FDA approved Talzenna (talazoparib) for BRCA-Mutated Breast Cancer and HRR-Mutated mCRPCFDA approved Talzenna for Two Kinds of Advanced Cancer

Talzenna is a poly (ADP-ribose) polymerase (PARP) inhibitor.

Talzenna is indicated for: - Breast Cancer: As a single agent for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for Talzenna. - HRR Gene-Mutated mCRPC: In combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). Select patients based on the presence of alterations in genes directly or indirectly involved in HRR (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C). An FDA-approved test for the detection of HRR gene mutations for use with Talzenna is not currently available.

- Breast Cancer: The recommended dosage is 1 mg taken orally once daily until disease progression or unacceptable toxicity. - HRR Gene-Mutated mCRPC: The recommended dosage is 0.5 mg taken orally once daily in combination with enzalutamide until disease progression or unacceptable toxicity. Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Refer to the enzalutamide prescribing information for recommended enzalutamide dosing. - Administration: Take with or without food. Swallow capsules whole. Do not open or dissolve. If a patient vomits or misses a dose, instruct them to take the next prescribed dose at the usual time. - Dosage Modifications for Adverse Reactions: Consider interruption with or without dose reduction based on severity. Recommended dose reductions: - Breast Cancer: Starting dose 1 mg once daily; first reduction 0.75 mg; second reduction 0.5 mg; third reduction 0.25 mg. - mCRPC: Starting dose 0.5 mg once daily; first reduction 0.35 mg; second reduction 0.25 mg; third reduction 0.1 mg. Discontinue if more than three dose reductions are required. Monitor complete blood counts monthly and as clinically indicated. Withhold Talzenna for hemoglobin <8 g/dL, platelet count <50,000/μL, or neutrophil count <1,000/μL until levels resolve (hemoglobin ≥9 g/dL, platelets ≥75,000/μL, neutrophils ≥1500/μL) and resume at a reduced dose. For non-hematologic Grade 3 or 4 adverse reactions, withhold until ≤Grade 1 and consider resuming at a reduced dose or discontinue. - Renal Impairment: For breast cancer, recommended dosage is 0.75 mg once daily for moderate renal impairment (CLcr 30-59 mL/min) and 0.5 mg once daily for severe renal impairment (CLcr 15-29 mL/min). For mCRPC, see full prescribing information (label text truncated).

Trial data not available in label.

Not reported in label (label text truncated). Monitor complete blood counts monthly due to potential hematologic adverse reactions.

Talzenna provides a targeted oral PARP inhibitor option for patients with gBRCAm HER2-negative locally advanced or metastatic breast cancer and for patients with HRR gene-mutated mCRPC in combination with enzalutamide