By Stefan F.
T-DM1 from ImmunoGen Inc. outperforms survival endpoint in Phase III trials.
A recent press release reports that the antibody-drug conjugate Trastuzumab Emtansine or T-DM1 has "significantly improved survival in the EMILIA Phase III Trial." This run of clinical trials was to establish the efficacy of T-DM1 in treating cases of metastatic HER-2 positive breast cancer. Patients enrolled on the trial had already been treated with taxane chemotherapy and Herceptin.
A large number of US breast cancer clinical trials do not continue into the Phase III stage because the Food and Drug Administration rejects the proposals for several reasons. Lack of funding, weak or insufficient efficacy data, and bureaucracy are some of the potential pitfalls for pharmaceutical and biotech companies in the approval process.
Daniel Janus, President and CEO of ImmunoGen Inc. was delighted when his firm was given the go ahead:
It's impressive that the overall survival endpoint has already been met - this had been expected to occur well after the submission of the BLA and MAA to the regulatory authorities.
The drug still has a long way to go before it will receive approval by the Food and Drug Administration but it's in global development by Roche following an agreement with ImmunoGen Inc. and Genetech. Roche will also be starting an approval process with the European Medicines agency.
With news of the positive trial results spreading, numerous other sponsors are hopeful of developing similar compounds in breast cancer clinical trials. In keeping with the trend of targeted treatments, pharmaceutical companies and biotechs are especially interested in drugs that kill cells depending on the specific make-up of a tumours rather than just eliminating any rapidly dividing cells in the body. Similar kinds of treatments could also be developed to combat autoimmune diseases like Lupus. Lupus is a debilitating disease which affects the vital organs of the body. It causes protective cells to attack healthy as well as harmful cells. In the first real breakthrough in treating the disease for 50 years, a targeted medication called Benlysta has been approved by the Food and Drug Administration.
The key benefit of targeted treatments is that they avoid the devastating side effects of chemotherapy in which healthy cells are killed alongside invasive cells. This can produce side effects including hair loss, skin lesions, digestive issues and severe fatigue. Results of the T-DM1 trial should see significant investment into breast cancer clinical trials involving targeted treatments.
Contract Research Organisation - PSI CRO
http://www.psi-cro.com
T-DM1 from ImmunoGen Inc. outperforms survival endpoint in Phase III trials.
A recent press release reports that the antibody-drug conjugate Trastuzumab Emtansine or T-DM1 has "significantly improved survival in the EMILIA Phase III Trial." This run of clinical trials was to establish the efficacy of T-DM1 in treating cases of metastatic HER-2 positive breast cancer. Patients enrolled on the trial had already been treated with taxane chemotherapy and Herceptin.
A large number of US breast cancer clinical trials do not continue into the Phase III stage because the Food and Drug Administration rejects the proposals for several reasons. Lack of funding, weak or insufficient efficacy data, and bureaucracy are some of the potential pitfalls for pharmaceutical and biotech companies in the approval process.
Daniel Janus, President and CEO of ImmunoGen Inc. was delighted when his firm was given the go ahead:
It's impressive that the overall survival endpoint has already been met - this had been expected to occur well after the submission of the BLA and MAA to the regulatory authorities.
The drug still has a long way to go before it will receive approval by the Food and Drug Administration but it's in global development by Roche following an agreement with ImmunoGen Inc. and Genetech. Roche will also be starting an approval process with the European Medicines agency.
With news of the positive trial results spreading, numerous other sponsors are hopeful of developing similar compounds in breast cancer clinical trials. In keeping with the trend of targeted treatments, pharmaceutical companies and biotechs are especially interested in drugs that kill cells depending on the specific make-up of a tumours rather than just eliminating any rapidly dividing cells in the body. Similar kinds of treatments could also be developed to combat autoimmune diseases like Lupus. Lupus is a debilitating disease which affects the vital organs of the body. It causes protective cells to attack healthy as well as harmful cells. In the first real breakthrough in treating the disease for 50 years, a targeted medication called Benlysta has been approved by the Food and Drug Administration.
The key benefit of targeted treatments is that they avoid the devastating side effects of chemotherapy in which healthy cells are killed alongside invasive cells. This can produce side effects including hair loss, skin lesions, digestive issues and severe fatigue. Results of the T-DM1 trial should see significant investment into breast cancer clinical trials involving targeted treatments.
Contract Research Organisation - PSI CRO
http://www.psi-cro.com
