Sarah, you must have missed the earlier posts. Phil was very active in trying to get TDM1 approved as early as possible.
This is what frustrates Phil:
Quote:
August 27, 2010
Genentech Receives Refuse to File Letter from FDA for T-DM1
– New BLA Expected to be Submitted in Mid-2012 –
WALTHAM, Mass.--(BUSINESS WIRE)--ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops antibody-based targeted anticancer products, today announced that Genentech, a member of the Roche Group, today announced its receipt of a Refuse to File (RTF) letter from the US Food and Drug Administration (FDA) for the accelerated approval of the Biologic License Application (BLA) for trastuzumab-DM1, or T-DM1, submitted in July 2010. Genentech also stated that as planned, it will continue with its ongoing Phase III registrational T-DM1 trial, known as EMILIA, and that it will continue to work with the FDA and expects to submit a new T-DM1 BLA in mid-2012.
Genentech noted that in its review of the BLA, the FDA stated that 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. Genentech re-affirmed its confidence in T-DM1 as “an important, novel HER2-targeted medicine,” and indicated that it remains fully committed to its ongoing development. In particular, as noted above, it intends to continue the EMILIA study which 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.
“It is a significant disappointment that there will be a delay in the opportunity for T-DM1 to be approved for patients with advanced HER2 positive breast cancer,” commented Daniel Junius, President and CEO of ImmunoGen. “In the meantime we continue to focus on the development of our robust and expanding pipeline as well as advancing our technology through new partnerships.”
The BLA submitted for T-DM1 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.
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I personally cannot accept the criteria for the delay - a new treatment cannot be approved because "all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population." To allow cancer patients to suffer and die because
all other treatments haven't been tried yet is inexcusable. Must patients suffer through toxic treatments that offer little effectiveness? I share Phil's outrage.
Adding new inexperienced personnel won't solve the issue. It is an engrained culture at the FDA complicated with the financial high stakes of approvals. As Phil has bitterly complained - it is a system that doesn't allow much input from patients.
Perhaps someone is finally listening to Phil's activism - and "fast track" is becoming a little faster.