Switzerland – Swissmedic Takes Position on Fast-Track Reviews of Tissue-Agnostic Drugs

The Swiss Agency for Therapeutic Products (Swissmedic) has provided advice to developers of drugs that target tumors with certain genetic abnormalities, regardless of the organ affected. Developers of such tissue-agnostic drugs can use Swissmedic’s fast-track pathway if they meet certain criteria.

Knowledge that genetically similar cancers can affect multiple different organs has driven a shift away from targeting tumors based on where they are found in the body. Rather, some companies are developing drugs for approval in all people with a certain genetic marker, regardless of the location of their tumor. This week, EMA made Bayer’s Vitrakvi the first tissue-agnostic drug to win approval in Europe.

Swissmedic has responded to the emergence of tissue-agnostic drugs by updating guidance on its fast-track authorization procedure. The revised guidance features a new annex that discusses the eligibility of tissue-agnostic drugs for the procedure…