FDA releases Alimta data

Tuesday's meeting of FDA's Oncologic Drugs Advisory Committee is likely to focus on FDA's skepticism about the strength of efficacy data supporting Alimta pemetrexed from Eli Lilly (LLY). LLY is seeking approval of Alimta as a single agent to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) refractory to chemotherapy. Alimta already is marketed in the U.S. in combination with cisplatin to treat patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. Alimta is under review for both pleural mesothelioma and NSCLC in Europe.

The pivotal study supporting LLY's sNDA compared overall survival following treatment with Alimta versus docetaxel in patients previously treated with chemotherapy. Although LLY asserts that its analysis demonstrates that the survival of Alimta-treated patients was non-inferior to docetaxel, FDA said the company used inappropriate statistical methods. According to FDA, the trial did not demonstrate non-inferiority. The agency added that "even if non-inferiority was demonstrated, however, it would not be credible because of imbalances in post-study chemotherapy." Thirty fewer patients received post-study chemotherapy in the docetaxel-treated group than in the Alimta group, FDA said. ...