Genentech, a member of the Roche Group, has received Refuse to File letter for accelerated approval for its Trastuzumab-DM1 (T-DM1) biologics license application (BLA) from US Food and Drug Administration (FDA).
Genentech is expected to continue with its ongoing Phase III registrational T-DM1 trial, Emilia and is also expected to work with the FDA and expects to submit a new T-DM1 BLA in mid-2012.
Following the results from a single-arm Phase II study which demonstrated T-DM1 decreased tumors in one-third of women with advanced HER2-positive breast cancer, who had received on an average seven prior medicines, including two HER2-targeted medicines, Genentech has submitted the BLA in July 2010 that has requested accelerated approval for T-DM1.
In response the FDA stated that T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population.
Genentech Product Development executive vice president and chief medical officer Hal Barron said that they firmly believe in the potential of T-DM1 as a new HER2-targeted option and remain fully committed to its ongoing development.
Genentech is expected to submit data from the amended Phase III randomised Emilia study to the FDA to support a new T-DM1 BLA in mid-2012.
Genentech's Emilia study is a comparative study between T-DM1 and Lapatinib in combination with capecitabine in people with advanced HER2-positive breast cancer whose disease has worsened after receiving initial treatment.