians with incidence rate of 68 per 100,000, the incidence is 72.7 per 100,000 for African Americans. • The incidence is especially alarmingly high for African American males at 126.8 per 100,000. • Incidence for Hispanics is 30.8/100,000 • and Asians 39 per 100,000.

  5. Results Incidence Trial enrollment

  6. Results Incidence Trial enrollment

  7. Results Incidence Trial enrollment

  8. Conclusions Our results suggest that the trial populations used for approvals do not represent well the US population who may receive the marketed agent. Women, the elderly, and minorities were less frequently enrolled in the trials. The Disparities by age and ethnicity were especially pronounced.

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