EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer
The validations confirm the completion of the applications and commence the scientific review process
The validations confirm the completion of the applications and commence the scientific review process
About 75% of all primary liver cancers in adults are HCC and up to 30% of HCC patients are eligible for embolisation
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
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