Roche Holdings Ltd. (RHHBY) recently announced that the US Food and Drug Administration (FDA) refused to accept the company’s Biologics License Application (BLA) seeking accelerated approval for its breast cancer treatment trastuzmab-DM1 (T-DM1).
The BLA was submitted in July on the basis of mid-stage trial results. The data demonstrated that the candidate reduced the size of tumors in a third of women with advanced HER2-positive breast cancer. On an average, these women received seven treatments earlier.
The regulatory body did not accept the BLA because it believes that the patients in the phase II study had not tried all possible medications available for the treatment of metastatic breast cancer.
Roche is currently conducting a late-stage trial (EMILIA) with the candidate. The study is comparing T-DM1 with GlaxoSmithKline plc’s (GSK) lapatinib (Tykerb), which is administered in combination with capecitabine (Xeloda). The study is being conducted in women with advanced HER2-positive breast cancer, whose disease became worse after initial treatment.
Roche has an agreement with ImmunoGen Inc. (IMGN) for the global development of T-DM1 and the companies plan to file a new BLA with the FDA in mid 2012, which will be supported by the phase III (EMILIA) study.
We currently have a Zacks #3 Rank (short-term Hold rating) on Roche. We view the FDA’s rejection of Roche’s application for T-DM1 as a major setback for the company, which is already trying to cope with the negative results of Avastin in gastric and prostate cancer patients, discontinuation of development of ocrelizumab for rheumatoid arthritis due to an unfavorable risk-benefit profile and a delay in the development of type-II diabetes treatment, taspoglutide, due to a higher incidence of hypersensitivity reactions in late-stage trials.
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