Moderna Inc said its experimental optimized mRNA skin cancer vaccine in combination with Merck drug Keytruda has received Breakthrough Therapy Designation from US regulators as an add-on treatment for high-risk patients, reports Independent.
The drug has been granted the Breakthrough tag by the US Food and Drug Administration (FDA) based on data from an interim study that showed the therapy reduced the risk of skin cancer recurrence or death by 44 percent compared to Keytruda alone. Shares of Moderna rose 2.5% to $164 in after-market hours.
The FDA’s Breakthrough Therapy designation is given to accelerate the development and review of drugs intended to treat a serious condition.
The companies said they plan to start late-stage studies into the adjuvant treatment of melanoma in 2023, reports Independent.
“For the first time ever, we have evidence that it’s possible to develop a functional immune response that can treat patients’ cancer from a randomized controlled trial,” says Dr. Stephen Hoge, president of Moderna, said in an interview in Time in late 2022, reports Independent.
“But I do think this is a transformational moment for the field [of cancer treatment], for the company, and, we hope, for patients. We had a lot of success going after viruses, but nobody has ever demonstrated that mRNA vaccines could work in a randomized controlled trial in cancer. We are starting to show with data that they absolutely can, and that they can have a bigger impact in other fields than the one for which they became famous,” Mr Hoge said, reports Independent.
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