The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients
First PARP inhibitor and new hormonal agent combination approved for these patients in Europe
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
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
The decision was driven by results from the Phase III CAPItello-281 trial,
Patients with BRCA mutations often face aggressive disease and poor prognosis
Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population
The discontinuation decision is only on the basis of commercial reasons and is not due to efficacy or safety reasons
Based on data, 1.75 mg/kg dose established as recommended dose for Phase 3 trial of this investigational antibody-drug conjugate
Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, potentially reducing burdens on patients and healthcare systems
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