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CHMP

The European Commission will review CHMP's recommendation and issue a decision on marketing authorization for the drug by the end of September.

Enhertu, or trastuzumab deruxtecan, will also receive accelerated assessment by the European Medicines Agency's Committee for Medicinal Products for Human Use.

The agency based its decision on the results of the POLO trial, in which patients on olaparib had a median progression-free survival of 7.4 months compared to 3.8 months on placebo.

The agency made its decision based on the SOLAR-1 study showing a five-month progression-free survival benefit for Piqray plus fulvestrant over just fulvestrant.

Roche noted that it expects the European Commission to approve trastuzumab emtansine in the near future, based on the EMA committee's recommendation.

The European Commission will review CHMP's recommendation and is slated to issue a final decision regarding marketing authorization later this year.

The recommendation is based on a study in which NSCLC patients without EGFR mutations or ALK rearrangements lived longer on the combo than just on chemo.

CHMP endorsed the immunotherapy combination for women in Europe with triple-negative, advanced cancers based on results from a Phase III trial reported last December.