Roche submits new version of Herceptin for US approval
pharmafile | July 7, 2010 | News story | Research and Development, Sales and Marketing | Herceptin, Roche, breast cancer
Roche has submitted a new version of its blockbuster Herceptin (trastuzumab) to US regulators for approval to treat advanced breast cancer.
Trastuzumab-DM1 (T-DM1) builds on the original form of the cancer drug by using a new, targeted antibody that can kill breast cancer cells at a later stage of the disease after the failure of other chemotherapy and cancer drugs.
The submission is based on the results of a phase II study that showed T-DM1 shrank tumours in one-third of women who had received on average seven prior medicines for advanced HER2-positive breast cancer.
The phase II study TDM4374g was a single-arm, multi-centre trial designed to assess single-agent T-DM1 in 110 women with HER2-positive advanced breast cancer whose disease had worsened after receiving at least two prior HER2-targeted treatments – Herceptin and GSK’s Tyverb (lapatinib) in the metastatic setting, as well as an anthracycline, a taxane and capecitabine.
The news is also a boost for US biotech firm ImmunoGen as the drug comprises its DM1 cancer-cell killing agent linked to Herceptin, and will be the first product developed by ImmunoGen that has been filed for approval.
Hal Barron, global development and chief medical officer, said: “While we’ve made great strides in treating HER2-positive breast cancer, there is a group of people whose breast cancer will come back after many treatments, leaving them with very limited options.
“Data from studies have shown that T-DM1 shrank tumors in these people, so we are excited to have submitted this application to the FDA in hopes of offering a potential new medicine to people with this type of breast cancer.”
T-DM1 is an antibody-drug conjugate (ADC), also known as an ‘armed antibody’, that DM1 attaches to Herceptin and the chemotherapy DM1 together using a stable linker designed to keep T-DM1 in one piece until it reaches specific cancer cells.
The Herceptin antibody binds to the HER2-positive cancer cells, and aims to block out-of-control signals that make the cancer grow while also calling on the body’s immune system to attack the cells. Once the T-DM1 is absorbed into those cancer cells, it is designed to destroy them by releasing the DM1.
This week, Roche’s ambitions to expand Herceptin, best known as a breast cancer treatment, into other indications received a blow when UK cost-effectiveness body NICE did not recommend it for gastric cancer in preliminary guidance.
Ben Adams
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