The US Food and Drug Administration (FDA) has halted enrollment in all clinical trials of Mersana Therapeutics' cancer drugs, the company announced on Tuesday. The decision comes after a patient in one of the trials died from a serious adverse event that was deemed to be related to the therapy.
Mersana's lead drug, XMT-2056, is a first-in-class antibody-drug conjugate (ADC) that is being developed to treat a variety of cancers. The drug is currently in Phase 1 and Phase 2 clinical trials.
The FDA's decision to halt enrollment in the trials is a major setback for Mersana. The company's stock price fell by more than 50% in pre-market trading on Tuesday.
Mersana said that it is working with the FDA to understand the cause of the patient's death and to determine how to resume enrollment in the trials. The company said that it expects to provide an update on the situation in the coming weeks.
The FDA's decision to halt enrollment in Mersana's trials is a reminder of the risks associated with developing new cancer drugs. ADCs are a relatively new class of drugs, and they have been associated with a number of serious side effects, including death.
Despite the risks, ADCs are seen as a promising new approach to cancer treatment. They work by linking a monoclonal antibody to a cytotoxic drug. The antibody binds to a specific target on cancer cells, and the drug is then released, killing the cells.
ADCs have shown promise in clinical trials, but they have also been associated with a number of serious side effects. In some cases, the drugs have caused the immune system to attack healthy cells, leading to serious complications.
The FDA's decision to halt enrollment in Mersana's trials is a reminder of the risks associated with developing new cancer drugs. However, ADCs are a promising new approach to cancer treatment, and they are likely to continue to be developed and tested in clinical trials.
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