Olaparib, inotuzumab ozogamicin FDA approvals announced
medwireNews: The US Food and Drug Administration (FDA) has granted approval of olaparib tablets as a maintenance therapy in key groups of women with gynecologic tumors and for the use of inotuzumab ozogamicin for relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
The PARP inhibitor olaparib may now be given in tablet form, at a dose of 300 mg twice daily, to women with recurrent ovarian, fallopian tube, or primary peritoneal tumors with a germline BRCA mutation who have achieved a partial or complete response to platinum-based chemotherapy after at least two other earlier regimens.
Approval of the tablet formulation follows findings from the SOLO-2 study and adds to the earlier FDA approval in 2014 for the original capsule olaparib in the same patient population. The capsule and tablet formulations may not be used interchangeably.
Inotuzumab ozogamicin has been granted FDA approval for the treatment of B-cell precursor ALL in patients with bone marrow blasts of 5% or above and receipt of one or two induction chemotherapy regimens.
Patients with Philadelphia chromosome-positive disease must also have previously received at least one tyrosine kinase inhibitor and standard chemotherapy before using the antibody–drug conjugate.
As previously reported, inotuzumab ozogamicin has been associated with severe hepatotoxicity and the prescribing information includes a boxed warning highlighting the risk of side effects including veno-occlusive disease and sinusoidal obstruction syndrome.
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