Genentech, a member of the Roche Group, announced the U.S. Food and Drug Administration (FDA) issued a Refuse to File letter for accelerated approval for the company’s trastuzumab-DM1 (T-DM1) Biologics License Application (BLA). As planned, Genentech will continue with its ongoing Phase III registrational T-DM1 trial, EMILIA. Genentech will continue to work with the FDA and expects to submit a new T-DM1 BLA in mid-2012.
The BLA submitted in July 2010 requested accelerated approval for T-DM1 based on the results of a single-arm Phase II study, which showed T-DM1 shrank tumors in one-third of women with advanced HER2-positive breast cancer, who had received on average seven prior medicines, including two HER2-targeted medicines.
Consideration by the FDA for accelerated approval requires recognition of a defined patient population of unmet need (a life-threatening disease with limited treatment choices), for whom a medicine’s early safety and efficacy data are reasonably likely to predict clinical benefit. Following the pre-submission meeting with the FDA in March 2010, Genentech concluded it was appropriate to submit a BLA for accelerated approval. In its review of the BLA, the FDA stated the 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.
“We firmly believe in the potential of T-DM1 as a novel HER2-targeted option and remain fully committed to its ongoing development,” said Hal Barron, M.D., executive vice president, Product Development and chief medical officer.
Genentech will submit data from the amended Phase III randomized EMILIA study to the FDA to support a new T-DM1 BLA in mid-2012. The EMILIA study compares T-DM1 to lapatinib in combination with capecitabine in people with advanced HER2-positive breast cancer whose disease has worsened after receiving initial treatment.
Date: August 27, 2010
Source: Genentech www.gene.com
Filed Under: Drug Discovery