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…
