Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Furthering cell therapy ambition across oncology and autoimmune diseases
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients
Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival
Positive opinions based on significant survival benefit
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
Results reinforce commitment to next-generation oral SERD development programme
The Phase 3 SOLO-1 trial demonstrated 67% of advanced ovarian cancer patients with BRCA mutations receiving LYNPARZA were alive at seven years versus 47% of placebo patients
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
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