Immunomedics Inc’s cancer drug Trodelvy, which received accelerated US regulatory approval in April, extended survival time in previously treated patients with an advanced form of breast cancer in a clinical trial, the company said.
The positive new data could improve Immunomedics’ chances of winning full US Food and Drug Administration (FDA) approval for Trodelvy. Immunomedics is being acquired by Gilead Sciences for $21 billion.
The FDA granted the drug accelerated approval for its use in metastatic triple-negative breast cancer (mTNBC) patients who had previously received at least two prior therapies. Its continued approval is contingent upon the FDA’s verification of a clinical benefit in confirmatory trials.
Trodelvy reduced the risk of death by 52 per cent, with a median overall survival of 12.1 months for patients receiving the drug in the late-stage confirmatory trial compared to 6.7 months for patients receiving chemotherapy, Immunomedics said.
Immunomedics said it would file for full FDA approval of Trodelvy in the fourth quarter under the FDA’s Real-Time Oncology Review (RTOR) process that allows the agency to review the data before the company submits its marketing application.
Trodelvy is an antibody-drug conjugate that delivers an anti-cancer drug called SN-38 directly to cancer cells by binding to a protein called Trop-2 found on their surface.
It is also being tested in multiple ongoing clinical trials for its potential use against urothelial cancer, non-small cell lung cancer and other forms of breast cancer, the company said.
Trodelvy’s current label carries a boxed warning – the FDA’s harshest – that flags risks of severe diarrhoea and neutropenia, an abnormally low count of a type of white blood cells.
The results were due to be presented at the European Society for Medical Oncology meeting, the company said.