Durvalumab, abemaciclib approvals announced by EMA
medwireNews: The EMA has recommended approval for the use of durvalumab and abemaciclib in select patients with non-small-cell lung cancer (NSCLC) and locally advanced or metastatic breast cancer, respectively.
The Committee for Medicinal Products for Human Use (CHMP) has supported the granting of marketing authorisation for the use of durvalumab in locally advanced, inoperable NSCLC.
Criteria for the monoclonal antibody include tumour PD-L1 expression of at least 1% and no evidence of disease progression after platinum-based chemoradiation. The treatment was previously made available to US patients with stage III disease by the FDA, based on the results from the PACIFIC trial.
The CHMP has also adopted a positive opinion for marketing authorisation for use of the CDK4 and CKD6 inhibitor abemaciclib in women with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. The agent may be given alongside an aromatase inhibitor or fulvestrant during initial endocrine-based therapy or as a monotherapy for patients who have completed endocrine therapy.
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