The US Food and Drug Administration cleared the medicine for patients who have HER2-positive solid tumors that have spread or can’t be removed with surgery, the company said. These patients have already received prior treatment and don’t have any good alternatives.
Enhertu is the first in a promising new class of drugs called antibody drug conjugates to win such a broad clearance. These therapies deliver high medicine doses directly to tumors while minimizing damage to surrounding tissues. The field has attracted drugmakers including Pfizer Inc. and Johnson & Johnson.
Astra shares were little changed, trading at £105.50 in London.
“This approval also elevates the importance of testing for biomarkers,” Dave Fredrickson, executive vice president of Astra’s oncology unit, said in a statement.
Enhertu, a joint effort between Astra and Japan’s Daiichi, is already approved for multiple other indications including breast, lung and gastric cancers.Speaking at the company’s earnings in February, Fredrickson pointed to further opportunities for Enhertu sales to grow both in the US and Europe.
