Moderna’s cancer vaccine is close to reality

by time news
  • According to Statista, the global market for cancer drugs is expected to reach a value of $215 billion by the year 2030.

  • The global cancer and tumor profiling market is estimated to grow from around $11 billion to nearly $32 billion from 2021 to 2030.

  • According to Statista, the global cancer vaccine market will be worth more than $24 billion by 2030.

A cancer vaccine made by Moderna has been given “breakthrough therapy” status by health officials, paving the way for fast-track approval.

Moderna’s cancer vaccine, given together with an immunotherapeutic drug, is used to treat patients recovering from advanced melanoma who are at risk of the tumors coming back.

A phase two trial showed that the combination reduced the chances of relapse or death in operated patients by 44%, compared to the immunotherapeutic drug alone.

According to those reported by other media, the promising results led the Food and Drug Administration (FDA) yesterday to issue the designation, which could shorten the approval period by up to eight months.

Hope in the fight against cancer

The experimental therapy consists of Moderna’s injection and Merck’s immunotherapy drug Keytruda.

The new “breakthrough” label means the FDA believes the vaccine may “fill unmet medical needs in the treatment of serious or life-threatening diseases.” In practice, this means that the agency will hold frequent meetings with Moderna on the progress of the vaccine throughout its development.

The move also makes the therapy eligible for accelerated approval and priority review by the FDA, if Moderna files a new application for it. The FDA would respond within 60 days.

If granted, the priority review would mean that the regulatory body would make a decision on the approval of the therapy within six months of Moderna’s submission of the application, instead of the standard ten months of review.

How is this vaccine administered?

The vaccine is given after surgery to prevent tumor recurrence and is tailored to each patient, meaning no two injections will be the same.

Merck and Moderna said they plan to start a phase three study of the therapy this year, testing it in thousands of patients.

They will also “rapidly expand” the study to other types of cancer, including non-small cell lung cancer. In the ongoing phase two study, 157 patients received personalized vaccines along with Keytruda, Merck’s immunotherapy drug.

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