ZEJULA

批准信原文要点

This Prior Approval supplemental new drug application provides for updates to the Indications and Usage (1.2), Dosage and Administration - Patient Selection (2.1) and Clinical Studies (14.2) sections of the Prescribing Information to add information about the Myriad BRACAnalysis companion diagnostic.

批准信原文要点

This Prior Approval Supplemental (PAS) new drug application provides for restricting the indication for maintenance treatment of patients with recurrent ovarian cancer to those with a germline BRCA mutation only.

批准信原文要点

This Prior Approval sNDA provides for the removal of the following indication: Zejula for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with 3 or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: • a deleterious or suspected deleterious BRCA mutation, or • genomic instability and who have progressed more than 6 months after response to the last platinum-based chemotherapy

批准信原文要点

Changes Being Effected supplemental new drug application 024 proposes to revise a typographical error identified in Section 6; Adverse Reactions, in Table 6, of the currently approved USPI.

批准信原文要点

Prior Approval supplemental new drug application 022 proposes to revise the Zejula capsule bottle label as follows: • Redesigned to include the capsule image, and to change the color scheme to purple to conform to GSK corporate standards • Add the previously approved March 3, 2021text for tartrazine from Supplements 19 and 20 to the bottle label • Include the missing required technical elements (i.e., lot/expiration visuals)

批准信原文要点

Supplement 020 • Addition of a new Subsection 2.4 Dosage Adjustment for Hepatic Impairment, to Section 2, Dosage and Administration • Updates to Subsection 8.7 Hepatic Impairment and Subsection 12.3 Pharmacokinetics, following the completion of Study 3000-01-003

批准信原文要点

Supplement 019 • Addition of Posterior Reversible Encephalopathy Syndrome to Section 5, Warnings and Precautions • Addition of Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) to Section 5, Warnings and Precautions • Addition of hypertensive crisis to Subsection 6.2, Postmarketing Experience • Addition of pancytopenia to Section 5, Warnings and Precautions and Subsection 6.2, Postmarketing Experience • Heading for Subsection 5.3 was modified to include ‘Hypertension’ • Updates were made to the Highlights of Prescribing Information, Section 17 Patient Couseling Information and the Patient Information sections of the label to reflect the above mentioned revisions.

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for minor updates to the Zejula (niraparib) Capsules 30-capsules bottle label.

批准信原文要点

The Prior Approval supplemental new drug application 017 (S-017) provides for the use of Zejula for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

批准信原文要点

The Changes Being Effected supplemental new drug application 015 (S-015) provides for the addition of febrile neutropenia as a preferred term to Section 6 (Adverse Reactions).

批准信原文要点

This Changes Being Effected supplemental new drug application provides for the addition of preferred terms for the Adverse Reactions section and additional administrative changes to the USPI.

批准信原文要点

This Prior Approval supplemental new drug application provides for a new indication: for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: a deleterious or suspected deleterious BRCA mutation, or genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Zejula.