medwireNews: The EMA has recommended changes to the indications for the PARP inhibitor olaparib and the antibody–drug conjugate trastuzumab deruxtecan in breast cancer.
Specifically, the Committee for Medicinal Products for Human Use (CHMP) adopted a new indication for olaparib as an adjuvant treatment option for adult patients with germline BRCA1 or BRCA2 mutations who have received prior neoadjuvant or adjuvant chemotherapy for HER2-negative, high-risk early breast cancer. Olaparib can be given alone or in combination with endocrine therapy.
The recommendation is based on the phase 3 OlympiA trial, which showed a significant improvement in invasive and distant disease-free survival as well as overall survival with adjuvant olaparib versus placebo in this patient population.
The CHMP also proposed a change to the existing indication for trastuzumab deruxtecan, such that the agent can now be used as monotherapy in adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more, rather than two or more as per the previous decision, anti-HER2-based regimens.
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