Sarepta is the first company to publicly disclose that it's received the designation, for which the FDA had issued a draft guidance last year.

Vepdegestrant showed a benefit for patients with ER-positive, HER2-negative, ESR1-mutated breast cancer who had previously received endocrine-based therapy.

As with the drug's 2023 approval in castration-resistant tumors, it's not clear if it works comparably in all homologous ...

Kura Oncology and Kyowa Kirin submitted data from the KOMET-001 trial, which the agency will review and decide whether to approve the drug by Nov. 30.