The FDA has approved Inluriyo in combination with Verzenio for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer following progression on endocrine therapy.

The FDA has granted accelerated approval to Etcamah in combination with a CDK4/6 inhibitor for adults with ESR1-mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer.

The two regulatory decisions could expand first-line treatment options for patients with ESR1-mutant ER-positive disease and HER2-positive metastatic breast cancer, although Enhertu still requires European Commission approval.

If authorised, the combination would add an antibody-drug conjugate-based first-line option for eligible European patients with unresectable locally advanced or metastatic triple-negative breast cancer.

The approval of Revtorpyk (gedatolisib) gives Celcuity a new treatment option for HR-positive, HER2-negative breast cancer patients without PIK3CA mutations, following positive Phase III VIKTORIA-1 data showing improved progression-free survival.

Genentech has secured global rights to a fragment-based drug discovery programme targeting a key regulator of breast cancer cell growth.